Diabetes Mellitus, Type 2NCT05844748
Motivational Interviewing in Type 2 Diabetes Patients
A study testing diabetes education with motivational interview technique in people with Diabetes Mellitus, Type 2 and Motivation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Motivation
- What is being tested?
- diabetes education with motivational interview technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Being younger than 18 years of age
- Being at the age of 65 or older
- Reluctance to participate in the research.
- Type 1 diabetes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Istanbul, Üsküdar, 34000
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Motivation
- Being tested
- diabetes education with motivational interview technique
- Keywords
- Diabetes Mellitus, Self-efficacy, Adaptation to illness, Behavior change, Motivational interview
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diabetes education with motivational interview techniqueOther
Also called general method of diabetes education
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: diabetes education with motivational interview technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Feb 2022
- Primary completion30 Sep 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Motivational Interviewing Technique
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan Yurtsever, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844748
- Sponsor's protocol ID
- SYURTSEVER
- Status last verified
- Apr 2023
- First submitted
- 5 Dec 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study, which was planned and carried out as a doctoral thesis, will be published scientifically after the completion of the research.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05844748
- Acronym / sponsor ID
- SYURTSEVER
- Conditions
- Diabetes Mellitus, Type 2, Motivation
- Keywords
- Diabetes Mellitus, Self-efficacy, Adaptation to illness, Behavior change, Motivational interview
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Motivational Interviewing Technique
| Arm | Type | Receives |
|---|---|---|
| diabetes education with motivational interview technique | Experimental | Other: diabetes education with motivational interview techniqueA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Being younger than 18 years of age
- Being at the age of 65 or older
- Reluctance to participate in the research.
- Type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diabetes education with motivational interview techniqueAlso: general method of diabetes educationTechniques 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 | diabetes education with motivational interview technique |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Tip 2 Diyabet Tanılı Yetişkinlerde Motivasyonel Görüşmenin Etkisi: Sistematik Derleme \*Link provided by the sponsor.
- Tip 2 Diabetes Mellitus'ta Sağlık Davranış Değişiminde Transteoretik Model Temelli Motivasyonel Görüşme TekniğiLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. This study, which was planned and carried out as a doctoral thesis, will be published scientifically after the completion of the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diabetes education with motivational interview technique in people with Diabetes Mellitus, Type 2 and Motivation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.