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Showing 12 of 4196 trials

Children's Health, Respiratory Inflammation and Short-term Air Pollution

NCT07431021
Recruiting
Conditions Asthma Acute, Respiratory
Phase NA
Enrollment 330
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-10
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this study is to see if physical activity in high air pollution is worse than rest in high air pollution.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Single Group Primary purpose: Prevention Masking/blinding: None

Interventions / Regimen

  • Behavioral: science lesson — children have a 90 minute science lesson outdoors
  • Behavioral: PE Lesson — CHildren have a 90 minute PE lesson outdoors

Primary Outcomes

  • "Airway resistance" measured by Oscillometry at R5 (Pre-24 hour post exposure)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-10-20
Completion: 2027-07-01
Eligibility
Age: 7 Years – 11 Years
Sex: ALL
Volunteers: true
Enrollment: 330 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Queen Mary University of London
Collaborators: Imperial College London
Principal Investigators:
  • James Scales, PhD (PRINCIPAL_INVESTIGATOR) - Queen Mary University London
  • Abigail Whitehouse, PhD, MD (PRINCIPAL_INVESTIGATOR) - QMUL
Contact Information
Study Contact:
James Scales, PhD
+447533897264
j.scales@qmul.ac.uk
Abigail Whitehouse, MD,PhD
a.whitehouse@qmul.ac.uk
James Scales
07533897264
j.scales@qmul.ac.uk
Faculty of Medicine and Dentistry
Interventions
  • Behavioral: science lesson — children have a 90 minute science lesson outdoors
  • Behavioral: PE Lesson — CHildren have a 90 minute PE lesson outdoors
Study Locations (1 sites)
Faculty of Medicine and Dentistry, London, E1 2AB United Kingdom
Eligibility Criteria
Inclusion Criteria: * Attending schools in Central and East London that have been recruited to the study Exclusion Criteria: * Not able to engage with PE lessons on safety grounds, reported by their parents. * Children with learning or physical disabilities sufficient for them to be unable to give informed assent to the study, or to carry out study procedures

Swiss Paediatric Airway Cohort

NCT03505216
Recruiting
Conditions Asthma, Wheezing, Cough, Exercise Induce...
Phase Not Applicable
Enrollment 6000
Locations 12 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-10
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Study Details Design, interventions, and primary outcomes

About This Study

The Swiss Paediatric Airway Cohort (SPAC) is a national, prospective clinical cohort of children and adolescents who visit physicians in Switzerland for recurrent wheeze, cough, and exercise- or sleep-related respiratory problems. SPAC aims to answer important questions on clinical phenotypes, prognosis, diagnosis and treatment. SPAC is part of routine care, and only clinically indicated investigations are done. The comprehensive baseline assessment includes a detailed questionnaire to families, plus test results, diagnoses and treatments from hospital records. Follow-up is via monthly questionnaires the first 12 months and thereafter annual questionnaires to families, and data from follow-up visits. Currently, 4344 patients from 10 clinics and hospitals in Switzerland (Aarau, Basel, Bern, Chur, Horgen, Lausanne, Luzern, St. Gallen, Worb, Zurich) have been enrolled. SPAC provides real-life data on children visiting the Swiss health care system for common respiratory problems. It will provide a research platform for health services research, and for nested clinical and transitional studies. Publications and plain language summaries are listed on the study website: https://www.spac-study.ch/publikationen/

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Primary Outcomes

  • Wheeze (1 year from inclusion in SPAC study)
  • Cough apart from colds (1 year from inclusion in SPAC study)
  • Exercise-induced dyspnea (1 year from inclusion in SPAC study)
  • Reduced lung function (1 year from inclusion in SPAC study)
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Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2017-06-06
Completion: 2030-06-01
Eligibility
Age: 0 Years – 16 Years
Sex: ALL
Volunteers: false
Enrollment: 6000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Bern
Principal Investigators:
  • Claudia E Kuehni, Prof. (STUDY_DIRECTOR) - Institute of Social and Preventive Medicine
Contact Information
Study Contact:
Claudia E Kuehni, Prof.
+41(0)316843507
claudia.kuehni@unibe.ch
Anja Jochmann
University Children's hospital Basel, UKBB
Anja Jochmann
University Children's hospital Basel, UKBB
Interventions
N/A
Study Locations (12 sites)
Vienna Open Medical Institute, Vienna, Austria
Children's hospital Aarau, Aarau, Switzerland
University Children's hospital Basel, UKBB, Basel, Switzerland
Institute of Social and Preventive Medicine, Bern, 3012 Switzerland
University Children's Hospital Bern, Inselspital, Bern, Switzerland
Children's Hospital Chur, Chur, Switzerland
Pulmonology clinic, Horgen, Horgen, Switzerland
University Children's hospital Lausane, CHUV, Lausanne, Switzerland
Children's hospital Lucerne, Lucerne, Switzerland
Children's hospital St. Gallen, Sankt Gallen, Switzerland
Eligibility Criteria
Inclusion Criteria: * Children and adolescents aged 0-16 years * Resident in Switzerland * Seen in a paediatric pulmonary outpatient clinic due to respiratory problems * Parents and patients above age 14 must be able to sign an informed consent form Exclusion Criteria: Prior diagnosis of cystic fibrosis, primary ciliary dyskinesia, severe heart disease, oncological disease, neuromuscular disease or severe disability

