Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202103574924457 Date of Approval: 26/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Structured Diabetes Self-Management Education and Care Outcomes in Adults liVIng With Type 2 Diabetes in Accra, Ghana (SMSCOVID) COVID-19
Official scientific 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
Brief summary describing the background and objectives of the trial Protocol summary: 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(DSME) 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 (QoL). Aim: To compare structured DSME with standard of care among adults living with type 2 diabetes Specific objectives 1.To determine the effect of structured DSME on glycaemic control,self-efficacy, and QoL, at three months in adults living with diabetes. 2.To describe the association between structured DSME, HbA1C,QoL and self-efficacy in adults living with diabetes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SMSCOVID
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 26/01/2021
Actual trial start date 26/01/2021
Anticipated date of last follow up 22/05/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 206
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Usual care unstructured group diabetes specific education provided for about 30 minutes prior to start of routine monthly clinic visits at weija study site and individualised education provided as part of routine monthly consultation which lasts about 15minutes in total from entry to exit of the consulting room. monthly unstructured group diabetes specific education provided for about 30 minutes prior to start of routine monthly clinic visits at weija study site and individualised education provided as part of routine monthly consultation which lasts about 15minutes in total from entry to exit of the consulting room. 103 Active-Treatment of Control Group
Experimental Group DESMOND EXTEND six hours of structured Diabetes self management education delivered once on a single day 6hours six hours of structured Diabetes self management education delivered once on a single day 103
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 999 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/11/2020 Korle Bu Teaching Hospital IRB
Ethics Committee Address
Street address City Postal code Country
Guggisberg ave Accra Kb77 Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/01/2021 Ghana Health Service ethics review committee
Ethics Committee Address
Street address City Postal code Country
Adabraka polyclinic digital address GA-050-3303 accra MB 190 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Change in mean glycated heamoglobin HbA1c (glycaemic control) at three months 2. Change in mean summary of diabetes self-care activities score SDSCA (self-efficacy) at three months 3. Change in mean WHO quality of life brief version WHOQoL BREF score at three months three months
Secondary Outcome 1. Change in mean fasting plasma glucose FPG at three months 2. Change in mean fasting blood glucose FBG at three months 3. Change in mean blood pressure BP at three months 4. Change in mean waist circumference WC at three months 5. Change in mean neck circumference NC (neck circumference)at three months 6. Change in mean body weight BW at three months 7. Change in problem areas in diadetes PAID-5 scores (diabetes related distress) at three months three months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Korle Bu Teaching Hospital Family Medicine Department Guggisberg avenue Accra Kb77 Ghana
Weija Gbawe Municipal Hospital McCarthy Hill Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Roberta Lamptey Guggisberg Avenue Accra Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Roberta Lamptey Guggisberg Avenue Accra Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
University of Leicester Fielding Johnson Building, University Road, Leicester LE1 7RH Leicester United Kingdom
Utrecht University Heidelberglaan 8, 3584 CS Utrecht, Netherlands Utrecht Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Roberta Lamptey roberta.lamptey@yahoo.com +233206301050 Guggisberg avenue
City Postal code Country Position/Affiliation
Accra Ghana Consultant Family Physician and Diabetologist Korle Bu Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Franklin Acheampong f.acheampong@kbth.gov.gh +233032666766 Guggisberg avenue
City Postal code Country Position/Affiliation
Accra Ghana Head of research Korle Bu Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Kerstin KlipsteinGrobusch k.klipstein-grobusch@umcutrecht.nl +3188756963 University medical center UMC utrecht
City Postal code Country Position/Affiliation
Utrecht Netherlands Julius center for health science UMC medical center Utrecht
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes de-identified IPD that underlies the results will be shared after publication of primary results and made available indefinitely to investigators whose proposed research have received ethical approval following execution of a data use agreement Informed Consent Form,Statistical Analysis Plan,Study Protocol after publication of primary results and made available indefinitely ethical approval execution of a data use agreement
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information