- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05187806
Motivational Interviewing With Diabetes Patients
December 24, 2021 updated by: Deniz KAYA MERAL, Istanbul University-Cerrahpasa
Effects of Motivational Interviewing Intervention on Self- Management and HbA1c in Type 2 Diabetes Patients
This study was conducted in a quasi-experimental research design with a pretest-posttest control group to determine the effect of motivational interviewing on self-management and HbA1c in patients with type 2 diabetes.
The sample of the study consisted of 25 experimental and 26 controls, who applied to an outpatient clinic in a training and research hospital.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study was conducted in a quasi-experimental research design with a pretest-posttest control group to determine the effect of motivational interviewing on self-management and HbA1c in patients with type 2 diabetes.
The sample of the study consisted of 25 experimental and 26 controls, who applied to an outpatient clinic in a training and research hospital.
After the pretest, the experimental group was intervened with a motivational interview (MI) method that consisted of four sessions; the control group received routine treatment.
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
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Istanbul, Turkey, 34255
- Ministry of Health, Gaziosmanpasa Training and Research Hospital
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years and older
- Having been diagnosed with type 2 diabetes for more than 3 months
- Being in the contemplation
- Preparation, and/or action stages of any section of the Behavioral Change Stage Identification Form of the Trans-Theoretical Model
- Having HbA1c levels above 6
- Agreeing to take part in the study
Exclusion Criteria:
- Having a perception disorder that will prevent communication
- Having been diagnosed with any mental disorder
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
After the pretest, the experimental group was intervened with a motivational interview (MI) method that consisted of four sessions of 30-60 (mean 45 min) min each.
The sessions were structured according to the Behavior Change Stage Identification Form developed by the researcher by making use of the trans-theoretical model and adapting it to diabetic patients.
The subject of the first session was "Opening, Structuring the Discussion, and Establishing the Agenda"; the subject of the second session was "Improving Motivation for Change"; the subject of the third session was "Summarizing, Support, and Talking about the Change"; and the subject of the fourth session was "Evaluation" .
The discussions were completed in four weeks, with one discussion held every week.
The final test and the Diabetes Self-Management Instrument were applied again to the members of the intervention group in the third month after completion of the MI method sessions.
|
After the pretest, the experimental group was intervened with a motivational interview (MI) method that consisted of four sessions.The pretest and posttest Diabetes Self-Management Scale total scores and HbA1c values of the patients in the experimental and control groups were compared.
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No Intervention: Control group
The control group received routine treatment.
The final test and the Diabetes Self-Management Instrument were applied again to the members of the control group in the third month.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the pretest-posttest Diabetes Self-management Instrument-35 scores
Time Frame: 3 months
|
The instrument is comprised of 35 questions covering the period from the previous three months to determine the frequency of the implementation of the self-management skills of the patients.
The total score for the Instrument ranged from 35 to 140.
A higher score showed that self-management activities were implemented on a more regular basis.
Interventions consisted of four sessions of 30-60 (mean 45 min) min each.
The sessions were structured according to the Behavior Change Stage Identification Form developed by the researcher by making use of the trans-theoretical model and adapting it to diabetic patients.The discussions were completed in four weeks, with one discussion held every week.
The final test and the Diabetes Self-Management Instrument were applied again to the members of the intervention group in the third month after completion of the MI method sessions and in the third month to the control group.
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the pretest-posttest HbA1c values
Time Frame: 3 months
|
The pretest and posttest HbA1c values of the patients in the experimental and control groups were compared in the third month.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Deniz Kaya Meral, Phd, Ministry of Health, Gaziosmanpasa Training and Research Hospital
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 7, 2017
Primary Completion (Actual)
May 7, 2017
Study Completion (Actual)
December 7, 2017
Study Registration Dates
First Submitted
December 8, 2021
First Submitted That Met QC Criteria
December 24, 2021
First Posted (Actual)
January 12, 2022
Study Record Updates
Last Update Posted (Actual)
January 12, 2022
Last Update Submitted That Met QC Criteria
December 24, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NursePsychiatric
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There is no plan to share to Individual participant data
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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