Motivational Interviewing With Diabetes Patients

Sponsor

Istanbul University-Cerrahpasa (Other)

Overall Status

Completed

CT.gov ID

NCT05187806

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Behavioral: motivational interview	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Without knowing that participants are in the experimental or control group

Primary Purpose:

Supportive Care

Official Title:

Effects of Motivational Interviewing Intervention on Self- Management and HbA1c in Type 2 Diabetes Patients

Actual Study Start Date :

Feb 7, 2017

Actual Primary Completion Date :

May 7, 2017

Actual Study Completion Date :

Dec 7, 2017

Arms and Interventions

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.	Behavioral: motivational interview 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.
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.

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.

Behavioral: motivational interview

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison of the pretest-posttest HbA1c values [3 months]
The pretest and posttest HbA1c values of the patients in the experimental and control groups were compared in the third month.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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