Actively Recruiting
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
Led by Institut Investigacio Sanitaria Pere Virgili · Updated on 2025-09-08
7792
Participants Needed
12
Research Sites
78 weeks
Total Duration
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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
Researchers are evaluating a continuity of care intervention aimed at improving metabolic control in adults with type 2 diabetes mellitus (T2DM) in the Terres de l'Ebre health region. This randomized, parallel-group clinical trial is led by the Endocrinology Service at Hospital de Tortosa Verge de la Cinta and focuses on training primary care professionals through structured, multidisciplinary education and feedback. The study addresses challenges in managing T2DM including glycemic control and cardiovascular risk, with HbA1c as the primary marker. The intervention involves onsite training sessions delivered by endocrinologists and nurse educators to primary care physicians and nurses at selected centers. Training consists of six modules combining theoretical and practical content related to diabetes management, cardiovascular risk reduction, and diabetic foot care. These sessions occur biweekly over one year from July 2025 to July 2026, with each participating center receiving 15 sessions. Centers are randomized to either receive this training or continue usual care without the specific continuity-of-care training. Participants with T2DM will be assessed at baseline, 6, 12, and 24 months for HbA1c and secondary health outcomes like cholesterol levels, blood pressure, BMI, and adherence to screening protocols. The study also collects professional feedback through focus groups before and after the intervention to understand barriers and facilitators. Data are anonymized, and the study aims to provide evidence on the effectiveness of multidisciplinary care continuity in a primary care setting over a two-year follow-up period.
CONDITIONS
Brief Title
Continuous Care Intervention in Primary Care to Improve Type 2 Diabetes Control in Terres de l'Ebre, Catalonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 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
You will not qualify if you...
- Diagnosis of type 1 diabetes mellitus
- Type 2 diabetes managed by a specialist at the time of inclusion
- Current treatment with systemic corticosteroids
- Active malignancy (neoplasia)
- Gestational diabetes
- Pregnancy or breastfeeding
- Advanced chronic disease with life expectancy less than 1 year (MACA)
- Complex chronic patients (CCP)
- Diagnosis of dementia
- Institutionalized patients or residents in social healthcare facilities
- Age under 18 years
- Age over 90 years
- Severe psychiatric illness (e.g., psychosis, bipolar disorder, major depression)
- History of kidney transplant
- Undergoing dialysis
- History of alcohol or drug abuse
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants receive a structured, multidisciplinary training and feedback program delivered by endocrinologists and nurse educators to primary care physicians and nurses to improve management of type 2 diabetes.
Biweekly sessions totaling 15 per year at each primary care center
Duration - 24 months
Participants’ health indicators and clinical outcomes are monitored and recorded at baseline, 6, 12, and 24 months after enrollment to assess the effectiveness of the intervention.
4 visits (baseline, 6, 12, and 24 months)
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
Research Team
M
Marcela Miret Llauradó, MD
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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