Two Years Maintenance of Structured Group Self-management Education in Type 2 Diabetes : a Randomized Controlled Trial (ERMIES)

Multicenter Randomized Trial of Structured Educational Intervention at the Community Level in Insufficiently Controlled Patients With Type 2 Diabetes in Reunion Island

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Structured self-management group education during 2 years

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Denis De La Réunion, France, 97405
    • Department of endocrinology, University Hospital Reunion Island - Felix Guyon Site
  • La Réunion
    • Saint Benoît, La Réunion, France, 97470
      • Groupe Hopitalier Est Réunion
    • Saint Paul, La Réunion, France, 97863
      • Centre Hospitalier Gabriel Martin
    • Saint Pierre, La Réunion, France, 97448
      • Diabetolgy - UNiversity Hospital Sud Réunion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2 years self management education; 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).	Behavioral: 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 education; Initial self-management group education: 1 to 7 sessions (< 3 months), based on individual assessment.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change in glycated haemoglobin (GlyHb)	0 and 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in glycated haemoglobin (GlyHb)		0 and 1 year
change in GlyHb		quarterly up to 2 yrs
Blood sugar and lipids	Blood sugar Total, HDL and LDL cholesterol, triglycerides	1 and 2 yrs
diabetes complications	retinopathy stages, micro-albuminuria or proteinuria, creatinine clearance, foot risk grade, ischemic heart or cerebral disease	1 and 2 yrs
health behaviours	physical activity and diet (Baecke and food frequency questionnaires)	1 and 2 yrs
anti-diabetic therapy	type, dosage	1 and 2 yrs
health care process	medical follow-up and appointments, compliance (questionnaire)	1 and 2 yrs
Psychometric scales	self-efficacy, social support, HAD (anxiety and depression)	1 and 2 yrs
Quality of Life	short DQOL adapted and validated for Reunion	1 and 2 yrs
Change in tobacco consumption		quarterly up to 2 yrs
Change in fasting blood glucose		quarterly up to 2 yrs
Change in body mass index		quarterly up to 2 yrs
Change in waist circumference		quarterly up to 2 yrs
Change in blood pressure		quarterly up to 2 yrs

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Xavier Debussche, MD, Diabetology - University Hospital Reunion Island - Felix Guyon Site; Principal Investigator: Jean Luc YVIN, MD, Department of Internal Medicine - University Hospital Reunion Island - Felix Guyon Site; Principal Investigator: Stéphane SCHNEEBELI, MD, Diabetology - University Hospital Reunion Island - GHSR; Principal Investigator: Jean Hugues GATINA, MD, Centre Hospitalier Gabriel Martin; Principal Investigator: Yogananda THIRAPATHIAPPADU, MD, Groupe Hospitalier Est Réunion

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2011
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: August 26, 2011
• First Submitted That Met QC Criteria: August 29, 2011
• First Posted (Estimated): August 30, 2011

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Diabetes Mellitus, Type 2; Lifestyle changes; Empowerment; Therapeutic patient education; Reunion island; Structured self-management education; Self-management Blood glucose; Adult learning; Socio-constructivism; Health management network
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2010/CHR/03