Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatment structured self-management group education during 2 years
Sponsor Centre Hospitalier Universitaire de la Réunion
Collaborator Ministry of Health, France
Start date October 2011
End date November 2016
Trial size 240 participants
Trial identifier NCT01425866, 2010/CHR/03

Summary

Type 2 diabetes has a growing impact on populations and public health worldwide. Clinical trials have clearly demonstrated that a better control of blood glucose level and of other risk factors is efficient in preventing or retarding the complications of the disease. On Reunion island, Type 2 diabetes is present in 18% of population aged 30 or older with a high level of socio-economic deprivation. The hypothesis of the ERMIES study is that a structured group self-management education maintained at the community level for 2 years in patients with insufficiently controlled type 2 diabetes has better metabolic results (as attested by improvement in HbA1c level) at 2 yrs, compared to an initial short term (< 3 months) self-management program, based on the same theoretical basis and framework (learning nests empowerment). A total of 240 adults living in Reunion Island, with type 2 diabetes mellitus with HbA1c ≥ 7.5% on a stable treatment for at least 3 months will be randomly allocated to 2 intervention arms: either a short term (< 3 months) program (1 to 7 thematic 2-hr long sessions depending on individual assessment), or a long term program including the same initial program as 1st arm, but with group self management education sessions, maintained for 2 years (4-monthly assessment, empowerment, and contextual action planning; facultative additional specific thematic sessions being delivered if needed). Medical visits will be held quarterly for the recording of outcome measures (HbA1c, blood pressure, anthropometrics, tobacco consumption, diabetes complications) and yearly for blood glucose, lipids, micro-albuminuria or proteinuria, creatinine clearance, diet and exercise (questionnaires), treatment recording, quality of life, self-efficacy, anxiety and depression scales, and social support.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Long-term program including initial self-management education program (1 to 7 sessions, based on individual assessment), and follow-up group sessions maintained for 2 years (4-monthly assessment, empowerment, and contextual action planning; facultative additional specific thematic sessions being delivered if needed).
structured self-management group education during 2 years
After an initial intensive group education, four-monthly follow-up self-management group education sessions for 2 years. Each session is based on empowerment, socio-constructivism, social learning theory: personalized assessment (BG and risk factors, actions: realized, planned, achieved (or not), cognitive work, analysis of individual and social context and environment (facilitators, obstacles) then action planning. Specific additional sessions can be scheduled (food management, diabetes treatment and hypoglycemia, exercise, self monitoring of BG, insulin dosage, foot care). Sessions are framed, and structured, with patient booklet support. Sessions are delivered at the community level, by trained registered nurses, under the coordination of the health management network Reucare.
(Active Comparator)
Initial self-management group education: 1 to 7 sessions (< 3 months), based on individual assessment.
structured self-management group education during 2 years
After an initial intensive group education, four-monthly follow-up self-management group education sessions for 2 years. Each session is based on empowerment, socio-constructivism, social learning theory: personalized assessment (BG and risk factors, actions: realized, planned, achieved (or not), cognitive work, analysis of individual and social context and environment (facilitators, obstacles) then action planning. Specific additional sessions can be scheduled (food management, diabetes treatment and hypoglycemia, exercise, self monitoring of BG, insulin dosage, foot care). Sessions are framed, and structured, with patient booklet support. Sessions are delivered at the community level, by trained registered nurses, under the coordination of the health management network Reucare.

Primary Outcomes

Measure
Mean change in glycated haemoglobin (GlyHb)
time frame: 0 and 2 years

Secondary Outcomes

Measure
Mean change in glycated haemoglobin (GlyHb)
time frame: 0 and 1 year
change in GlyHb
time frame: quarterly up to 2 yrs
Blood sugar and lipids
time frame: 1 and 2 yrs
diabetes complications
time frame: 1 and 2 yrs
health behaviours
time frame: 1 and 2 yrs
anti-diabetic therapy
time frame: 1 and 2 yrs
health care process
time frame: 1 and 2 yrs
Psychometric scales
time frame: 1 and 2 yrs
Quality of Life
time frame: 1 and 2 yrs
Change in tobacco consumption
time frame: quarterly up to 2 yrs
Change in fasting blood glucose
time frame: quarterly up to 2 yrs
Change in body mass index
time frame: quarterly up to 2 yrs
Change in waist circumference
time frame: quarterly up to 2 yrs
Change in blood pressure
time frame: quarterly up to 2 yrs

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Type 2 diabetes - HbA1c ≥ 7,5% more than 3 months - Adults - ≥ 1 year ADO and/or insulin and/or GLP-1 analog - antidiabetic treatment unchanged since 3 months (no change of treatment in the last 3 months, except for insulin dosage) - Living in Reunion Island - Affiliated to French national health insurance - Signed informed consent Exclusion Criteria: - Treatment or associated conditions that would influence glycemic control, such as corticotherapy, cancer, inflammatory chronic diseases - Hospitalisation linked to diabetes < 3 months - Structured patient education in the past 3 months - Severe diabetes complications (e.g. ischemic or proliferative retinopathy, severe renal failure (clearance < 15 ml/min), acute ischemic heart disease (< 6 months, foot lesion) - Pregnancy (on-going or planned during the study) - Evolutive cancer - Physical or cognitive heavy handicap - Concomitant participation to a therapeutic trial

Additional Information

Official title Multicenter Randomized Trial of Structured Educational Intervention at the Community Level in Insufficiently Controlled Patients With Type 2 Diabetes in Reunion Island
Principal investigator Xavier Debussche, MD
Description Randomised clinical trial comparing 2 parallel arms of educational intervention with the hypothesis of the superiority of a 2-year maintenance of a structured, theoretically-based, educational follow-up. All subjects of both arms will beneficiate from an initial structured educational program (< 3-months). Subjects, educators, and investigators will be unaware of the group allocation during this initial round. Then the intervention arm will undergo a 2 years self management educational follow-up program. Randomisation will be stratified on 2 factors : centres (5 strata) and anti diabetic treatment (2 strata: insulin-treated or not). All group sessions (3-10 subjects, 2 hr-long, one assessment group session and 6 facultative additional specific sessions for each round [initial in both arms or follow-up in the intervention arm], as needed and planned during the first) will be held at the community level, as closer as possible to the subjects' residence. Educators are specifically trained and the educational sessions are structured and coordinated in the framing and organisational supervision of the health management network "ReuCARE" in Reunion island. Subjects of both arms will continue quarterly to attend at the outpatient clinic of the centre. This trial is associated to a qualitative ethno-sociological study on a sample of 30-40 subjects, with in-depth interviews and ethnographic observation of group sessions, with the specific aim of describing the learning processes, coping, health and functional literacy, social and contextual issues.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de la Réunion.