A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up

NCT06732414
Recruiting
Conditions Allergy, Sinus Disorders, Atopic Disease...
Phase Not Applicable
Enrollment 10000
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-10
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Study Details Design, interventions, and primary outcomes

About This Study

Background: Allergic or sinus diseases can affect the skin, sinuses, airways, and other parts of the body. Examples include pollen and environmental allergies, food allergies, asthma, and eczema. To learn more about how to prevent and treat these diseases, researchers need to study data, blood, fluid, and tissue samples from people affected by them. Objective: To collect data, blood, fluid, and tissue samples from people with allergic or sinus diseases. Eligibility: People aged 3 to 100 years with allergic or sinus diseases. Design: Participants will have at least one clinic visit, and most participants will have a baseline visit, annual visit, and an end of study visit. The duration of the study is 1 to 3 years. During the first clinic visit, the following procedures will be done to collect data, blood, fluid, and tissue samples: * Blood will be collected. * Cells and fluid may be collected from the inside of the nose using a long swab, and a small piece of skin may be scraped from inside the nose. * Skin cells will be collected by rubbing with a cotton swab. * A urine sample will be collected. * Allergy skin prick tests. Allergy-causing substances will be placed on the back or arm and the skin underneath gently scratched. If the participant is allergic to the substance, the skin may become red, itchy, and swollen locally ( at the site of the test). * Lung function test. Participants will breathe into a machine that measures the air moving in and out of their lungs. * If, as part of their routine care, participants are undergoing procedures such as having nasal polyps removed, skin tissue samples taken, or gastrointestinal biopsies, additional tissues may be collected for this study. * Participants will complete online questionnaires regarding their symptoms, health, and life. Participants may return for more visits for up to 3 years.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Primary Outcomes

  • Create a repository of clinical, laboratory, and diagnostic data and specimens from a cohort of suspected or confirmed atopic or allergic individuals with diverse disorders seen by allergist-immunologists and rhinologists. (20 years)
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Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-01-28
Completion: 2045-11-01
Eligibility
Age: 3 Years – 100 Years
Sex: ALL
Volunteers: false
Enrollment: 10000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigators:
  • Paneez Khoury, M.D. (PRINCIPAL_INVESTIGATOR) - National Institute of Allergy and Infectious Diseases (NIAID)
Contact Information
Study Contact:
Hye Jeong C Bolan, R.N.
(301) 594-1233
NIAIDMADREP@NIH.GOV
Paneez Khoury, M.D.
(301) 402-3673
paneez.khoury@nih.gov
NIH Clinical Center Office of Patient Recruitment (OPR)
800-411-1222
ccopr@nih.gov
National Institutes of Health Clinical Center
Interventions
N/A
Study Locations (1 sites)
National Institutes of Health Clinical Center, Bethesda, Maryland 20892 United States
Eligibility Criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1)Aged 3 to 100 years. 2a) Suspected or confirmed allergic, atopic, respiratory, or nasal/sinus disorder or have suspected or confirmed history of an immune dysregulatory disorder, OR 2b) Have a clinical history of an immediate hypersensitivity reaction to aeroallergens, food, insect stings, or medications. 3\) Able to provide informed consent. 4\) Have or are willing to obtain a non-NIH primary physician who will manage all health conditions and be responsive for emergency medical treatment, if required. 5\) Willing to allow storage of blood, skin swabs, nasal fluid/brushings, bodily fluids, and other clinically appropriate tissue specimens or data generated during participation for future use in medical research. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Any condition(s) or diagnosis, physical and/or psychological, that the investigator feels precludes the patient from participation in the study. 2. For additional skin biopsies only: 1. Individuals who have a history of keloid formation 2. Children (\<18 years old) 3. Participants who are pregnant 3. For additional nasal-sinus polyp biopsies only: 1. Individuals on blood thinners unless they have already been stopped for the procedure 2. Children (\<18 years old) 3. Participants who are pregnant 4. For skin prick testing a. Participants who are pregnant. 5. Endoscopic Biopsy 1. Uncontrolled asthma or Grade 3 or higher by the American Society of Anesthesiologist's Physical Status Classification System (https://www.asahq.org/standards-and-practice-parameters/statement-on-asaphysical-status-classification-system) 2. History of adverse reaction to conscious sedation or general anesthesia required for endoscopy 3. Hemoglobin \< 11 g/dL 4. Platelet count \< 100,000 microL 5. Pregnant or breastfeeding 6. Severe hypoxemia due to chronic pulmonary disease 7. Recent abdominal surgery 8. Anticoagulant therapy that cannot be interrupted 9. Younger than 18 years of age Participants will be selected in an equitable manner from the available pool of potentially eligible individuals, without regard to factors such as sex, gender, race, ethnicity, sexual orientation, or socioeconomic status.

Comparison of Microglial Activation in Severe Asthma and Healthy Controls

NCT06299592
Recruiting
Conditions Asthma
Phase Not Applicable
Enrollment 100
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-10
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to learn about how asthma influences brain function. The main questions it aims to answer are: * How airway inflammation in asthma affects the brain; and, * Whether airway inflammation in asthma is related to symptoms of depression and anxiety Over the course of 3 visits, participants will: * Complete questionnaires * Complete computer tasks * Undergo allergy skin test and breathing tests * Give two blood samples * Give a sputum sample * Complete brain imaging scans Researchers will compare results between participants with asthma, and participants who do not have asthma.

