Clinical trial NCT04616053: IMPACT Intervention
Official title: A Randomised Controlled Trial to Evaluate the Effectiveness of a Multidisciplinary Team Intervention on Glycaemic Control for Disadvantaged Type 2 Diabetes Patients in France.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: primary health care
patient-centered care
poverty areas
vulnerable populations
Glycated Hemoglobin A
Lead sponsor: Pole de Sante Chambery Nord
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: HbA1c
timeFrame: From baseline to 3 months
measure: Weight
timeFrame: At Months 3 and 6 from baseline
measure: Body mass index
timeFrame: At Months 3 and 6 from baseline
measure: Body fat mass (Bioelectrical impedance analysis)
timeFrame: At Months 3 and 6 from baseline
measure: Body fat percentage (Bioelectrical impedance analysis)
timeFrame: At Months 3 and 6 from baseline
measure: Muscle mass (Bioelectrical impedance analysis)
timeFrame: At Months 3 and 6 from baseline
measure: Lipids - HDL cholesterol
timeFrame: From baseline to 6 months
measure: Lipids - LDL cholesterol
timeFrame: From baseline to 6 months
measure: Lipids - triglycerides
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Attridge 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.
citation: Captieux 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.