NCT04780425

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 28, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2021

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

February 28, 2021

Last Update Submit

August 12, 2022

Conditions

Diabetes Mellitus, Type 2

Keywords

structured diabetes self-management educationDESMONDSSA

Outcome Measures

Primary Outcomes (1)

  • Change in mean glaciated heamoglobin (HbA1c) at three months

    change in glycaemic control

    3 months

Secondary Outcomes (9)

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

    3 months

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

    3 months

  • Change in mean blood pressure (BP) at three months

    3 months

  • Change in waist circumference (WC) at three months

    3 months

  • Change in neck circumference (NC) at three months

    3 months

  • +4 more secondary outcomes

Study Arms (2)

DESMOND

EXPERIMENTAL

receive usual care plus a structured diabetes self-management education program delivered once over 6hours

Behavioral: DESMOND

USUAL CARE

ACTIVE COMPARATOR

Receive usual care as per standard treatment guidelines of ghana unstructured education during clinic visits for routine care

Other: usual care

Interventions

DESMONDBEHAVIORAL

as previously described

DESMOND
usual careOTHER

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

USUAL CARE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Korle Bu Teaching Hospital

Accra, Ghana

Location

Weija Gbawe Municipal Hospital

Accra, Ghana

Location

Related Publications (1)

  • 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.

    PMID: 36829179DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Roberta Lamptey, FWACP; MSc

    Korle Bu Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Persons delivering the intervention are not involved in patient care
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2021

First Posted

March 3, 2021

Study Start

January 26, 2021

Primary Completion

June 9, 2021

Study Completion

June 12, 2021

Last Updated

August 16, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

GH(2)