Design

Study type: Observational Observational model: Case Control Time perspective: Prospective

Interventions / Regimen

  • Combination Product: PET/MRI using [18F]FEPPA tracer — PET/MRI scans with \[18F\]FEPPA radiotracer selective for translocator protein (TSPO) binding, which is elevated in activated microglia

Primary Outcomes

  • Binding of [18F]-FEPPA (Up to 2 weeks)
Interested in this trial?
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Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-03-06
Completion: 2028-08
Eligibility
Age: 18 Years – 75 Years
Sex: ALL
Volunteers: true
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Wisconsin, Madison
Collaborators: National Institute on Aging (NIA)
Principal Investigators:
  • Melissa Rosenkranz, PhD (PRINCIPAL_INVESTIGATOR) - University of Wisconsin, Madison
Contact Information
Study Contact:
Rachel Kaspari
608-263-0524
maia@medicine.wisc.edu
Danika Klaus
608-263-0524
maia@medicine.wisc.edu
Janelle Grogan
608-263-0524
jegrogan@medicine.wisc.edu
Center for Healthy Minds
Interventions
  • Combination Product: PET/MRI using [18F]FEPPA tracer — PET/MRI scans with \[18F\]FEPPA radiotracer selective for translocator protein (TSPO) binding, which is elevated in activated microglia
Study Locations (1 sites)
Center for Healthy Minds, Madison, Wisconsin 53703 United States
Eligibility Criteria
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document * Individuals with no health concerns that might affect the outcome of the study * Age 18-75 years of age * Ability to tolerate a simulated MRI brain scanning session * In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements * High-affinity TSPO-binding genotype. Mixed (high/low) binding-affinity genotype may be included at PIs discretion * For participants with severe asthma: * Physician diagnosis of asthma for at least six months prior to screening (can be determined at the discretion of an asthma/allergy physician member of the study team) * Severe asthmatics must meet the ATS definition of severe asthma and/or be currently receiving a GINA Step 4 or 5 therapy or daily treatment of 320mcg budesonide. Therapy may include ongoing use of currently approved biologic immunomodulators Exclusion Criteria: * Current smoker (defined as more than 0.5 pack per week for the past 6 months and any smoking within two weeks of study procedures) or has a smoking history exceeding 5 pack years within the last 10 years * Currently receiving allergen immunotherapy unless on stable dose. * Use of psychotropic medication that might affect function of neurocircuitry implicated in our hypotheses (at the discretion of the PI/Co-I) * Inability to hold medications detailed in the medication hold schedule * Needle phobia or claustrophobia * Major health problems such any of the following in the last 6 months: stroke/TIA, myocardial Infarction, stent placement, or acute coronary syndrome are definitively exclusionary. Decisions regarding other major health problems, such as autoimmune disease, history of carotid stenosis, heart disease, uncontrolled hypertension, lung diseases other than asthma, history of significant arrhythmias, etc. will be based upon the judgement of the PI/Co-I. * Use of biologic medication that might affect signaling pathways under investigation (at the discretion of the PI/Co-I) * Pre-existing chronic infectious disease * Scheduled use of non-selective beta-blockers prior to each study visit. * Use of an investigational drug within 30 days of entering the study. This criterion will be reviewed on a case by case basis by the PI/Co-I to determine appropriate washout period. Appropriate wash out period may be greater than 30 days depending on the half-life of the investigational drug. Participants may be eligible for study participation after completing the washout period designated by the PI or Co-I (physician only). * Any MRI incompatibility as determined by most current MRI screening form * History of a diagnosed bipolar disorder, schizophrenia, or schizoaffective disorder * History of serious head trauma or seizure disorder (can be included at the discretion of the PI or Co-I) * Unable, in the judgement of the investigator, to comply with directions and/or tolerate the procedures required for participation in this study * Pregnant or breast-feeding or has a planned pregnancy during the course of the study * Any other medical condition or disease that would impact participant safety or data integrity in the opinion of the PI/CO-I

Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping

NCT06385236
Recruiting
Conditions Moderate to Severe Asthma
Phase PHASE4
Enrollment 120
Locations 3 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-10
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Study Details Design, interventions, and primary outcomes

About This Study

In this study, a new method will be used to evaluate response to 2 approved biologic therapies, and assess how well each patient responds to each asthma treatment. This study will measure the response to these treatments using genomic and biologic measurements obtained from participants biosamples. By evaluating response to 2 different biologic therapies, this study has the potential to provide an in-depth understanding of the mechanisms underlying severe asthma that will inform and change treatment decisions, and may ultimately lead to a change in the way that asthma patients are evaluated for potential personalized therapies and maximize the probability that the subject will respond to treatment.

Design

Study type: Interventional Phases: Phase4 Allocation: Randomized Intervention model: Crossover Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Biological: Dupilumab — Dupilumab, an interleukin-4 receptor treatment, will be administered through a subcutaneous injection, the initial dose of 600 mg will be administered at two different injection sites (300 mg per injection), followed by a single dose of 300 mg administered every other week (Q2W). Participants may self-administer injection after proper training.
  • Biological: Benralizumab — Benralizumab, an interleukin-5 receptor treatment, will be administered through a subcutaneous injection every 4 weeks (Q4W). Participants may self-administer injection after proper training.

