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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 7,792
- 试验地点
- 24
- 主要终点
- HbA1c
研究概览
简要总结
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.
详细描述
T2DM is a highly prevalent chronic disease, accounting for approximately 90% of all diabetes cases, and is primarily managed in the primary care setting. The complexity of optimizing metabolic control in T2DM has increased, as current guidelines recommend a multifactorial approach that addresses not only glycemic control but also cardiovascular risk and multimorbidity. Glycosylated hemoglobin (HbA1c) remains the principal marker for assessing glycemic control and predicting diabetes-related complications.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Diagnosis of type 1 diabetes mellitus (T1DM)
- •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
结局指标
主要结局
HbA1c
时间窗: At enrollment, 6, 12, and 24 months after enrollment.
Evaluate the percentage improvement in HbA1c levels in relation to healthcare professionals' attendance at training sessions.
次要结局
- 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.)
- Change in total cholesterol and LDL cholesterol(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.)
- Referrals to the Diabetic Foot Unit(At enrollment, 6, 12, and 24 months after enrollment.)
- Medication changes(At enrollment, 6, 12, and 24 months after enrollment.)
- Professional perceptions of relevance, feasibility and impact of the Continuity-of-Care intervention(Pre-intervention and 1 month post-intervention)
- Professional experiences with implementing the Continuity-of-Care intervention, including perceived barriers and facilitators(Pre-intervention and 1 month post-intervention.)
- 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.)
- Medication changes(At enrollment, 6, 12, and 24 months after enrollment.)
- Number of patient visits to primary care(At enrollment, 6, 12, and 24 months after enrollment.)
- Professional perceptions of relevance, feasibility and impact of the Continuity-of-Care intervention(Pre-intervention and 1 month post-intervention)
- Professional experiences with implementing the Continuity-of-Care intervention, including perceived barriers and facilitators(Pre-intervention and 1 month post-intervention.)
- Percentage of participants adherent to screening protocol for T2DM complications(At enrollment, 6, 12, and 24 months after enrollment.)
- Referrals to the Diabetic Foot Unit(At enrollment, 6, 12, and 24 months after enrollment.)
- Emergency assistance for metabolic decompensations(At enrollment, 6, 12, and 24 months after enrollment.)
- Number of hospital referrals from primary care(At enrollment, 6, 12, and 24 months after enrollment.)