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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: diabetes education with motivational interview technique
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:
  • general method of diabetes education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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