DESMOND
Behavioralas previously described
NCT Number: NCT04780425
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Korle Bu Teaching Hospital, Accra, Ghana
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
as previously described
usual care as per standard treatment guidelines of Ghana unstructured/adhoc diabetes education during clinic visits
Time frame: 3 months
change in glycaemic control
Time frame: 3 months
change in fasting plasma glucose
Time frame: 3 months
change in fasting blood glucose
Time frame: 3 months
change in blood pressure
Time frame: 3 months
change in waist circumference
Time frame: 3 months
change in neck circumference
Time frame: 3 months
change in body weight
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
Time frame: 3 months
change in self-efficacy, min score 0 and max score 7 for each question, higher scores mean better outcomes
Time frame: 3 months
change in quality of life
Korle-Bu Teaching Hospital, Accra, Ghana
Other
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
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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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