Primary Outcomes

  • Predicting asthma outcomes and therapeutic responses (After 16 weeks (for each biologic))
  • Responses to the biologic therapies at the single cell level (After 16 weeks (for each biologic))
  • Unique asthma subgroups clinical and molecular endotype approaches (After 16 weeks (for each biologic))
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2024-02-19
Completion: 2028-01-31
Eligibility
Age: 18 Years – 75 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of California, San Diego
Collaborators: Mayo Clinic, Yale University, University of Arizona, Harvard University, Brigham and Women's Hospital, National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Kelan Tantisira, MD (PRINCIPAL_INVESTIGATOR) - University of California, San Diego
Contact Information
Study Contact:
Clinical Trial Operations and Data Management Specialist UA-DCC
520-626-9552
bio5-epiphanydcc@arizona.edu
Karalyn Folmes, Ph.D.
480-301-4298
folmes.karalyn@mayo.edu
Mayo Clinic
Gene R Bleecker, MD
Mayo Clinic
Interventions
  • Biological: Dupilumab — Dupilumab, an interleukin-4 receptor treatment, will be administered through a subcutaneous injection, the initial dose of 600 mg will be administered at two different injection sites (300 mg per injection), followed by a single dose of 300 mg administered every other week (Q2W). Participants may self-administer injection after proper training.
  • Biological: Benralizumab — Benralizumab, an interleukin-5 receptor treatment, will be administered through a subcutaneous injection every 4 weeks (Q4W). Participants may self-administer injection after proper training.
Study Locations (3 sites)
Mayo Clinic, Scottsdale, Arizona 85259 United States
University of California, San Diego, La Jolla, California 92093 United States
Yale University, New Haven, Connecticut 06520 United States
Eligibility Criteria
Inclusion Criteria: * Stated willingness to comply with all study procedures and availability for the duration of the study. * Stable asthma medications: No change in asthma medications for the past 2 months: 1. Use of medium or high dose inhaled corticosteroids (ICS) AND 2. Use of an additional asthma controller medication. * Baseline poor or uncontrolled asthma. * Evidence of asthma demonstrated by either bronchodilator reversibility (either at screening or by historical evidence) or methacholine responsiveness (by historical evidence). * Agreement to adhere to Lifestyle Considerations throughout study duration. Exclusion Criteria: * Current participation in an interventional trial (e.g. drugs, diets, etc.). * Currently on an asthma biologic or having been on biologic within 3 months of screening. * Enrollment in a clinical trial where the study medication was administered within the past 60 days or within 5 half-lives (whichever is greater). * Physician diagnosis of other chronic pulmonary disorders associated with asthma-like symptoms, including, but not limited to, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways. * Receiving one or more immune-modulating therapies for diseases other than asthma. This includes biologics that are also approved for asthma. * Receiving methotrexate, mycophenolate (CellCept®), or azathioprine (Imuran®). * Receiving aero allergen immunotherapy and not on at least 3 months of maintenance allergen immunotherapy. * Underwent a bronchial thermoplasty within the last two years. * Born before 30 weeks of gestation. * Uncontrolled hypertension, defined as systolic blood pressure \> 160 mm/Hg or diastolic blood pressure \> 100 mm/Hg. * History of malignancy except non-melanoma skin cancer within the last five years. * History of smoking: 1. If \<45 years old: Smoked for ≥5 pack-years\* 2. If ≥45 years old: Smoked ≥ 10 pack years. * Active use of any inhalant \>1 time per month in the past year. * Substance abuse within the last year. * Unwillingness to practice medically acceptable birth control or complete abstinence during the study, current pregnancy, or lactation. * Requirement for daily systemic corticosteroids at the time of screening. * Respiratory infection within 1 month of screening. * Intubation for asthma in the last 12 months. * Any clinically significant abnormal findings in the history, physical examination, vital signs, electrocardiogram, hematology or clinical chemistry during run-in period, which in the opinion of the site investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study. * BMI \> 38. * Allergic to any of the drugs, biologics or chemicals used in this study.

Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)

NCT05814510
Recruiting
Conditions Asthma in Children
Phase NA
Enrollment 1000
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-10
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The long-term goal is to implement an evidence-based asthma intervention based on the Center for Disease Control's recommended framework (EXHALE) within Baltimore City Public Schools (BCPS). As part of a stepped wedge pragmatic trial the investigators will: 1. Evaluate the effectiveness of a tailored implementation plan of Asthma CHAMPS in 32 Baltimore city elementary schools to reduce asthma disparities. 2. Conduct a pragmatic trail using a stepped wedge design to evaluate implementation of a school and home asthma intervention program to reduce asthma-related absences, healthcare utilization and exacerbations and improve asthma control, among children enrolled in 32 Baltimore City elementary schools. 3. Use qualitative methods (observation and semi structured interviews) to obtain stakeholder feedback (parents, community health workers, school personnel and administrators) on impact of Asthma CHAMPS, identify potential refinements in intervention and implementation strategies, and evaluate impact of local adaptation and fidelity on implementation success and sustainability.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Sequential Primary purpose: Other Masking/blinding: None

Interventions / Regimen

  • Behavioral: Asthma CHAMPS full program — Full program includes (1) education for staff, students, and caregivers (2) environmental education and intervention (3) asthma care coordination (4) resources
  • Behavioral: Asthma CHAMPS Wait List Control — Stepped wedge design

