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Motivational Interviewing With Diabetes Patients

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
motivational interview
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes focused on measuring type 2 diabetes, motivational interviewing, HbA1c, self management

Eligibility Criteria

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

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

Sites / Locations

  • Ministry of Health, Gaziosmanpasa Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Comparison of the pretest-posttest Diabetes Self-management Instrument-35 scores
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.

Secondary Outcome Measures

Comparison of the pretest-posttest HbA1c values
The pretest and posttest HbA1c values of the patients in the experimental and control groups were compared in the third month.

Full Information

First Posted
December 8, 2021
Last Updated
December 24, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05187806
Brief Title
Motivational Interviewing With Diabetes Patients
Official Title
Effects of Motivational Interviewing Intervention on Self- Management and HbA1c in Type 2 Diabetes Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 7, 2017 (Actual)
Primary Completion Date
May 7, 2017 (Actual)
Study Completion Date
December 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
type 2 diabetes, motivational interviewing, HbA1c, self management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Without knowing that participants are in the experimental or control group
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
motivational interview
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of the pretest-posttest Diabetes Self-management Instrument-35 scores
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Comparison of the pretest-posttest HbA1c values
Description
The pretest and posttest HbA1c values of the patients in the experimental and control groups were compared in the third month.
Time Frame
3 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
18 years and older
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz Kaya Meral, Phd
Organizational Affiliation
Ministry of Health, Gaziosmanpasa Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ministry of Health, Gaziosmanpasa Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34255
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share to Individual participant data

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Motivational Interviewing With Diabetes Patients

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