RecruitingNot ApplicableNCT07124923

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

Effectiveness of a Continuous Care Intervention by the Endocrinology and Nutrition Service in Primary Care to Improve the Control of Type 2 Diabetes Mellitus in Terres de l'Ebre, Catalonia


Sponsor

Institut Investigacio Sanitaria Pere Virgili

Enrollment

7,792 participants

Start Date

Jul 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a more personalized and continuous care approach in primary care clinics to help adults with type 2 diabetes manage their blood sugar more effectively. You may be eligible if: - You are 18 years or older (but under 90) - You have been diagnosed with type 2 diabetes for at least 12 months - Your diabetes care is managed through a primary care clinic using the eCAP health records system You may NOT be eligible if: - You have type 1 diabetes - Your diabetes is currently being managed by a specialist (not a primary care doctor) - You are currently taking steroid medicines by mouth or injection long-term - You have an active cancer diagnosis - You have gestational diabetes (pregnancy-related diabetes) - You are currently pregnant or breastfeeding - You have a life expectancy of less than 1 year due to advanced illness - You are classified as a complex chronic patient - You have been diagnosed with dementia - You live in a care facility or nursing home - You have severe mental illness (such as psychosis, bipolar disorder, or major depression) - You have had a kidney transplant or are on dialysis - You have a history of serious alcohol or drug misuse Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERContinuity-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.


Locations(12)

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

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NCT07124923


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