Primary Outcomes

  • Asthma-related absences (4 years)
  • Emergency Department (ED) utilization for asthma by children (4 years)
  • Hospitalization for asthma by children (4 years)
  • Oral corticosteroid steroid prescription for asthma by children (4 years)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-11-27
Completion: 2027-06-30
Eligibility
Age: Not reported
Sex: ALL
Volunteers: true
Enrollment: 1000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Johns Hopkins University
Collaborators: Baltimore City Public Schools, Baltimore City Health Department, National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Michelle N Ealin, PhD (PRINCIPAL_INVESTIGATOR) - JHU
  • Meredith McCormack, MD MHS (PRINCIPAL_INVESTIGATOR) - JHU
Contact Information
Study Contact:
Michelle N Eakin, PhD
410-550-0487
meakin1@jhmi.edu
Meredith McCormack, MD MHS
mmccor16@jhmi.edu
Christopher Wohn
Baltimore City Public Schools
Interventions
  • Behavioral: Asthma CHAMPS full program — Full program includes (1) education for staff, students, and caregivers (2) environmental education and intervention (3) asthma care coordination (4) resources
  • Behavioral: Asthma CHAMPS Wait List Control — Stepped wedge design
Study Locations (1 sites)
Baltimore City Public Schools, Baltimore, Maryland 21202 United States
Eligibility Criteria
Adult Inclusion Criteria: * Aged 18 or older * Current caregiver of child with asthma or staff member at a Baltimore City K-8 Public School in Asthma CHAMPS Exclusion Criteria: * Unwilling to consent Children with asthma Inclusion Criteria: * Asthma diagnosis * Currently enrolled in Baltimore City K-8 Public School participating in Asthma CHAMPS Exclusion Criteria: * Unwilling to provide assent

Nutrition for Asthmatics

NCT06151405
Recruiting
Conditions Asthma
Phase NA
Enrollment 15
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-10
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

Determine to what extent three distinct dietary approaches improve asthma control and lung function.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Crossover Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Other: DGA Diet — A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans (DGA) Including: * A variety of vegetables and fruits * Grains, at least half of which are whole grains * Fat-free or low-fat dairy * A variety of protein foods, including seafood, lean meats and poultry, eggs, legumes, nuts, and seeds * This healthy eating pattern also limits saturated fats and trans fats, added sugars, and sodium.
  • Other: MCT Diet — A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
  • Other: KETO Diet — A fully provisioned isocaloric, isonitrogenous ketogenic study diet.

Primary Outcomes

  • Asthma Control (Baseline)
  • Asthma Control (After 7 days on Diet#1)
  • Asthma Control (After 7 days on Diet#2)
  • Asthma Control (After 7 days on Diet#3)
  • Lung Function (Baseline)
  • Lung Function (After 7 days on Diet#1)
  • Lung Function (After 7 days on Diet#2)
  • Lung Function (After 7 days on Diet#3)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-07-17
Completion: 2027-03-01
Eligibility
Age: 18 Years – 65 Years
Sex: ALL
Volunteers: false
Enrollment: 15 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Pennington Biomedical Research Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Jacob T Mey, PhD, RD (PRINCIPAL_INVESTIGATOR) - Pennington Biomedical Research Center
Contact Information
Study Contact:
Jacob T Mey, PhD, RD
225-763-2644
jacob.mey@pbrc.edu
John P Kirwan, PhD
225-763-2644
john.kirwan@pbrc.edu
Executive Director
225-763-2513
Pennington Biomedical Research Center
Interventions
  • Other: DGA Diet — A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans (DGA) Including: * A variety of vegetables and fruits * Grains, at least half of which are whole grains * Fat-free or low-fat dairy * A variety of protein foods, including seafood, lean meats and poultry, eggs, legumes, nuts, and seeds * This healthy eating pattern also limits saturated fats and trans fats, added sugars, and sodium.
  • Other: MCT Diet — A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
  • Other: KETO Diet — A fully provisioned isocaloric, isonitrogenous ketogenic study diet.
Study Locations (1 sites)
Pennington Biomedical Research Center, Baton Rouge, Louisiana 70808 United States
Eligibility Criteria
Inclusion Criteria: * Age: 18-65 years * BMI: 18.5 - 29.99 kg/m2 * asthma diagnosed by medical specialist (confirmed in medical history) * partly controlled or uncontrolled asthma by Asthma Control Test score ≤22 * owns a device compatible with ZEPHYRx platform * stable asthma medication use (no change in the past 2 months). Exclusion Criteria: * Diabetes or using diabetes medications that may lower blood glucose levels * point of care fasting blood glucose ≥126 mg/dl or triglycerides ≥400 mg/dl * current smoking or smoking history of greater than 10 pack-years * other significant respiratory or cardiac disease or the presence of clinically important comorbidities, e.g., COPD, renal failure, liver disease; uncontrolled hypertension defined as systolic blood pressure ≥160 mm/Hg, or diastolic blood pressure ≥100 mm/Hg * pregnant or nursing women * food preferences or allergies inconsistent with study diet capabilities * noncompliance with lead-in period requirements.

