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

NCT ID: NCT04780425

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-26
• Study Completion Date: 2021-06-12

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

DESMOND

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

Group Type: EXPERIMENTAL

DESMOND

Intervention Type: BEHAVIORAL

as previously described

USUAL CARE

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

Group Type: ACTIVE_COMPARATOR

usual care

Intervention Type: OTHER

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

Interventions

DESMOND

as previously described

Intervention Type: BEHAVIORAL

usual care

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leicester

OTHER

Sponsor Role: collaborator

Utrecht University

OTHER

Sponsor Role: collaborator

Korle-Bu Teaching Hospital, Accra, Ghana

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberta Lamptey, FWACP; MSc

Role: PRINCIPAL_INVESTIGATOR

Korle Bu Teaching Hospital

Locations

Korle Bu Teaching Hospital

Accra, , Ghana

Weija Gbawe Municipal Hospital

Accra, , Ghana

Countries

Ghana

References

Lamptey R, Amoakoh-Coleman M, Barker MM, Iddi S, Hadjiconstantinou M, Davies M, Darko D, Agyepong I, Acheampong F, Commey M, Yawson A, Grobbee DE, Adjei GO, Klipstein-Grobusch K. Change in glycaemic control with structured diabetes self-management education in urban low-resource settings: multicentre randomised trial of effectiveness. BMC Health Serv Res. 2023 Feb 24;23(1):199. doi: 10.1186/s12913-023-09188-y.

Reference Type: DERIVED

PMID: 36829179 (View on PubMed)

Other Identifiers

KBTH-IRB 100017512020

Identifier Type: -

Identifier Source: org_study_id