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

NCT ID: NCT01425866

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2016-09-30

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Structured self-management group education during 2 years

Intervention Type: BEHAVIORAL

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.

Initial self-management education

Initial self-management group education: 1 to 7 sessions (\< 3 months), based on individual assessment.

Group Type: ACTIVE_COMPARATOR

Structured self-management group education during 2 years

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier Debussche, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetology - University Hospital Reunion Island - Felix Guyon Site

Jean Luc YVIN, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine - University Hospital Reunion Island - Felix Guyon Site

Stéphane SCHNEEBELI, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetology - University Hospital Reunion Island - GHSR

Jean Hugues GATINA, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Gabriel Martin

Yogananda THIRAPATHIAPPADU, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier Est Réunion

Locations

Groupe Hopitalier Est Réunion

Saint-Benoît, La Réunion, France

Centre Hospitalier Gabriel Martin

Saint-Paul, La Réunion, France

Diabetolgy - UNiversity Hospital Sud Réunion

Saint-Pierre, La Réunion, France

Department of endocrinology, University Hospital Reunion Island - Felix Guyon Site

Saint Denis de La Réunion, , France

Countries

France

References

Flaus-Furmaniuk A, Fianu A, Lenclume V, Chirpaz E, Balcou-Debussche M, Debussche X, Marimoutou C. Attrition and social vulnerability during 2-year-long structured care in type 2 diabetes, the ERMIES randomized controlled trial. BMC Endocr Disord. 2022 Dec 13;22(1):314. doi: 10.1186/s12902-022-01211-3.

Reference Type: DERIVED

PMID: 36510180 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35701054 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22856504 (View on PubMed)

Other Identifiers

2010/CHR/03

Identifier Type: -

Identifier Source: org_study_id