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

Conditions

• Type 2 Diabetes

Interventions

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.

Sponsors & Collaborators

• Ministry of Health, France

  collaborator OTHER_GOV

• Centre Hospitalier Universitaire de la Réunion

  lead OTHER

Principal Investigators

• Xavier Debussche, MD · Diabetology - University Hospital Reunion Island - Felix Guyon Site

• Jean Luc YVIN, MD · Department of Internal Medicine - University Hospital Reunion Island - Felix Guyon Site

• Stéphane SCHNEEBELI, MD · Diabetology - University Hospital Reunion Island - GHSR

• Jean Hugues GATINA, MD · Centre Hospitalier Gabriel Martin

• Yogananda THIRAPATHIAPPADU, MD · Groupe Hospitalier Est Réunion

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• France

Study Locations