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Motivational Interviewing in Type 2 Diabetes Patients

Primary Purpose

Diabetes Mellitus, Type 2, Motivation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
diabetes education with motivational interview technique
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Self-efficacy, Adaptation to illness, Behavior change, Motivational interview

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

diabetes education with motivational interview technique

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2022
Last Updated
April 25, 2023
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05844748
Brief Title
Motivational Interviewing in Type 2 Diabetes Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Motivation
Keywords
Diabetes Mellitus, Self-efficacy, Adaptation to illness, Behavior change, Motivational interview

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Motivational Interviewing Technique
Masking
None (Open Label)
Masking Description
39 participants are in the intervention group and 39 participants are in the control group.
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diabetes education with motivational interview technique
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
diabetes education with motivational interview technique
Other Intervention Name(s)
general method of diabetes education
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
3 mounth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Health Sciences
City
Istanbul
State/Province
Üsküdar
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://tez.yok.gov.tr/
Links:
URL
https://dergipark.org.tr/en/download/article-file/752953
Description
Tip 2 Diyabet Tanılı Yetişkinlerde Motivasyonel Görüşmenin Etkisi: Sistematik Derleme *
URL
https://dergipark.org.tr/tr/download/article-file/115235
Description
Tip 2 Diabetes Mellitus'ta Sağlık Davranış Değişiminde Transteoretik Model Temelli Motivasyonel Görüşme Tekniği

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Motivational Interviewing in Type 2 Diabetes Patients

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