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

Diabetes Mellitus, Type 2 Clinical Trial

— SMSCOVID  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780425
• Other study ID #: KBTH-IRB 100017512020
• Status: Completed
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: June 12, 2021

Study information

• Verified date: August 2022
• Source: Korle-Bu Teaching Hospital, Accra, Ghana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: June 12, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• DESMOND
as previously described

Other:
• usual care
usual care as per standard treatment guidelines of Ghana unstructured/adhoc diabetes education during clinic visits

Locations

Country	Name	City	State
Ghana	Korle Bu Teaching Hospital	Accra
Ghana	Weija Gbawe Municipal Hospital	Accra

Sponsors (3)

Lead Sponsor	Collaborator
Korle-Bu Teaching Hospital, Accra, Ghana	University of Leicester, Utrecht University

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean glaciated heamoglobin (HbA1c) at three months	change in glycaemic control	3 months
Secondary	Change in mean fasting plasma glucose (FPG) at three months	change in fasting plasma glucose	3 months
Secondary	Change in mean fasting blood glucose (FBG) at three months	change in fasting blood glucose	3 months
Secondary	Change in mean blood pressure (BP) at three months	change in blood pressure	3 months
Secondary	Change in waist circumference (WC) at three months	change in waist circumference	3 months
Secondary	Change in neck circumference (NC) at three months	change in neck circumference	3 months
Secondary	Change in body weight (BW) at three months	change in body weight	3 months
Secondary	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
Secondary	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
Secondary	Change in mean WHO quality of life (WHOQoL BREF) score at three months	change in quality of life	3 months