Clinical trial NCT01425866: Two Years Maintenance of Structured Group Self-management Education in Type 2 Diabetes : a Randomized Controlled Trial
Official title: Multicenter Randomized Trial of Structured Educational Intervention at the Community Level in Insufficiently Controlled Patients With Type 2 Diabetes in Reunion Island
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus
Diabetes Mellitus, Type 2
Structured self-management education
Therapeutic patient education
Lifestyle changes
Self-management Blood glucose
Empowerment
Adult learning
Socio-constructivism
Health management network
Reunion island
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2011-08-30
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change in glycated haemoglobin (GlyHb)
timeFrame: 0 and 2 years
Secondary outcomes:
measure: Mean change in glycated haemoglobin (GlyHb)
timeFrame: 0 and 1 year
measure: change in GlyHb
timeFrame: quarterly up to 2 yrs
measure: Blood sugar and lipids
timeFrame: 1 and 2 yrs
measure: diabetes complications
timeFrame: 1 and 2 yrs
measure: health behaviours
timeFrame: 1 and 2 yrs
measure: anti-diabetic therapy
timeFrame: 1 and 2 yrs
measure: health care process
timeFrame: 1 and 2 yrs
measure: Psychometric scales
timeFrame: 1 and 2 yrs
measure: Quality of Life
timeFrame: 1 and 2 yrs
measure: Change in tobacco consumption
timeFrame: quarterly up to 2 yrs
measure: Change in fasting blood glucose
timeFrame: quarterly up to 2 yrs
measure: Change in body mass index
timeFrame: quarterly up to 2 yrs
measure: Change in waist circumference
timeFrame: quarterly up to 2 yrs
measure: Change in blood pressure
timeFrame: quarterly up to 2 yrs
Other outcomes:
Locations:
city: Saint Benoît
country: France
facility: Groupe Hopitalier Est Réunion
state: La Réunion
city: Saint Paul
country: France
facility: Centre Hospitalier Gabriel Martin
state: La Réunion
city: Saint Pierre
country: France
facility: Diabetolgy - UNiversity Hospital Sud Réunion
state: La Réunion
city: Saint Denis De La Réunion
country: France
facility: Department of endocrinology, University Hospital Reunion Island - Felix Guyon Site
Study officials:
affiliation: Diabetology - University Hospital Reunion Island - Felix Guyon Site
name: Xavier Debussche, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine - University Hospital Reunion Island - Felix Guyon Site
name: Jean Luc YVIN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diabetology - University Hospital Reunion Island - GHSR
name: Stéphane SCHNEEBELI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Gabriel Martin
name: Jean Hugues GATINA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Groupe Hospitalier Est Réunion
name: Yogananda THIRAPATHIAPPADU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Debussche X, Balcou-Debussche M, Ballet D, Caroupin-Soupoutevin J. Health literacy in context: struggling to self-manage diabetes - a longitudinal qualitative study. BMJ Open. 2022 Jun 14;12(6):e046759. doi: 10.1136/bmjopen-2020-046759.
citation: Debussche X, Collin F, Fianu A, Balcou-Debussche M, Fouet-Rosiers I, Koleck M, Favier F. Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island. Cardiovasc Diabetol. 2012 Aug 2;11:91. doi: 10.1186/1475-2840-11-91.