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The Effectiveness of Diabetes Self-Management Education Program Based on Behavioural Change Theory

NCT02699541 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2017-08-15

No results posted yet for this study

Summary

In this study, researchers will test the effectiveness of a self-management education programme, on self-management behaviours of patients with type two diabetes. Up to 230 consenting participants will be recruited from outpatient diabetes clinics in Jordan, 230 participants will be randomised to one of two groups. Group 1 ( 115 patients) have received the intervention, which consisted of an introductory session of tailored, face-to-face education and advice, followed by educational materials to take away, and regular telephone support at a regularity specified by the patient, over a three-month period. This intervention is based on behavioural change theory called the Information-Motivational-Behavioural skills model. Group 2 (115 patients) have received usual clinical care with no additional intervention. Researchers have assessed the effectiveness of the intervention by measuring self-care strategies (dietary habits, physical activity and managing diabetes medications), diabetes control (HbA1c), quality of life and Diabetes Self-Management Knowledge, Motivation and Self-Efficacy at 3 time points: before the intervention, at 3 months and at 6 months.

Conditions

  • Health Behavior
  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

Diabetes Self-Management Education

This study will implement an individualized DSME program based on Information-Motivation-Behavioral (IMB) skills theory. IMB behavioral change theory assumption proposes that health-related behavior information, motivation and behavioural skills are primary determinants of promoting health behavior. Researcher will use a previously validated educational toolkit (PRIDE) and will be delivered using motivational interviewing techniques through several sessions for each participant. Two face-to-face sessions (one at the beginning and one at the end of the 3 month period) and one phone call per week or per fortnight.

Sponsors & Collaborators

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Holly Blake, PhD · University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-10-31
Completion
2017-01-18

Countries

  • Jordan

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 NCT02699541 on ClinicalTrials.gov