Continuous Care Intervention in Primary Care to Improve Type 2 Diabetes Control in Terres de l'Ebre, Catalonia
Recruiting · NCT07124923 · Interventional (participants receive a specific treatment) · Lead sponsor: Institut Investigacio Sanitaria Pere Virgili
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
12 locations listed.
- Abs Amposta - Amposta, Tarragona, Spain
- Abs Deltebre - Deltebre, Tarragona, Spain
- Abs Ametlla-Perelló - El Perelló, Tarragona, Spain
- ABS FLIX - Flix, Tarragona, Spain
- Abs Gandesa - Gandesa, Tarragona, Spain
- Abs Ampolla-Aldea - L'Ampolla, Tarragona, Spain
- Abs Mora La Nova - Móra la Nova, Tarragona, Spain
- Abs La Ràpita-Alcanar - Sant Carles de la Ràpita, Tarragona, Spain
- Abs Tortosa Est - Tortosa, Tarragona, Spain
- Abs Tortosa Oest - Tortosa, Tarragona, Spain
- Hospital de Tortosa Verge de la Cinta - Tortosa, Tarragona, Spain
- Abs Ulldecona - Ulldecona, Tarragona, Spain