IMPACT Intervention
A Randomised Controlled Trial to Evaluate the Effectiveness of a Multidisciplinary Team Intervention on Glycaemic Control for Disadvantaged Type 2 Diabetes Patients in France.
1 other identifier
interventional
140
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Sep 2021
Typical duration for not_applicable diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedNovember 4, 2020
November 1, 2020
2 years
October 27, 2020
November 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c
Change in glycated haemoglobin (HbA1c)
From baseline to 6 months
Secondary Outcomes (9)
HbA1c
From baseline to 3 months
Weight
At Months 3 and 6 from baseline
Body mass index
At Months 3 and 6 from baseline
Body fat mass (Bioelectrical impedance analysis)
At Months 3 and 6 from baseline
Body fat percentage (Bioelectrical impedance analysis)
At Months 3 and 6 from baseline
- +4 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALIMPACT intervention
Control group
NO INTERVENTIONUsual care
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients with type 2 diabetes
- Live in Hauts de Chambéry, Biollay or Renaudie district
- Be able to give written consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Tricco AC, Ivers NM, Grimshaw JM, Moher D, Turner L, Galipeau J, Halperin I, Vachon B, Ramsay T, Manns B, Tonelli M, Shojania K. Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta-analysis. Lancet. 2012 Jun 16;379(9833):2252-61. doi: 10.1016/S0140-6736(12)60480-2. Epub 2012 Jun 9.
PMID: 22683130BACKGROUNDAttridge M, Creamer J, Ramsden M, Cannings-John R, Hawthorne K. Culturally appropriate health education for people in ethnic minority groups with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2014 Sep 4;2014(9):CD006424. doi: 10.1002/14651858.CD006424.pub3.
PMID: 25188210BACKGROUNDCaptieux M, Pearce G, Parke HL, Epiphaniou E, Wild S, Taylor SJC, Pinnock H. Supported self-management for people with type 2 diabetes: a meta-review of quantitative systematic reviews. BMJ Open. 2018 Dec 14;8(12):e024262. doi: 10.1136/bmjopen-2018-024262.
PMID: 30552277BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2020
First Posted
November 4, 2020
Study Start
September 1, 2021
Primary Completion
September 1, 2023
Study Completion
March 1, 2024
Last Updated
November 4, 2020
Record last verified: 2020-11