Recruiting
Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients
The goal of this study is to learn if a collaborative care intervention of pharmaco-therapy and/or cognitive behavioral therapy (CBT), delivered in a real-world setting, improves symptoms of pain, fatigue and/or depression.
ClinicalTrials.gov IDNCT06978127
PhaseNA
Enrollment424
SponsorUniversity of Pittsburgh
Age18 Years
SexALL
Conditions studied
Chronic Kidney Disease Requiring Hemodialysis
About this study
The goal of this study is to learn if a collaborative care intervention of pharmaco-therapy and/or cognitive behavioral therapy (CBT), delivered in a real-world setting, improves symptoms of pain, fatigue and/or depression.
Interventions
- Behavioral: Technology Assisted Stepped Collaborative Care — The TĀCcare 2.0 intervention will provide pharmacotherapy recommendations and/or CBT for pain, fatigue and depression. A stepped-treatment approach will be used to intensify treatment. CBT will be provided through 12 weekly telehealth sessions (done during dialysis treatment or from home) with the behavioral specialist. Booster sessions will be used to enhance the maintenance of effect following the initial intervention to complete a total 12 month intervention. A collaborative care approach will be used so that patients' symptom management will be integrated with their dialysis treatment. Throughout the study, participants will be asked to complete phone surveys about their symptoms and health.
- Other: Usual Care Arm — Participants in the Usual Care Arm will continue with their usual care.
Primary outcomes
- TĀCcare 2.0 Effectiveness evaluation/Change in fatigue (co-primary outcome) (6 months)
- TĀCcare 2.0 Effectiveness evaluation/Change in Pain Intensity (co-primary outcome) (6 months)
- TĀCcare 2.0 Effectiveness evaluation/Change in Depression (co-primary outcome) (6 months)
Eligibility information
Eligibility Criteria:
1. age 18 years or older;
2. undergoing thrice-weekly maintenance hemodialysis (HD) for \> 3 months;
3. English or Spanish speaking;
4. able to provide informed consent
Ineligibility Criteria:
1. active thought disorder, delusions or active suicidal ideation
2. active substance abuse
3. enrolled in hospice or life expectancy \< 6 months (based on clinician's judgement)
4. too ill or cognitively impaired to participate based on renal provider's judgement
5. living kidney transplant scheduled in \<3 months
6. undergoing active cancer treatment.
7. enrolled in another research study
8. plan to transition to home dialysis within 3 months
9. plan to move to another dialysis facility within 3 months
Study locations
- UNM, Albuquerque, New Mexico 87131 United States
- University of Pittsburgh, Pittsburgh, Pennsylvania 15213 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.