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Diabetes Mellitus, Type 2SMSCOVIDNCT04780425

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

A study testing DESMOND in people with Diabetes Mellitus, Type 2, run by Korle-Bu Teaching Hospital, Accra, Ghana at 2 sites in Ghana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
DESMOND
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
2 sitesGhana
Study dates
26 Jan 2021to 12 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Ghana2 sites

  • Korle Bu Teaching Hospital

    Accra

  • Weija Gbawe Municipal Hospital

    Accra

Other trials in Ghana

About this study

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

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

Read the 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.

Being tested
DESMOND, usual care
Keywords
structured diabetes self-management education, DESMOND, SSA
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DESMONDBehavioural

    as previously described

  • usual careOther

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

Study groups in NCT04780425
Study groupRoleWhat they receive
DESMONDExperimentalreceive usual care plus a structured diabetes self-management education program delivered once over 6hours
Receives: Behavioral: DESMOND
USUAL CAREActive comparatorReceive usual care as per standard treatment guidelines of ghana unstructured education during clinic visits for routine care
Receives: Other: usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    change in glycaemic control

    Measured: 3 months

Secondary outcomes (9)

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

    change in fasting plasma glucose

    Measured: 3 months

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

    change in fasting blood glucose

    Measured: 3 months

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

    change in blood pressure

    Measured: 3 months

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

    change in waist circumference

    Measured: 3 months

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

    change in neck circumference

    Measured: 3 months

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

    change in body weight

    Measured: 3 months

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

    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

    Measured: 3 months

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

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

    Measured: 3 months

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

    change in quality of life

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2021
  2. Study start26 Jan 2021
  3. Primary completion9 Jun 2021
  4. Study completion12 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04780425
Sponsor's protocol ID
KBTH-IRB 100017512020
Acronym
SMSCOVID
Status last verified
Aug 2022
First submitted
28 Feb 2021
Last updated
16 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36829179

Questions about this trial

What is this clinical trial studying?

A study testing DESMOND in people with Diabetes Mellitus, Type 2, run by Korle-Bu Teaching Hospital, Accra, Ghana at 2 sites in Ghana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mean glaciated heamoglobin (HbA1c) at three months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04780425, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.

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