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

Korle-Bu Teaching Hospital, Accra, Ghana

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: DESMOND; Other: usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04780425

KBTH-IRB 100017512020

Details and patient eligibility

About

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

Full description

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.

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion criteria

1. Self-identified as Ghanaian
2. Ability to speak either English and or Twi
3. be aged > 18 years
4. be receiving treatment at the study site as an out-patient
5. be willing to accept the 6-hour DSME intervention
6. be physically able to participate
7. be primarily responsible for their own care
8. be ambulant at time of recruitment
9. be able to participate in activities in a group setting
10. have permanent residence in Greater Accra

Exclusion criteria

1. known to have cognitive defects
2. known to have type I diabetes
3. 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
4. known to have sickle cell disease
5. Participating in another intervention study at time of recruitment
6. known to have chronic medical complications of diabetes (cardiac, renal, neuropathy, hepatic) or systemic illness at the time of recruitment
7. recruitment of a member of the patients household for this study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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206 participants in 2 patient groups

DESMOND

Experimental group

Description:

receive usual care plus a structured diabetes self-management education program delivered once over 6hours

Treatment:

Behavioral: DESMOND

USUAL CARE

Active Comparator group

Description:

Receive usual care as per standard treatment guidelines of ghana unstructured education during clinic visits for routine care

Treatment:

Other: usual care