Améliorer La Prise En Soins Et La Qualité De Vie Des Patients Diabétiques De Type 2 (Alliance DT2)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Réseau de soins Delta
- Enrollment
- 154
- Primary Endpoint
- Glycated haemoglobin HbA1c (∆HbA1c)
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with newly diagnosed type 2 diabetes (less than 10 years)
- •Age (between 40 and 65)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Glycated haemoglobin HbA1c (∆HbA1c)
Time Frame: During 18 month
Mean change in glycated haemoglobin HbA1c (∆HbA1c)
Secondary Outcomes
- 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)
Investigators
Minette-Joëlle Zeukeng
Principal Investigator
Réseau de soins Delta