- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05844748
Motivational Interviewing in Type 2 Diabetes Patients
April 25, 2023 updated by: Sultan Yurtsever, Saglik Bilimleri Universitesi
The Effect of Training Using Motivational Interview Technique in Type 2 Diabetes Patients on Perceived Self-Efficacy, Level of Adaptation to Disease and Metabolic Parameters
This research was planned to examine the effects of diabetes education given by motivational interviews on adherence to the disease, perception of diabetes self-efficacy and metabolic parameters in diabetes patients.
The research sample will consist of 78 individuals with type 2 diabetes (39 intervention group - 39 control group).
Diabetes education will be given to the participants in the intervention (experimental) group of the research with the motivational interview method based on the Transtheoretic Model.
The interviews will be completed at the end of 2 months, with a total of 6 sessions in the first month (4 sessions per month) and once every 15 days in the 2nd month (2 sessions per month).
Participants in the control group will be given standard diabetes education.
Participants in the intervention (experimental) and control groups will be asked to follow the habit of exercising regularly and blood sugar.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To the participants in the intervention group of the research; Diabetes education will be given by using the motivational interview method, which is structured on the basis of the Transtheoretic Model.
Data will be obtained by face-to-face interview method individually.
Information will be obtained from the following forms as a pre-test for the participants in the initiative group:Patient Information Form [App.
1], Behavioral Change Stage Diagnosis Form in Patients with Type 2 Diabetes [App.
2], Diabetes Self-Efficacy Perception Scale [App.
3], Chronic Disease Adjustment Scale [App.
4].
Metabolic parameters of patients before the motivational interview Metabolic Results It will be recorded in the Follow-up Form (HbA1c, FCC, HDL cholesterol, LDL cholesterol, Triglyceride, Total Cholesterol, Height, Weight, BMI) [App.
5].Diabetes education will be given to the intervention (experimental) group using the motivational interview method consisting of 6 sessions.
The interviews will be completed at the end of 2 months, with a total of 6 sessions in the first month (4 sessions per month) and once every 15 days in the 2nd month (2 sessions per month).
The participants in the intervention group will be given a Blood Glucose Follow-up Chart [App.
6] at the first meeting, and they will be asked to bring the Blood Glucose Follow-up Chart with them at each meeting (6 times in total), by writing the follow-up result.
After explaining the positive effect of exercise on blood glucose to the participants in the intervention group, the Walking Program Implementation Chart will be given.
Participants will be asked to record the total number of steps per day, together with the date they walked, the number of steps taken during walking, and any complaints experienced, and bring them together in each motivational interview session (6 times in total).In the first interview, the researcher will provide and give the individual the Walking Program Implementation Chart, along with the pedometer that they will use to track the number of steps in their daily activities.
In each motivational interview session, the individual's daily step counts will be checked.
At the end of the first session, the participants in the intervention group will be given the "Educational Guide for Individuals with Diabetes" booklet, which will be prepared by the researcher.
Participants in the intervention group will be informed by the researcher via reminder phone messages (SMS) once a week (6 times in total) to exercise regularly.As a post-test for the participants in the intervention group; Patient Information Form [App 8], Behavior Change Stage Diagnosis Form in Patients with Type 2 Diabetes [App.
2], Diabetes Self-Efficacy Perception Scale [App.
3], Chronic Disease Adjustment Scale [App.
4].
Diabetes education of the participants in the intervention group using motivational interview method Blood glucose and lipid profile will be monitored as metabolic parameters and recorded in the Metabolic Results Follow-up Form [App.
5] at the 3rd month after completion.
The height and weight follow-up of the participants in the intervention group will be done again in the 3rd month after the end of the motivational interview sessions and recorded in the Metabolic Results Follow-up Form [App.
5] by the researcher.As a pre-test before starting the general diabetes education among the participants in the control group; Patient Information Form [App.
1], Behavioral Change Stage Diagnosis Form in Patients with Type 2 Diabetes [App.
2], Diabetes Self-Efficacy Scale [App.
3], Chronic Disease Adjustment Scale [App.
4] will be used.Metabolic Results (HbA1c, FCC, HDL, LDL, Triglyceride, Total Cholesterol, Height, Weight and BMI) Follow-up Form [App.
6], Individual general diabetes education lasting 30-60 minutes on average will be given to the participants in the control group.
At the 3rd month after general diabetes education, participants in the control group will be asked to complete the posttests again (App.
2,3,4,8).
The metabolic parameters of the participants in the control group will be monitored in the 3rd month and recorded by the researcher.
Study Type
Interventional
Enrollment (Actual)
78
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
-
-
Üsküdar
-
Istanbul, Üsküdar, Turkey, 34000
- University of Health Sciences
-
-
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
Yes
Description
Inclusion Criteria:
- Must be over the age of 18 and under 65.
- Must be diagnosed with diabetes type 2 and treated for more than 6 months
- Must able to understand and speak Turkish.
- Must volunteer to participate in the research.
Exclusion Criteria:
- Being younger than 18 years of age
- Being at the age of 65 or older
- Reluctance to participate in the research.
- Type 1 diabetes
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: diabetes education with motivational interview technique
A face-to-face motivational interview session was applied to each participant in the experimental (intervention) group by the researcher once a week in the 1st month and once in 15 days in the 2nd month.
The interviews were held in 6 sessions in total, and each interview was completed in approximately 45-60 minutes.
|
Techniques such as developing empathy, developing disengagement, turning with resistance, supporting self-efficacy, avoiding advice, a simple decision, importance-trust scale, open-ended questions, reflection and segmentation in motivational interviews.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Effect of Training Given by Motivational Interview Technique on Self-Efficacy Perception, Level of Adjustment to Disease and Metabolic Parameters in Type 2 Diabetes Patients
Time Frame: 3 mounth
|
After diabetes education given by motivational interviews It is expected that there will be an increase in the level of self-efficacy and compliance with the disease, and an improvement in metabolic parameters in patients.
|
3 mounth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
February 1, 2022
Primary Completion (Actual)
September 30, 2022
Study Completion (Actual)
December 1, 2022
Study Registration Dates
First Submitted
December 5, 2022
First Submitted That Met QC Criteria
April 25, 2023
First Posted (Estimate)
May 4, 2023
Study Record Updates
Last Update Posted (Estimate)
May 4, 2023
Last Update Submitted That Met QC Criteria
April 25, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYURTSEVER
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
This study, which was planned and carried out as a doctoral thesis, will be published scientifically after the completion of the research.
IPD Sharing Time Frame
2024-2025
IPD Sharing Access Criteria
This study will be shared with nurses giving care to diabetes patients and aims to benefit type 2 diabetes patients
IPD Sharing Supporting Information Type
- 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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