RIG 101 Trial in Healthy Adults and Adults With Asthma

NCT07488897
Recruiting
Conditions Healthy Adult Participants, Asthma Exace...
Phase PHASE1, PHASE2
Enrollment 82
Locations 2 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-10
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Study Details Design, interventions, and primary outcomes

About This Study

Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy

Design

Study type: Interventional Phases: Phase1, Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Drug: RIG-101 — Single, and repeat escalating intranasal administrations of RIG-101
  • Other: Placebo — Single and repeat Intranasal administrations

Primary Outcomes

  • Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1-35)
  • Systolic/Diastolic blood pressure (Day 0 - 35)
  • Physical examinations (Day 0 -35)
  • Nasal examinations (Day 0 - 35)
  • Spirometry (FEV₁ and FVC) (Day 0-35)
  • Triplicate 12-lead ECGs and single 12-lead ECGs (Day 0 - 35)
  • Safety laboratory testing-haematology (Day 0 - 35)
  • Safety laboratory testing-Serum Chemistry (Day 0- 35)
Interested in this trial?
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Recruiting
Start Date: 2026-02-09
Completion: 2027-02
Eligibility
Age: 18 Years – 65 Years
Sex: ALL
Volunteers: true
Enrollment: 82 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: RIGImmune Inc.
Collaborators: Virtus Respiratory Research, Medicines Evaluation Unit Ltd
Contact Information
Study Contact:
VirTus Team
02075545858
volunteer@virtus-rr.com
Virtus Respiratory Research Ltd
MEU team
0800 655 6553
recruitment@meu.org
Medicines Evaluation Unit
Interventions
  • Drug: RIG-101 — Single, and repeat escalating intranasal administrations of RIG-101
  • Other: Placebo — Single and repeat Intranasal administrations
Study Locations (2 sites)
Virtus Respiratory Research Ltd, London, United Kingdom
Medicines Evaluation Unit, Manchester, M23 9QZ United Kingdom
Eligibility Criteria
Inclusion Criteria: Participants must meet all the following inclusion criteria to be eligible to participate in the trial. * Participants must have a written informed consent obtained prior to any trial related procedure * Male and female participants aged between 18 to 65 years inclusive, at the time of informed consent. * Participants must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time of screening, as judged by the Investigator. Additional Inclusion Criteria for Healthy Participants \- Participants must have a pre-bronchodilator FEV1 ≥80% predicted (using GLI Global predicted values17) and an FEV1 / FVC ratio of \>70% absolute at screening. Additional Inclusion Criteria for Participants with Asthma * Participants must have a clinical diagnosis of asthma. * Participants must have either a positive skin prick test with a wheal diameter of ≥3mm greater than control test at 15 minutes, and/or a blood eosinophil count of \> 200 cells / µL and/or a FeNO level of \> 25 ppb at screening. * Participants must have a pre-bronchodilator FEV1 ≥65% predicted at screening * Participants must be using SABA alone or inhaled corticosteroids (ICS) with SABA or ICS with formoterol as reliever therapy, AND/OR regular use of low to mid-dose ICS with or without LABA at a stable dose for at least 3 months prior to randomization to control their asthma. Part B only * Participants must have an ACQ-6 score of \> 0.75 at screening. * Participants must have a history of asthma worsening in the previous 2 years, in response to a cold or respiratory infection, as confirmed by the participant. * Participants must demonstrate seronegativity to RV-A16 Exclusion Criteria: Exclusion Criteria for all Participants * History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the participant's safety during the clinical trial, expose the participant to undue risk or interfere with the participants ability to successfully conduct the trial, as judged by the Investigator. * Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the trial at time of screening. * Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first administration of IMP and/or history of being hospitalized due to epistaxis on any previous occasion. * Any nasal or sinus surgery within 3 months of the first administration of IMP * Any signs of upper respiratory tract infection within 6 weeks of screening or prior to first administration of IMP * Current or previous use of tobacco, nicotine products or e-cigarettes in the past 6 months prior to screening. * Smoking history of \> 5 pack years. Additional Exclusion Criteria for Participants with Asthma * Any asthma exacerbation on their current asthma controller medication requiring oral/systemic corticosteroids within 8 weeks of randomization, or that resulted in overnight hospitalization requiring additional treatment for asthma within 3 months of randomization. * Difficult-to-treat or severe asthma requiring the maintenance use of add-on biologic Type 2 targeted treatments including anti-Immunoglobulin E, anti-IL4 receptor, anti-IL5, anti-IL5 receptor, and anti-Thymic Stromal Lymphopoietin * History of life-threatening asthma, defined as any asthma episode that required admission to a high-dependency or intensive therapy unit. * Individuals with close contact to at risk patient groups

Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study

NCT02947945
Recruiting
Conditions Asthma
Phase PHASE2
Enrollment 10
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-10
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Study Details Design, interventions, and primary outcomes

About This Study

Reslizumab is a type of medicine called a monoclonal antibody that is made in the research clinic; it works by blocking a specific protein in the body called interleukin-5. The study medicine, reslizumab, is not yet approved for doctors to treat patients with EGPA. It is considered an experimental drug in this study.

