IMPACT Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised Controlled Trial to Evaluate the Effectiveness of a Multidisciplinary Team Intervention on Glycaemic Control for Disadvantaged Type 2 Diabetes Patients in France.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: IMPACT intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with type 2 diabetes Inclusion HbA1c > 7.5% Live in Hauts de Chambéry, Biollay or Renaudie district Be able to give written consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>IMPACT intervention | Behavioral: IMPACT intervention<br>* 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 (without condition or limit). 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 patient with his health administrative procedures. This intervention lasts 6 months.<br>|
| No Intervention: Control group<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Change in glycated haemoglobin (HbA1c) | From baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Change in glycated haemoglobin (HbA1c) | From baseline to 3 months | 
| Weight | Change in weight | At Months 3 and 6 from baseline | 
| Body mass index | Change in body mass index | At Months 3 and 6 from baseline | 
| Body fat mass (Bioelectrical impedance analysis) | Change in body fat mass | At Months 3 and 6 from baseline | 
| Body fat percentage (Bioelectrical impedance analysis) | Change in body fat percentage | At Months 3 and 6 from baseline | 
| Muscle mass (Bioelectrical impedance analysis) | Change in muscle mass. | At Months 3 and 6 from baseline | 
| Lipids - HDL cholesterol | Change in HDL cholesterol | From baseline to 6 months | 
| Lipids - LDL cholesterol | Change in LDL cholesterol | From baseline to 6 months | 
| Lipids - triglycerides | Change in triglycerides | From baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary health care, patient-centered care, poverty areas, vulnerable populations, Glycated Hemoglobin A