A Randomised Controlled Trial to Evaluate the Effectiveness of a Multidisciplinary Team Intervention on Glycaemic Control for Disadvantaged Type 2 Diabetes Patients in France.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 主要终点
- HbA1c
研究概览
简要总结
Introduction :
The prevalence of type 2 diabetes is increasing in France, especially in deprived districts.
The Itineraires Medico-sociaux Programme d'Accompagnement sur un Territoire (IMPACT) intervention is intended for disadvantaged patients with a chronic disease (not only type 2 diabetes).
The IMPACT intervention offers coordinated and patient-centered care by a multidisciplinary team with an empowerment approach. This personalised intervention lasts 6 months.
This study aims to evaluate the effect of 6 months IMPACT intervention on glycaemic control (glycated haemoglobin - HbA1c) of patients with type 2 diabetes in deprived districts.
Method :
This will be a randomised, controlled, parallel group, multicenter, open-label trial. 140 adults with type 2 diabetes will be randomised in two arms : IMPACT intervention group (n : 70) and usual care group (n : 70). The primary outcome is change in glycated haemoglobin (HbA1c) from baseline to 6 months. The primary outcome will be analysed using a linear mixed effects model.
详细描述
This will be a randomised, controlled, parallel group, multicenter, open-label trial. Patients will be recruited among patients with type 2 diabetes referred to the IMPACT intervention.
144 patients will be randomised in two arms : IMPACT intervention group (n : 72) and usual care group (n : 72).
IMPACT intervention : a referent is assigned to the patient. A referent is a health worker (nurse, nutritionist, psychologist …). Patient builds with his referent a free care program. The patient can choose individual consultation (for example : nutrition, tabacology, psychology …) and/or collective care (for example : patient education, physical activity, relaxation …). A community health worker can help patients with his health administrative procedures.
Patients will have 3 visits. First visit (inclusion visit) : investigator collects baseline characteristics (sociodemographic data, comorbidity, treatment, diabetes complications, weight, height, body mass index, impedancemetry, HbA1c, lipids, creatinine, albuminuria/creatinuria ratio). Then the patient will be randomised.
Second visit (midpoint visit) : investigator collects weight, BMI, impedancemetry, HbA1c and adverse events Third visit (end point visit) : investigator collects weight, BMI, impedancemetry, HbA1c, lipids and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes
- •Inclusion HbA1c > 7.5%
- •Live in Hauts de Chambéry, Biollay or Renaudie district
- •Be able to give written consent
排除标准
- •Severe cognitive or psychological disorder that may affect study understanding
- •Pregnant or breastfeeding women
- •Had IMPACT intervention in the previous 24 months
- •Concurrent participation in another study
- •Concurrent participation in another diabetes educational care program
- •Life expectancy less than 6 months
结局指标
主要结局
HbA1c
时间窗: From baseline to 6 months
Change in glycated haemoglobin (HbA1c)
次要结局
- Body mass index(At Months 3 and 6 from baseline)
- Body fat percentage (Bioelectrical impedance analysis)(At Months 3 and 6 from baseline)
- Lipids - LDL cholesterol(From baseline to 6 months)
- HbA1c(From baseline to 3 months)
- Body fat mass (Bioelectrical impedance analysis)(At Months 3 and 6 from baseline)
- Muscle mass (Bioelectrical impedance analysis)(At Months 3 and 6 from baseline)
- Lipids - triglycerides(From baseline to 6 months)
- Weight(At Months 3 and 6 from baseline)
- Lipids - HDL cholesterol(From baseline to 6 months)