- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05919706
Mobile Technology and Motivational Interviewing in Type 2 Diabetes Patients
June 24, 2023 updated by: Nermin Kılıç Barmanpek, Inonu University
The Effect of Motivational Interview Empowered by Mobile Technology on Self Management, Quality of Life and Satisfaction Level in Type 2 Diabetic Patients
Type 2 diabetes patients were divided into experimental and control groups.
Patients in the control group received regular nursing care, while those in the experimental group received MI, which is empowered by game-based mobile technology.
Pre-test, post-test and follow-up test self-management, quality of life and satisfaction levels scores were determined.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomized controlled and experimental study design was used to conduct this research on 64 patients with Type 2 DM.
Purpose of this study was to explore how motivational interviewing powered by game-based mobile technology affected self-management, quality of life, and satisfaction in Type 2 diabetes patients.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Centrer
-
Bingöl, Centrer, Turkey
- Bingol State Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being 18 years or older,
- Having a diagnosis of Type 2 Diabetes Mellitus according to the ADA diagnostic criteria,
- Being on oral antidiabetic and/or insulin therapy,
- Having a smart phone and knowing how to use it,
- Internet connection (to install mobile technology application),
- Not having participated in motivational interviewing (MG) training before,
- Not having vision and hearing problems,
- Not having a communication problem,
- To be able to read, write and speak Turkish,
- Volunteering to participate in the study and continue the study process.
Exclusion Criteria:
- Having a diagnosis of Type 1 and/or Gestational Diabetes Mellitus,
- Having serious health problems that prevent participation in motivational interviewing,
- Using steroid therapy,
- Having complications that may develop in the long term due to diabetes and having advanced retinopathy, neuropathy, amputation history or active foot wound,
- Having mental confusion, having any psychiatric problems and/or using a psychiatric drug,
- Being unwilling to participate in the study and/or not wanting to continue the study process.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
Pre-test data were collected from patients with Patient Information and Follow-up Form, Diabetes Self-Management Scale (DSMQ) and Short Form-36 Quality of Life Scale (SF-36).
After the pre-test, a educational program and a game-based mobile technology application were carried out for 4 weeks, 2 days a week at intervals.
After the educational program were completed, motivational interviews were conducted once a week for 4 weeks.
In this process, it was ensured that the game-based mobile technology application continued.
Post-test data were collected with DSMQ and SF-36 at 2 months (8 weeks after the pre-test).
After the post-test, the patients were followed up for 4 weeks.
After the follow, with the Patient Information and Follow-up Form, DSMQ, SF-36, and the Satisfaction Questionnaire the follow-test data was collected.
|
Education program, game-based mobile technology and motivational interview were applied to the patients in the experimental group.
The patients' self-management, quality of life, and satisfaction level scores for the intervention were determined.
|
No Intervention: Control Group
Pre-test data were collected from patients with Patient Information and Follow-up Form, Diabetes Self-Management Scale DSMQ) and Short Form-36 Quality of Life Scale (SF-36).
After the pre-test data were collected, no intervention was applied to the patients for 3 months (12 weeks), except for routine nursing care.
Posttest data were collected with DSMQ and SF-36 2 months (8 weeks) after the pretest data.
After the last test, the patients were followed up for 4 weeks, and 3 months (12 weeks) after the start of the study, the Patient Information and Follow-up Form (only the parts containing the features related to the disease and metabolic control variables), DSMQ and SF-36 Scale and follow-up test data were collected.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DSMQ
Time Frame: Last 8 weeks
|
The scale is of a four-point Likert type.
The scale has 4 sub-dimensions as "Glucose Management, Diet Control, Physical Activity, Health-Care Use" and a total score.
The lowest score of the scale is 0 points and the highest score is 10 points.
The higher the score, the higher the diabetes self-management.
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Last 8 weeks
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SF-36
Time Frame: Last 4 weeks
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The scale consists of 36 items and 8 sub-dimensions.
8 sub-dimensions have 2 summary sub-dimensions as "Physical Health and Mental Health".
There is no total score in the scale.
A score between 0-100 is evaluated with sub-dimensions (0: Poor Health, 100: Good Health).
Low scores on the scale indicate poor health, while high scores indicate good health.
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Last 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 6, 2022
Primary Completion (Actual)
February 3, 2023
Study Completion (Actual)
February 3, 2023
Study Registration Dates
First Submitted
June 13, 2023
First Submitted That Met QC Criteria
June 13, 2023
First Posted (Actual)
June 26, 2023
Study Record Updates
Last Update Posted (Actual)
June 27, 2023
Last Update Submitted That Met QC Criteria
June 24, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Diabetes Mellitus and Mobile
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Can be reviewed by other researchers after the study has been published.
IPD Sharing Time Frame
Data will be shared as long as they are published.
IPD Sharing Access Criteria
Publication Page
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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