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Open Access Highly Accessed Study protocol

Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial

Bob Mash1*, Naomi Levitt2, Krisela Steyn3, Merrick Zwarenstein4 and Stephen Rollnick5

Author affiliations

1 Family Medicine and Primary Care, Stellenbosch University, Box 19063, Tygerberg, 7505, South Africa

2 Diabetic Medicine and Endocrinology, University of Cape Town and Chronic Diseases Initiative in Africa, Faculty of Health Sciences, University of Cape Town, P.Bag X3, Observatory 7935, Room J47 – 85, Old Groote Schuur Hospital Building, Cape Town, South Africa

3 Chronic Diseases Initiative in Africa, Faculty of Health Sciences, University of Cape Town, P.Bag X3, Observatory, Room J47 – 85, Old Groote Schuur Hospital Building, Cape Town, 7935, South Africa

4 Institute for Clinical Evaluative Sciences and Department of Health Policy, Management and Evaluation, University of Toronto, G1 06, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada

5 Professor of Health Care Communication, Department of Primary Care and Public Health, Cardiff University, Neuadd Meirionnydd Heath Park, Cardiff, WALES, CF14 4YS, UK

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Citation and License

BMC Family Practice 2012, 13:126  doi:10.1186/1471-2296-13-126

Published: 24 December 2012

Abstract

Background

Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life.

Methods

Trial design: Pragmatic cluster randomized controlled trial

Participants: Type 2 diabetic patients attending 45 public sector community health centres in Cape Town

Interventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room.

Objective: To evaluate the effectiveness of the group diabetes education programme

Outcomes: Primary outcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. Secondary outcomes: self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of life

Randomisation: Computer generated random numbers

Blinding: Patients, health promoters and research assistants could not be blinded to the health centre’s allocation

Numbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570.

Discussion

The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely.

Trial register

Pan African Clinical Trial Registry PACTR201205000380384

Keywords:
Diabetes; Group education; Health education; Motivational interviewing; Mid-level health workers; South Africa; Primary care