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

Type 2 Diabetes Clinical Trial

— ERMIES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425866
• Other study ID #: 2010/CHR/03
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: September 2016

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
France	Groupe Hopitalier Est Réunion	Saint Benoît	La Réunion
France	Department of endocrinology, University Hospital Reunion Island - Felix Guyon Site	Saint Denis De La Réunion
France	Centre Hospitalier Gabriel Martin	Saint Paul	La Réunion
France	Diabetolgy - UNiversity Hospital Sud Réunion	Saint Pierre	La Réunion

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

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