Design

Study type: Interventional Phases: Phase2 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Reslizumab — All subjects will receive Reslizumab

Primary Outcomes

  • Document the safety of reslizumab therapy in patients with EGPA (up to 12 months)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2017-09-12
Completion: 2018-12
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 10 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National Jewish Health
Collaborators: Teva Pharmaceuticals USA
Principal Investigators:
  • Michael Wechsler, MD (PRINCIPAL_INVESTIGATOR) - National Jewish Health
Contact Information
Study Contact:
Michael Wechsler, MD
303-398-1443
wechslerm@njhealth.org
Juno Pak
303-398-1132
pakj@njhealth.org
Michael Wechsler, MD
303-398-1085
wechslerm@njhealth.org
National Jewish Health
Interventions
  • Drug: Reslizumab — All subjects will receive Reslizumab
Study Locations (1 sites)
National Jewish Health, Denver, Colorado 80206 United States
Eligibility Criteria
Inclusion Criteria: * Informed Consent: Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials. * Gender and Age: Male or female subjects \>18 years old * EGPA diagnosis: subjects who have been diagnosed with EGPA for at least 6 months based on the history or presence of: asthma plus eosinophilia (\>1.0x109/L and/or \>10% of leucocytes) plus at least two of the following additional features of EGPA: * A biopsy showing histopathological evidence of eosinophilic vasculitis, or perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation; * Neuropathy, mono or poly (motor deficit or nerve conduction abnormality); * Pulmonary infiltrates, non-fixed; * Sino-nasal abnormality; * Cardiomyopathy (established by echocardiography or MRI); * Glomerulonephritis (haematuria, red cell casts, proteinuria); * Alveolar haemorrhage (by bronchoalveolar lavage); * Palpable purpura; * ANCA positive (MPO or PR3). * Subjects who have received a cyclophosphamide (CYC) induction regimen may be included a minimum of 2 weeks after the last dose of daily oral CYC, or 3 weeks after the last dose of pulsed IV CYC prior to visit 1, if their total WBC is ≥4x109/L prior to visit 1. * Subjects who have received a methotrexate, azathioprine, or mycophenolate mofetil induction regimen may be included if on a stable dose for at least 4 weeks prior to visit 1. * Corticosteroid therapy: Subject must be on a stable dose of oral prednisolone or prednisone of ≥5 mg/day for at least 4 weeks prior to visit 1. * Immunosuppressive therapy: If receiving immunosuppressive therapy (including methotrexate, azathioprine, or mycophenolate mofetil, but excluding restricted medications below) the dosage must be stable for the 4 weeks prior to visit 1 and during the study (dose reductions for safety reasons will be permitted). * Female subjects: To be eligible for entry into the study, females of childbearing potential (FCBP) must commit to consistent and correct use of an acceptable method of birth control beginning with consent, for the duration of the trial. Exclusion Criteria: * Hypereosinophilic Syndrome * Wegener's Granulomatosis * Malignancy * Parasitic disease * Pregnant or nursing * If female and of child-bearing potential, must have negative pregnancy test and must adhere to acceptable method of contraception (with \<1% failure rate) during the study and for four months after the study. * Any other medical illness that precludes study involvement * Patients who are currently receiving or have previously received reslizumab or any other type of anti-interleukin therapy (i.e. mepolizumab, lebrikizumab etc.) within the last three months. * Taking cyclophosphamide * Any patients with a known hypersensitivity to reslizumab or any of its excipients

International Severe Asthma Registry_Hong Kong

NCT07524543
Recruiting
Conditions Asthma
Phase Not Applicable
Enrollment 500
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-10
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

To ensure the care of people with severe asthma continues to improve, it is essential we have detailed information on the health and treatment of as many people with the condition as possible. The purpose of the registry is to gather this information and track the progress of patients and how well they are responding to treatment. Medical research using data from the registry will provide a better understanding of asthma and help to develop and improve the care and treatment for patients with asthma. Detailed protocol can be referred to the reference in this trial registration (International severe asthma registry \[ISAR\]: protocol for a global registry).

Design

Study type: Observational Observational model: Case Only Time perspective: Prospective

Primary Outcomes

  • Asthma exacerbations (Every year up to 10 years)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-11-01
Completion: 2036-12-31
Eligibility
Age: 18 Years – 120 Years
Sex: ALL
Volunteers: false
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chinese University of Hong Kong
Contact Information
Study Contact:
Wai San Fanny Ko, MD
+852 35053133
fannyko@cuhk.edu.hk
David Shu Cheong Hui, MD
+852 35053133
dschui@cuhk.edu.hk
Fanny Wai San Ko, MD
+852 35053133
fannyko@cuhk.edu.hk
The Chinese University of Hong Kong
Interventions
N/A
Study Locations (1 sites)
The Chinese University of Hong Kong, Hong Kong, Hong Kong
Eligibility Criteria
Inclusion Criteria: Patient with severe asthma with age 18 or over will be recruited. Exclusion Criteria: Patients who cannot provide written consent

Impact of Help-Seeking Behaviors on Allergic Rhinitis and Mental Health: A Longitudinal Study

NCT06623799
Recruiting
Conditions Mental Health Conditions, Allergic
Phase Not Applicable
Enrollment 200000
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-10
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This study explores how help-seeking behaviors for both emotional well-being and allergies impact the management of allergic rhinitis, asthma, and mental health symptoms, including anxiety and depression. The research involves a retrospective and longitudinal analysis of patients who sought treatment for allergic rhinitis and mental health concerns. The goal is to highlight the importance of integrating mental health care into allergy treatment plans to improve overall patient outcomes.

