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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centre Hospitalier Universitaire de la Réunion
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier:
NCT01425866
First received: August 26, 2011
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Behavioral: Structured self-management group education during 2 years

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Multicenter Randomized Trial of Structured Educational Intervention at the Community Level in Insufficiently Controlled Patients With Type 2 Diabetes in Reunion Island

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de la Réunion:

Primary Outcome Measures:
  • Mean change in glycated haemoglobin (GlyHb) [ Time Frame: 0 and 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in glycated haemoglobin (GlyHb) [ Time Frame: 0 and 1 year ] [ Designated as safety issue: No ]
  • change in GlyHb [ Time Frame: quarterly up to 2 yrs ] [ Designated as safety issue: No ]
  • Blood sugar and lipids [ Time Frame: 1 and 2 yrs ] [ Designated as safety issue: No ]
    Blood sugar Total, HDL and LDL cholesterol, triglycerides

  • diabetes complications [ Time Frame: 1 and 2 yrs ] [ Designated as safety issue: No ]
    retinopathy stages, micro-albuminuria or proteinuria, creatinine clearance, foot risk grade, ischemic heart or cerebral disease

  • health behaviours [ Time Frame: 1 and 2 yrs ] [ Designated as safety issue: No ]
    physical activity and diet (Baecke and food frequency questionnaires)

  • anti-diabetic therapy [ Time Frame: 1 and 2 yrs ] [ Designated as safety issue: No ]
    type, dosage

  • health care process [ Time Frame: 1 and 2 yrs ] [ Designated as safety issue: No ]
    medical follow-up and appointments, compliance (questionnaire)

  • Psychometric scales [ Time Frame: 1 and 2 yrs ] [ Designated as safety issue: No ]
    self-efficacy, social support, HAD (anxiety and depression)

  • Quality of Life [ Time Frame: 1 and 2 yrs ] [ Designated as safety issue: No ]
    short DQOL adapted and validated for Reunion

  • Change in tobacco consumption [ Time Frame: quarterly up to 2 yrs ] [ Designated as safety issue: No ]
  • Change in fasting blood glucose [ Time Frame: quarterly up to 2 yrs ] [ Designated as safety issue: No ]
  • Change in body mass index [ Time Frame: quarterly up to 2 yrs ] [ Designated as safety issue: No ]
  • Change in waist circumference [ Time Frame: quarterly up to 2 yrs ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: quarterly up to 2 yrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: October 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425866

Contacts
Contact: Xavier Debussche, MD 262 (0) 262 90 56 16 xavier.debussche@chu-reunion.fr
Contact: Vanessa Basque 262 (0) 262 35 95 25 vanessa.basque@chu-reunion.fr

Locations
France
Groupe Hopitalier Est Réunion Recruiting
Saint Benoît, La Réunion, France, 97470
Contact: Yogananda THIRAPATHI-APPADU, MD    02 62 50 84 56    yoga.t@wanadoo.fr   
Principal Investigator: Yogananda THIRAPATHI-APPADU, MD         
Centre Hospitalier Gabriel Martin Recruiting
Saint Paul, La Réunion, France, 97863
Contact: Jean Hugues GATINA, MD    02 62 45 87 41    gatina.jh@ch-gmartin.fr   
Principal Investigator: Jean Hugues Gatina, MD         
Diabetolgy - UNiversity Hospital Sud Réunion Recruiting
Saint Pierre, La Réunion, France, 97448
Contact: Stéphane SCHNEEBELI, MD       stephane.schneebeli@chu-reunion.fr   
Principal Investigator: Stephane Schneebeli, MD         
Department of endocrinology, University Hospital Reunion Island - Felix Guyon Site Recruiting
Saint Denis de La Réunion, France, 97405
Contact: Xavier Debussche, MD    262 (0) 262 90 56 16    xavier.debussche@chu-reunion.fr   
Principal Investigator: Xavier Debussche, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
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
  More Information

No publications provided by Centre Hospitalier Universitaire de la Réunion

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT01425866     History of Changes
Other Study ID Numbers: 2010/CHR/03
Study First Received: August 26, 2011
Last Updated: July 24, 2014
Health Authority: France: Ministry of Health

Keywords provided by Centre Hospitalier Universitaire de la Réunion:
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 27, 2014