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Completed

NCT Number: NCT04780425

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korle Bu Teaching Hospital, Accra, Ghana

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

DESMOND

Behavioral

as previously described

Usual Care

Other

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

Primary outcomes

  1. Change in mean glaciated heamoglobin (HbA1c) at three months

    Time frame: 3 months

    change in glycaemic control

Secondary outcomes

  1. Change in mean fasting plasma glucose (FPG) at three months

    Time frame: 3 months

    change in fasting plasma glucose

  2. Change in mean fasting blood glucose (FBG) at three months

    Time frame: 3 months

    change in fasting blood glucose

  3. Change in mean blood pressure (BP) at three months

    Time frame: 3 months

    change in blood pressure

  4. Change in waist circumference (WC) at three months

    Time frame: 3 months

    change in waist circumference

  5. Change in neck circumference (NC) at three months

    Time frame: 3 months

    change in neck circumference

  6. Change in body weight (BW) at three months

    Time frame: 3 months

    change in body weight

  7. Change in problem areas in diabetes (PAID-5) scores

    Time frame: 3 months

    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

  8. Change in mean summary of diabetes self-care activities (SDSCA) score at three months

    Time frame: 3 months

    change in self-efficacy, min score 0 and max score 7 for each question, higher scores mean better outcomes

  9. Change in mean WHO quality of life (WHOQoL BREF) score at three months

    Time frame: 3 months

    change in quality of life

Sponsors and collaborators

Lead sponsor

Korle-Bu Teaching Hospital, Accra, Ghana

Other

Collaborators

  • University of Leicester
  • Utrecht University

Registry information

Official study 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

Acronym: SMSCOVID

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2021
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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