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NCT Number: NCT01425866

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hopitalier Est Réunion, Saint-Benoît, La Réunion, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured self-management group education during 2 years

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.

Primary outcomes

  1. Mean change in glycated haemoglobin (GlyHb)

    Time frame: 0 and 2 years

Secondary outcomes

  1. Mean change in glycated haemoglobin (GlyHb)

    Time frame: 0 and 1 year

  2. change in GlyHb

    Time frame: quarterly up to 2 yrs

  3. Blood sugar and lipids

    Time frame: 1 and 2 yrs

    Blood sugar Total, HDL and LDL cholesterol, triglycerides

  4. diabetes complications

    Time frame: 1 and 2 yrs

    retinopathy stages, micro-albuminuria or proteinuria, creatinine clearance, foot risk grade, ischemic heart or cerebral disease

  5. health behaviours

    Time frame: 1 and 2 yrs

    physical activity and diet (Baecke and food frequency questionnaires)

  6. anti-diabetic therapy

    Time frame: 1 and 2 yrs

    type, dosage

  7. health care process

    Time frame: 1 and 2 yrs

    medical follow-up and appointments, compliance (questionnaire)

  8. Psychometric scales

    Time frame: 1 and 2 yrs

    self-efficacy, social support, HAD (anxiety and depression)

  9. Quality of Life

    Time frame: 1 and 2 yrs

    short DQOL adapted and validated for Reunion

  10. Change in tobacco consumption

    Time frame: quarterly up to 2 yrs

  11. Change in fasting blood glucose

    Time frame: quarterly up to 2 yrs

  12. Change in body mass index

    Time frame: quarterly up to 2 yrs

  13. Change in waist circumference

    Time frame: quarterly up to 2 yrs

  14. Change in blood pressure

    Time frame: quarterly up to 2 yrs

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: ERMIES

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 30, 2011
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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