Améliorer La Prise En Soins Et La Qualité De Vie Des Patients Diabétiques De Type 2 (Alliance DT2)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 主要终点
- Glycated haemoglobin HbA1c (∆HbA1c)
研究概览
简要总结
The aim of this study is to obtain a better glycemic index score (decrease) by improving the care and quality of life of type 2 diabetic patients for a possible remission of diabetes.
This will be achieved through an intervention that includes a strategy for training primary care physicians and other healthcare professionals in patient therapeutic education (TPE), as well as group and/or individual TPE-related activities/tools made available to patients, funded and encouraged for individualized planning. Intervention follow-up will be carried out by means of quality-of-life questionnaires for patients who have undergone the new method, compared with patients who have received the usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed type 2 diabetes (less than 10 years)
- •Age (between 40 and 65)
排除标准
- •Significant comorbidities linked to worsening diabetes (such as renal failure, previous myocardial infarction, retinopathy, signs or symptoms of severe diabetic neuropathy or diabetic foot ulcers), severe osteoarthritis or as judged by the attending physician.
- •Pregnant or breast-feeding women
- •Persons who are unable to give signed informed consent
结局指标
主要结局
Glycated haemoglobin HbA1c (∆HbA1c)
时间窗: During 18 month
Mean change in glycated haemoglobin HbA1c (∆HbA1c)
次要结局
- Health-related quality of life (∆ EQ-5D-5L)(During 18 months)
- Cost-effectiveness analysis(At 12 and 18 months)
- Diabetes self-care behaviours measured by the Diabetes Intention, Attitude, and Behavior Questionnaire (∆ DIAB-Q)(During 18 months)
- Fat/lean body mass (∆ body composition)(During 18 months)
研究者
Minette-Joëlle Zeukeng
Principal Investigator
Réseau de soins Delta