Clinical trial NCT04780425: Structured Diabetes Self-Management Education and Care Outcomes in Adults liVIng With Type 2 Diabetes in Accra, Ghana
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: structured diabetes self-management education
DESMOND
SSA
Lead sponsor: Korle-Bu Teaching Hospital, Accra, Ghana
Sponsor class: OTHER
Collaborators: name: University of Leicester
name: Utrecht University
First posted: 2021-03-03
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in mean glaciated heamoglobin (HbA1c) at three months
timeFrame: 3 months
Secondary outcomes:
measure: Change in mean fasting plasma glucose (FPG) at three months
timeFrame: 3 months
measure: Change in mean fasting blood glucose (FBG) at three months
timeFrame: 3 months
measure: Change in mean blood pressure (BP) at three months
timeFrame: 3 months
measure: Change in waist circumference (WC) at three months
timeFrame: 3 months
measure: Change in neck circumference (NC) at three months
timeFrame: 3 months
measure: Change in body weight (BW) at three months
timeFrame: 3 months
measure: Change in problem areas in diabetes (PAID-5) scores
timeFrame: 3 months
measure: Change in mean summary of diabetes self-care activities (SDSCA) score at three months
timeFrame: 3 months
measure: Change in mean WHO quality of life (WHOQoL BREF) score at three months
timeFrame: 3 months
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: Korle Bu Teaching Hospital
city: Accra
country: Ghana
facility: Weija Gbawe Municipal Hospital
Study officials:
affiliation: Korle Bu Teaching Hospital
name: Roberta Lamptey, FWACP; MSc
role: PRINCIPAL_INVESTIGATOR
References: