Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT07124923

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

Led by Institut Investigacio Sanitaria Pere Virgili · Updated on 2025-09-08

7792

Participants Needed

12

Research Sites

104 weeks

Total Duration

On this page

Sponsors

I

Institut Investigacio Sanitaria Pere Virgili

Lead Sponsor

F

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older
  • Active diagnosis of type 2 diabetes mellitus documented in the eCAP primary care electronic health record system
  • Duration of type 2 diabetes mellitus of at least 12 months as of January 2025
Not Eligible

You will not qualify if you...

  • Diagnosis of type 1 diabetes mellitus
  • Type 2 diabetes managed by a specialist at inclusion
  • Current treatment with systemic corticosteroids
  • Active malignancy
  • Gestational diabetes
  • Pregnancy or breastfeeding
  • Advanced chronic disease with life expectancy less than 1 year (MACA)
  • Complex chronic patients (CCP)
  • Diagnosis of dementia
  • Institutionalized or residing in social healthcare facilities
  • Age under 18 years or over 90 years
  • Severe psychiatric illness such as psychosis, bipolar disorder, or major depression
  • History of kidney transplant
  • Undergoing dialysis
  • History of alcohol or drug abuse

AI-Screening

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Trial Site Locations

Total: 12 locations

1

Abs Amposta

Amposta, Tarragona, Spain, 43870

Actively Recruiting

2

Abs Deltebre

Deltebre, Tarragona, Spain, 43580

Actively Recruiting

3

Abs Ametlla-Perelló

El Perelló, Tarragona, Spain, 43860

Actively Recruiting

4

ABS FLIX

Flix, Tarragona, Spain, 43750

Actively Recruiting

5

Abs Gandesa

Gandesa, Tarragona, Spain, 43780

Actively Recruiting

6

Abs Ampolla-Aldea

L'Ampolla, Tarragona, Spain, 43895

Actively Recruiting

7

Abs Mora La Nova

Móra la Nova, Tarragona, Spain, 43770

Actively Recruiting

8

Abs La Ràpita-Alcanar

Sant Carles de la Ràpita, Tarragona, Spain, 43540

Actively Recruiting

9

Abs Tortosa Est

Tortosa, Tarragona, Spain, 43500

Actively Recruiting

10

Abs Tortosa Oest

Tortosa, Tarragona, Spain, 43500

Actively Recruiting

11

Hospital de Tortosa Verge de la Cinta

Tortosa, Tarragona, Spain, 43500

Actively Recruiting

12

Abs Ulldecona

Ulldecona, Tarragona, Spain, 43550

Actively Recruiting

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Research Team

M

Marcela Miret Llauradó, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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