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IMPACT Intervention

NCT04616053 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2020-11-04

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

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 (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.

Sponsors & Collaborators

  • Pole de Sante Chambery Nord

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2023-09-30
Completion
2024-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04616053 on ClinicalTrials.gov