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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: DESMOND; Other: usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Accra, Ghana
    • Korle Bu Teaching Hospital
  • Accra, Ghana
    • Weija Gbawe Municipal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Korle-Bu Teaching Hospital, Accra, Ghana
• Collaborators: University of Leicester; Utrecht University
• Investigators: Principal Investigator: Roberta Lamptey, FWACP; MSc, Korle Bu Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Actual): June 9, 2021
• Study Completion (Actual): June 12, 2021

Study Registration Dates

• First Submitted: February 28, 2021
• First Submitted That Met QC Criteria: February 28, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: SSA; structured diabetes self-management education; DESMOND
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: KBTH-IRB 100017512020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No