An interventional study of IMPACT intervention in Diabetes Mellitus, Type 2, sponsored by Pole de Sante Chambery Nord. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-04.
Sponsored by Pole de Sante Chambery Nord · Not applicable, Interventional, and Treatment
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.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 140 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →This is the only study on the registry with Pole de Sante Chambery Nord as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
IMPACT intervention
Behavioral: IMPACT intervention
Usual care
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.
HbA1c
Change in glycated haemoglobin (HbA1c)
Time frame: From baseline to 6 months
HbA1c
Change in glycated haemoglobin (HbA1c)
Time frame: From baseline to 3 months
Weight
Change in weight
Time frame: At Months 3 and 6 from baseline
Body mass index
Change in body mass index
Time frame: At Months 3 and 6 from baseline
Body fat mass (Bioelectrical impedance analysis)
Change in body fat mass
Time frame: At Months 3 and 6 from baseline
Body fat percentage (Bioelectrical impedance analysis)
Change in body fat percentage
Time frame: At Months 3 and 6 from baseline
Muscle mass (Bioelectrical impedance analysis)
Change in muscle mass.
Time frame: At Months 3 and 6 from baseline
Lipids - HDL cholesterol
Change in HDL cholesterol
Time frame: From baseline to 6 months
Lipids - LDL cholesterol
Change in LDL cholesterol
Time frame: From baseline to 6 months
Lipids - triglycerides
Change in triglycerides
Time frame: From baseline to 6 months
No study locations are listed for this record.
Plan to share: Undecided
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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