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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Spain
Abs Amposta
RECRUITING
Amposta
Abs Deltebre
RECRUITING
Deltebre
Abs Ametlla-Perelló
RECRUITING
El Perelló
ABS FLIX
RECRUITING
Flix
Abs Gandesa
RECRUITING
Gandesa
Abs Ampolla-Aldea
RECRUITING
L'ampolla
Abs Mora La Nova
RECRUITING
Móra La Nova
Abs La Ràpita-Alcanar
RECRUITING
Sant Carles De La Ràpita
Abs Tortosa Est
RECRUITING
Tortosa
Abs Tortosa Oest
RECRUITING
Tortosa
Hospital de Tortosa Verge de la Cinta
RECRUITING
Tortosa
Abs Ulldecona
RECRUITING
Ulldecona
Contact Information
Primary
Marcela Miret Llauradó, MD
mmiretl.ebre.ics@gencat.cat
+0034977519100
Time Frame
Start Date: 2025-07-20
Estimated Completion Date: 2027-07-20
Participants
Target number of participants: 7792
Treatments
Experimental: 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.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Institut Catala de Salut, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Leads: Institut Investigacio Sanitaria Pere Virgili

This content was sourced from clinicaltrials.gov