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

NCT07124923 | Recruiting

• 2 other identifiers: 009/20242024 DI 00039
• Study Type: interventional
• Target: 7,792
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Diabetes Mellitus Type 2

Keywords

HbA1c; Primary Care; Continuity of Care; Training

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Evaluate the percentage improvement in HbA1c levels in relation to healthcare professionals' attendance at training sessions.

  At enrollment, 6, 12, and 24 months after enrollment.

Secondary Outcomes (12)

• Change in total cholesterol and LDL cholesterol

  At enrollment, 6, 12, and 24 months after enrollment.

• Change in systolic and diastolic blood pressure

  At enrollment, 6, 12, and 24 months after enrollment.

• Change in smoking status

  At enrollment, 6, 12, and 24 months after enrollment.

• Change in Body Mass Index (BMI)

  At enrollment, 6, 12, and 24 months after enrollment.

• Percentage of participants adherent to screening protocol for T2DM complications

  At enrollment, 6, 12, and 24 months after enrollment.

Study Arms (2)

Continuity-of-Care Training for Primary Care Professionals

EXPERIMENTAL

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.

Other: Continuity-of-Care intervention

Usual Care (No Continuity-of-Care Training)

NO INTERVENTION

Primary care professionals provide care according to current local standard practices without receiving specific training on continuity-of-care strategies.

Interventions

Continuity-of-Care intervention OTHER

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.

Continuity-of-Care Training for Primary Care Professionals

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of type 1 diabetes mellitus (T1DM)
• 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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator
• Institut Investigacio Sanitaria Pere Virgili: lead
• Institut Catala de Salut: collaborator

Study Sites (12)

Abs Amposta

Amposta, Tarragona, 43870, Spain

RECRUITING

Abs Deltebre

Deltebre, Tarragona, 43580, Spain

RECRUITING

Abs Ametlla-Perelló

El Perelló, Tarragona, 43860, Spain

RECRUITING

ABS FLIX

Flix, Tarragona, 43750, Spain

RECRUITING

Abs Gandesa

Gandesa, Tarragona, 43780, Spain

RECRUITING

Abs Ampolla-Aldea

L'Ampolla, Tarragona, 43895, Spain

RECRUITING

Abs Mora La Nova

Móra la Nova, Tarragona, 43770, Spain

RECRUITING

Abs La Ràpita-Alcanar

Sant Carles de la Ràpita, Tarragona, 43540, Spain

RECRUITING

Abs Tortosa Est

Tortosa, Tarragona, 43500, Spain

RECRUITING

Abs Tortosa Oest

Tortosa, Tarragona, 43500, Spain

RECRUITING

Hospital de Tortosa Verge de la Cinta

Tortosa, Tarragona, 43500, Spain

RECRUITING

Abs Ulldecona

Ulldecona, Tarragona, 43550, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Marcela Miret Llauradó, MD

  Catalan Institute of Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcela Miret Llauradó, MD

CONTACT

+0034977519100; mmiretl.ebre.ics@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will maintain blinding for participating patients, the data manager, the principal investigator, the statistician and the rest of the research team members. However, the primary care professionals who will receive the intervention, the trainers, those responsible for data extraction and the members of the training committee will not be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 15, 2025
• Study Start: July 20, 2025
• Primary Completion: January 20, 2026
• Study Completion (Estimated): July 20, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (12)