The Effectiveness of Diabetes Self-Management Education Program Based on Behavioural Change Theory
IMB-DSME
The Effectiveness of Information-Motivation-Behavioural Skills Model-based Diabetes Self-Management Education Among Patients With Type 2 Diabetes in Jordan
1 other identifier
interventional
151
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2016
CompletedFirst Posted
Study publicly available on registry
March 4, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2017
CompletedAugust 15, 2017
August 1, 2017
6 months
February 17, 2016
August 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participants' diabetes self-Management activities: diet habits, physical activity and medications Management
The primary outcome will be diabetes self-management activities and will be measured by two scales; Summary of Diabetes self-care activities scale (SDSCA) and Medications Adherence Rating Scale (MARS) for each participant. Both of them will assess participants' response each by units on a scale, and each participant will have a total score calculated by summing SDSCA score and MARS score.
6 months
Secondary Outcomes (7)
Participants' glycaemic level.
6 months
Participants' weight.
6 months
Participants' blood pressure
6 months
Participants' quality of life.
6 months
Diabetes Self-Management Knowledge
6 months
- +2 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALIntervention group participants will receive the educational intervention based on the Information, Motivational, Behavioral change model.
Control group
NO INTERVENTIONControl group participants will receive usual care treatment and referral to diabetes educational consultation if required.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Any age from 18 to 65 years.
- Access to a telephone whether mobile phone or land line phone (cable).
- Capable to give informed consent for themselves as well as being able to communicate, read, write and understand Arabic language in order to complete self-report outcomes questionnaires and interpret the study booklet.
- Experiencing uncontrolled glycaemic level (HbA1c \>8%) at the day of visiting the clinic.
You may not qualify if:
- Patients who suffer from any cognitive impairment or any disease condition or taking medication that affects their memory (self-reported by patient and/or companion).
- Pregnant women because they require a specific treatment intervention due to the differences in metabolic outcomes cut off points.
- Patients who anticipate they will be admitted to the hospital during study period.
- Currently attending or have attended any diabetes education program in the last 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jordan University Hospital
Amman, Jordan
Prince Hamzeh Hospital
Amman, Jordan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Holly Blake, PhD
University of Nottingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2016
First Posted
March 4, 2016
Study Start
April 1, 2016
Primary Completion
October 1, 2016
Study Completion
January 18, 2017
Last Updated
August 15, 2017
Record last verified: 2017-08