Recruiting

Continuous Care Intervention in Primary Care to Improve Type 2 Diabetes Control in Terres de l'Ebre, Catalonia

ClinicalTrials.gov IDNCT07124923

PhaseNA

Enrollment7792

SponsorInstitut Investigacio Sanitaria Pere Virgili

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Diabetes Mellitus Type 2

About this study

This randomized, parallel-group clinical trial evaluates the effectiveness of a continuity of care intervention to improve metabolic control in adults with type 2 diabetes mellitus (T2DM) in the Terres de l'Ebre health region. The intervention, led by the Endocrinology Service at Hospital de Tortosa Verge de la Cinta (HTVC), involves structured, multidisciplinary training and feedback provided by endocrinologists and nurse educators to primary care professionals. Training modules combine theoretical and practical content focused on current diabetes management. Primary care centers are randomized to intervention or control arms. Eligible participants are adult patients with an active diagnosis of T2DM for at least 12 months as of January 2025, registered in the eCAP system. All primary care professionals in intervention centers participate in the training. The intervention is conducted over one year (July 2025-July 2026). Outcomes are assessed at baseline, 6, 12, and 24 months. The primary outcome is HbA1c; secondary outcomes include other health indicators, professional knowledge and engagement, and organizational variables. A qualitative component gathers professional input before and after the intervention to inform future implementation. All data are anonymized to ensure confidentiality.

Interventions

Other: Continuity-of-Care intervention — The intervention is a structured, multidisciplinary training and feedback program led by the Endocrinology Service at HTVC in collaboration with primary care centers in Terres de l'Ebre. Four endocrinologists and four nurses (three educators and one diabetic foot referent) will provide onsite training to primary care physicians and nurses. Training includes six modules with theoretical and practical components, covering T2DM management, cardiovascular risk reduction, and diabetic foot care. Sessions will be held biweekly and delivered by doctor-nurse teams rotating through the participating primary care centers from July 2025 to July 2026, with each center receiving a total of 15 sessions per year. The program also includes regular feedback to professionals on clinical performance and patient outcomes, adapting content to each center's needs. A qualitative component, involving focus groups before and after the intervention, will gather feedback and inform future implementation.

Primary outcomes

HbA1c (At enrollment, 6, 12, and 24 months after enrollment.)

Eligibility information

Inclusion Criteria: Enrollment will begin in July 2025, aligned with the initiation of training sessions for healthcare professionals (physicians and nurses). Eligible participants must: * Be adults (≥18 years old) * Have an active diagnosis of T2DM documented in the eCAP primary care electronic health record system * Have a duration of T2DM of at least 12 months as of January 2025 Exclusion Criteria: * Diagnosis of type 1 diabetes mellitus (T1DM) * T2DM managed by a specialist at the time of inclusion * Current treatment with systemic corticosteroids * Active neoplasia (malignancy) * Gestational diabetes * Pregnancy or breastfeeding * Diagnosis of MACA (advanced chronic disease with life expectancy \<1 year) * Complex chronic patients (CCP) * Diagnosis of dementia * Institutionalized patients or those residing in social healthcare facilities * Age over 90 years * Age under 18 years * Severe psychiatric illness (e.g., psychosis, bipolar disorder, major depression) * History of kidney transplant * Undergoing dialysis * History of alcohol or drug abuse

Study locations

Abs Amposta, Amposta, Tarragona 43870 Spain
Abs Deltebre, Deltebre, Tarragona 43580 Spain
Abs Ametlla-Perelló, El Perelló, Tarragona 43860 Spain
ABS FLIX, Flix, Tarragona 43750 Spain
Abs Gandesa, Gandesa, Tarragona 43780 Spain
Abs Ampolla-Aldea, L'Ampolla, Tarragona 43895 Spain
Abs Mora La Nova, Móra la Nova, Tarragona 43770 Spain
Abs La Ràpita-Alcanar, Sant Carles de la Ràpita, Tarragona 43540 Spain
Abs Tortosa Est, Tortosa, Tarragona 43500 Spain
Abs Tortosa Oest, Tortosa, Tarragona 43500 Spain

Showing 10 of 12 reported sites. See the official listing for all locations.

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.