IMPACT Intervention
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: IMPACT intervention
- Registration Number
- NCT04616053
- Lead Sponsor
- Pole de Sante Chambery Nord
- Brief Summary
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.
- Detailed Description
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.
Analysis : 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. Study groups, districts, time, group-time interaction and district-group interaction will be included as fixed effects. The model will include patients as a random effect. Sub-group analysis will be made with baseline HbA1c, sex, age, Epices score (French precarity score) and diabetes duration. The robustness of the model will be tested by replacing missing data with multiple imputation methods. The same statistical modelling approach will be used for the secondary outcomes.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 140
- Patients with type 2 diabetes
- Inclusion HbA1c > 7.5%
- Live in Hauts de Chambéry, Biollay or Renaudie district
- Be able to give written consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group IMPACT intervention IMPACT intervention
- Primary Outcome Measures
Name Time Method HbA1c From baseline to 6 months Change in glycated haemoglobin (HbA1c)
- Secondary Outcome Measures
Name Time Method Body mass index At Months 3 and 6 from baseline Change in body mass index
Body fat percentage (Bioelectrical impedance analysis) At Months 3 and 6 from baseline Change in body fat percentage
Lipids - LDL cholesterol From baseline to 6 months Change in LDL cholesterol
HbA1c From baseline to 3 months Change in glycated haemoglobin (HbA1c)
Body fat mass (Bioelectrical impedance analysis) At Months 3 and 6 from baseline Change in body fat mass
Muscle mass (Bioelectrical impedance analysis) At Months 3 and 6 from baseline Change in muscle mass.
Lipids - triglycerides From baseline to 6 months Change in triglycerides
Lipids - HDL cholesterol From baseline to 6 months Change in HDL cholesterol
Weight At Months 3 and 6 from baseline Change in weight