Design

Study type: Observational Observational model: Ecologic Or Community Time perspective: Cross Sectional

Primary Outcomes

  • Change in Allergic Rhinitis Symptom Severity (SNOT-22 Score) (baseline and yearly follow-up for up to 5 years)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2020-01-01
Completion: 2027-01-25
Eligibility
Age: 4 Years – 100 Years
Sex: ALL
Volunteers: true
Enrollment: 200000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: QHSLab, Inc.
Contact Information
Study Contact:
Marcos A Sanchez-Gonzalez, MD, PhD
850-559-7676
masanchez@qhslab.com
Troy Grogan
troy.grogan@usaqcorp.com
Marcos A Sanchez-Gonzalez, MD, PhD
8505597676
masanchez@qhslab.com
QHSLab
Interventions
N/A
Study Locations (1 sites)
QHSLab, West Palm Beach, Florida 33407 United States
Eligibility Criteria
Inclusion Criteria: Adults (aged 18 years or older) Patients actively receiving care in a primary care setting. Patients who have provided informed consent for their health data to be included in the research repository. Exclusion Criteria: Patients who have not provided informed consent for their health data to be included in the research repository. Patients diagnosed with chronic conditions outside the scope of allergic rhinitis, asthma, or mental health conditions (anxiety, depression). Patients with severe mental health disorders or comorbidities that are unrelated to the conditions of interest (e.g., schizophrenia, bipolar disorder, etc.).

An Online Ecoaching RCT Intervention for Carers: Enhancing Wellbeing and Resilience Through Self-Help Strategies

NCT06604481
Recruiting
Conditions Caregiver Burden, Self Efficacy, Quality...
Phase NA
Enrollment 232
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-10
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this three-armed, double-blind randomized controlled trial (RCT) is to compare the effectiveness of an online self-help eCoaching intervention designed for caregivers. The main questions it aims to answer are: What is the impact of the online self-help eCoaching intervention on the well-being, depressive symptoms, and self-efficacy of participants? Researchers will compare the results between the intervention groups and the control group to see if participants in the intervention groups have lower distress, burden and higher accuracy.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Supportive Care Masking/blinding: Double

Interventions / Regimen

  • Behavioral: eCoaching for Caregivers of Older Adults — The experimental group receives an online intervention based on Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, lifestyle intervention, and effective communication skills. This program is designed to operate individually on an e-platform. It consists of 6 weekly sessions, each lasting for less than 90 minutes. The content of the sessions focuses on teaching caregivers CBT techniques, lifestyle modifications to improve caregiving experiences, and effective communication strategies. In between each session, participants are assigned home practices to reinforce the skills learned further. All content will be included.
  • Behavioral: eCoaching (need specific) for Caregivers of Older Adults — The experimental group receives an online intervention based on Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, lifestyle intervention, and effective communication skills as in eCoaching I. However, eCoaching II will include content specified to carer's specific need.
  • Behavioral: Control Intervention for Caregivers of Older Adults — The control group attends 6 weekly online sessions that primarily provide educational information about lifestyle factors and communication. These sessions aim to enhance the control group's knowledge and understanding of the factors that impact caregiving. Each session in the control group also lasts for 90 minutes. The focus of these activities will be on building practical caregiving skills and promoting overall well-being, rather than targeting any particular psychological or mental health-related factors directly.

Primary Outcomes

  • Patient Health Questionnaire (PHQ-9) (3 months)
  • Carers Multidimensional Need Assessment Tool (3 months)
  • Generalised Anxiety Disorder (GAD-7) (3 months)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-04-30
Completion: 2026-09
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: true
Enrollment: 232 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The University of Hong Kong
Principal Investigators:
  • Vivian Lou, PhD (PRINCIPAL_INVESTIGATOR) - Sau Po Center on Ageing, HKU
Contact Information
Study Contact:
Vivian Lou, PhD
3917 4835
wlou@hku.hk
Interventions
  • Behavioral: eCoaching for Caregivers of Older Adults — The experimental group receives an online intervention based on Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, lifestyle intervention, and effective communication skills. This program is designed to operate individually on an e-platform. It consists of 6 weekly sessions, each lasting for less than 90 minutes. The content of the sessions focuses on teaching caregivers CBT techniques, lifestyle modifications to improve caregiving experiences, and effective communication strategies. In between each session, participants are assigned home practices to reinforce the skills learned further. All content will be included.
  • Behavioral: eCoaching (need specific) for Caregivers of Older Adults — The experimental group receives an online intervention based on Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, lifestyle intervention, and effective communication skills as in eCoaching I. However, eCoaching II will include content specified to carer's specific need.
  • Behavioral: Control Intervention for Caregivers of Older Adults — The control group attends 6 weekly online sessions that primarily provide educational information about lifestyle factors and communication. These sessions aim to enhance the control group's knowledge and understanding of the factors that impact caregiving. Each session in the control group also lasts for 90 minutes. The focus of these activities will be on building practical caregiving skills and promoting overall well-being, rather than targeting any particular psychological or mental health-related factors directly.
Study Locations (1 sites)
Sau Po Center on Ageing HKU, Hong Kong, Hong Kong
Eligibility Criteria
Inclusion Criteria: * being an adult aged 18 or above with a family member aged 60 or above requiring caregiving, providing at least 6 hours of care per week * self-identifying as a family caregiver * living in Hong Kong * able to communicate with the interventionist * voluntary participation * reporting mild risk need in Carer Need Screening tool Exclusion Criteria: * having diagnosed Alzheimer's or other dementia * experiencing acute health conditions that hinder caregiving support or intervention participation