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Effectiveness of Diabetes Self-management Education on Glycaemic Control in Patients With T2DM

NCT07149311 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-08-29

No results posted yet for this study

Summary

This is a randomized controlled trial assessing the effectiveness of a nurse led diabetes self management education(DSME) given over a 6 month period via mixed delivery strategy (in-person and via phone calls) on Hemoglobin A1c(HbA1c), fasting blood glucose(FBG), blood pressure, body weight and low density lipoprotein cholesterol(LDL-C).

The main question this research seeks to answer is

1\. Does diabetes self-management education when combined with usual care improve glycaemic control when compared to usual care alone? Patients will be randomized into intervention and control groups. The intervention group will receive nurse led DSME using the American Association of diabetes educators 7 self care behaviour over a 6 month period. It will involve 3 monthly in-person sessions starting from the first day of recruitment as well as 2 weekly phone call sessions. This will be in addition to the usual care at the diabetes clinic.

The control group will receive usual diabetes care

Conditions

  • Diabete Type 2

Interventions

BEHAVIORAL

Intervention

The intervention group will receive the usual consultation from their doctor and referral to a diabetes educator for individualised structured DSME training. A clinical sheet will be used while delivering the education to ensure that all core topics are covered. For this study, 2 diabetes educators will offer the individualised DSME sessions using the American Association of Diabetes Education (AADE) 7 self-care behaviour model. The participants are scheduled to attend a 1-hour individualised session at the hospital every 3 months as well as telephone consultations lasting up to 15 minutes every 2 weeks at the convenience of the participant to reinforce DSME for 6 months. The first session is arranged on the first day after consultation with the doctor. At the end of the sessions, the participants will receive a patient guide to diabetes booklet and graphic material illustrating several self-care activities such as foot care

Sponsors & Collaborators

  • Komfo Anokye Teaching Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-06
Primary Completion
2024-10-30
Completion
2024-10-30

Countries

  • Ghana

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07149311 on ClinicalTrials.gov