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

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ClinicalTrials.gov Identifier: NCT04780425
Recruitment Status : Active, not recruiting
First Posted : March 3, 2021
Last Update Posted : March 11, 2021
Sponsor:
Collaborators:
University of Leicester
Utrecht University
Information provided by (Responsible Party):
Korle-Bu Teaching Hospital, Accra, Ghana

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: DESMOND Other: usual care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: Persons delivering the intervention are not involved in patient care
Primary Purpose: Supportive Care
Official 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
Actual Study Start Date : January 26, 2021
Estimated Primary Completion Date : May 22, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in mean glaciated heamoglobin (HbA1c) at three months [ Time Frame: 3 months ]
    change in glycaemic control

  2. 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

  3. Change in mean WHO quality of life (WHOQoL BREF) score at three months [ Time Frame: 3 months ]
    change in quality of life


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780425


Locations
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Ghana
Korle Bu Teaching Hospital
Accra, Ghana
Weija Gbawe Municipal Hospital
Accra, Ghana
Sponsors and Collaborators
Korle-Bu Teaching Hospital, Accra, Ghana
University of Leicester
Utrecht University
Investigators
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Principal Investigator: Roberta Lamptey, FWACP; MSc Korle Bu Teaching Hospital
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Responsible Party: Korle-Bu Teaching Hospital, Accra, Ghana
ClinicalTrials.gov Identifier: NCT04780425    
Other Study ID Numbers: KBTH-IRB 100017512020
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Korle-Bu Teaching Hospital, Accra, Ghana:
structured diabetes self-management education
DESMOND
SSA
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases