Continuous Care Intervention in Primary Care to Improve Type 2 Diabetes Control in Terres de l'Ebre, Catalonia
NCT ID: NCT07124923
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
7792 participants
INTERVENTIONAL
2025-07-20
2027-07-20
Brief Summary
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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.
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Detailed Description
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Despite the availability of evidence-based clinical practice guidelines, their implementation in routine care is often suboptimal due to factors such as limited time, resources, clinical inertia, and challenges with patient adherence. Interventions targeting healthcare professionals and organizational processes-such as structured training, audit and feedback, and system-level changes-have shown promise in improving metabolic outcomes, particularly among patients with suboptimal glycemic control.
This study is a randomized, parallel-group clinical trial designed to evaluate the effectiveness of a continuity of care intervention led by the Endocrinology Service at HTVC, in collaboration with primary care centers in the Terres de l'Ebre health region. Primary care centers will be randomized to either the intervention or control group.
The intervention consists of structured, multidisciplinary training and feedback provided by endocrinologists and nurse educators to primary care physicians and nurses. Training sessions are delivered in modules that combine theoretical and practical content, with a focus on up-to-date diabetes management strategies and the needs of each primary care center. The endocrinology team includes endocrinologists, nurse educators, and a specialist nurse from the Diabetic Foot Unit. Training will be delivered onsite at intervention centers in scheduled sessions over a one-year period.
A qualitative component is integrated into the study, involving focus groups with participating primary care professionals before and after the intervention. This aims to gather insights on professional perspectives, identify barriers and facilitators, and inform the adaptation and future implementation of the intervention.
The primary outcome is improvement in HbA1c, with secondary outcomes including additional patient health indicators, professional knowledge and engagement, and organizational variables. Data collection will occur at baseline, 6, 12, and 24 months. All data will be anonymized to ensure confidentiality.
This study aims to provide evidence on the effectiveness of a multidisciplinary, continuity of care intervention in improving metabolic control for adults with T2DM in a real-world primary care setting.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Continuity-of-Care Training for Primary Care Professionals
A parallel-group randomized clinical trial will be conducted in 11 primary care centers of the Terres de l'Ebre area (Catalan Health Institute). Randomization was performed by the data extractor before pseudonymization using simple randomization (1:1 ratio), generating values 0 and 1. Centers scoring \<0.5 were assigned to the control group; those ≥0.5 to the intervention group, resulting in 5 intervention and 6 control centers.
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.
Usual Care (No Continuity-of-Care Training)
Primary care professionals provide care according to current local standard practices without receiving specific training on continuity-of-care strategies.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Institut Catala de Salut
OTHER_GOV
Institut Investigacio Sanitaria Pere Virgili
OTHER
Responsible Party
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Principal Investigators
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Marcela Miret Llauradó, MD
Role: PRINCIPAL_INVESTIGATOR
Catalan Institute of Health
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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2024 DI 00039
Identifier Type: OTHER
Identifier Source: secondary_id
009/2024
Identifier Type: -
Identifier Source: org_study_id
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