NCT05844748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

December 5, 2022

Last Update Submit

April 25, 2023

Conditions

Keywords

Diabetes MellitusSelf-efficacyAdaptation to illnessBehavior changeMotivational interview

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 mounth

Study Arms (1)

diabetes education with motivational interview technique

EXPERIMENTAL

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.

Other: diabetes education with motivational interview technique

Interventions

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.

Also known as: general method of diabetes education
diabetes education with motivational interview technique

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Being younger than 18 years of age
  • Being at the age of 65 or older
  • Reluctance to participate in the research.
  • Type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Istanbul, Üsküdar, 34000, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
39 participants are in the intervention group and 39 participants are in the control group.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Motivational Interviewing Technique
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist diabetes nurse

Study Record Dates

First Submitted

December 5, 2022

First Posted

May 6, 2023

Study Start

February 1, 2022

Primary Completion

September 30, 2022

Study Completion

December 1, 2022

Last Updated

May 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

This study, which was planned and carried out as a doctoral thesis, will be published scientifically after the completion of the research.

Shared Documents
CSR
Time Frame
2024-2025
Access Criteria
This study will be shared with nurses giving care to diabetes patients and aims to benefit type 2 diabetes patients
More information

Locations