Structured Diabetes Self-Management Education and Care Outcomes in Adults liVIng With Type 2 Diabetes in Accra, Ghana

Study Overview
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Brief Summary
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We aim to study the effect of a structured diabetes education program (DESMOND) on diabetes outcomes in a ghanaian population over 3 months

Detailed Description
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Protocol summary Background: Health systems in low-income countries are overburdened. Corona virus disease-19 (COVID-19) is a pandemic caused by a novel corona virus, Severe acute respiratory syndrome-corona virus 2 (SARS-CoV2) while diabetes is a long-standing global epidemic. COVID-19 further stresses the already overburdened health systems and Public Health measures to contain COVID-19 have severely disrupted health service delivery, particularly routine care. Delivery of diabetes specific education has traditionally been tied to routine visits and delivered in-person. COVID-19 will likely continue to influence service delivery beyond the pandemic, thus alternative ways of delivering diabetes specific education is needed. Diabetes self-management education is vital to providing diabetes care. It equips patients with critical knowledge and skills for self-care. Recent edicts to stay home in relation to COVID-19 have further heightened the importance of self-care. Appropriate self-management behaviours are associated with lower levels of diabetes related distress, better quality of life and diabetes outcomes overall. Maintaining tight glycaemic control, early in diabetes is associated with fewer microvascular complications and vice versa. Complications of diabetes are prevalent in low resource settings in Africa; partly because of inadequate knowledge on self-care. Diabetes self-management education which is structured and tailor-made for low resource settings may modify self-care behaviors and result in improved self-care, glycaemic control and quality of life. Aim: To compare structured diabetes self-management education with standard of care among adults living with type 2 diabetes Methods: A prospective parallel-group randomised controlled trial with three months follow-up will be conducted in KBTH Polyclinic/Family Medicine Centre and Weija Gbawe Municipal Hospital, two primary care facilities in Accra. Participants will be individually randomised to standard of care or 6 hours of structured diabetes self-management education (DSME) delivered in person on one day . Each arm will have hundred participants. The standard of care arm will receive unstructured DSME as per existing protocols at each study site. The study population will be adults living with diabetes. The primary outcome, mean glycated haemoglobin (HbA1c ) will be measured at three months. Expected outcomes: It is expected that there will be no difference in change in mean glycaemic control, self-efficacy or quality of life at three months between the two arms.

Official Title
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A Randomised Parallel-group Multi-centre Study to Evaluate the Effect of Structured Diabetes Self-management Education Versus Standard of Care on Glycaemic Control, Self-efficacy and Quality of Life in Adults in Two Low Resource Settings in Accra Subsequent to COVID-19

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: DESMOND
* Other: usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Inclusion criteria Self-identified as Ghanaian Ability to speak either English and or Twi be aged > 18 years be receiving treatment at the study site as an out-patient be willing to accept the 6-hour DSME intervention be physically able to participate be primarily responsible for their own care be ambulant at time of recruitment be able to participate in activities in a group setting have permanent residence in Greater Accra Exclusion Criteria: known to have cognitive defects known to have type I diabetes known to be pregnant at the time of recruitment or planning to become pregnant during the study or have given birth less than three months prior to recruitment known to have sickle cell disease Participating in another intervention study at time of recruitment known to have chronic medical complications of diabetes (cardiac, renal, neuropathy, hepatic) or systemic illness at the time of recruitment recruitment of a member of the patients household for this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DESMOND<br>receive usual care plus a structured diabetes self-management education program delivered once over 6hours | Behavioral: DESMOND<br>* as previously described<br>|
| Active Comparator: USUAL CARE<br>Receive usual care as per standard treatment guidelines of ghana unstructured education during clinic visits for routine care | Other: usual care<br>* usual care as per standard treatment guidelines of Ghana unstructured/adhoc diabetes education during clinic visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean glaciated heamoglobin (HbA1c) at three months | change in glycaemic control | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean fasting plasma glucose (FPG) at three months | change in fasting plasma glucose | 3 months | 
| Change in mean fasting blood glucose (FBG) at three months | change in fasting blood glucose | 3 months | 
| Change in mean blood pressure (BP) at three months | change in blood pressure | 3 months | 
| Change in waist circumference (WC) at three months | change in waist circumference | 3 months | 
| Change in neck circumference (NC) at three months | change in neck circumference | 3 months | 
| Change in body weight (BW) at three months | change in body weight | 3 months | 
| Change in problem areas in diabetes (PAID-5) scores | Change in diabetes related distress at three months, scored from 0 to 4 for each question. minimum score is 0 maximum score is 20, higher scores mean better outcomes | 3 months | 
| Change in mean summary of diabetes self-care activities (SDSCA) score at three months | change in self-efficacy, min score 0 and max score 7 for each question, higher scores mean better outcomes | 3 months | 
| Change in mean WHO quality of life (WHOQoL BREF) score at three months | change in quality of life | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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structured diabetes self-management education, SSA, DESMOND