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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05187806
Other study ID # NursePsychiatric
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 7, 2017
Est. completion date December 7, 2017

Study information

Verified date December 2021
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 7, 2017
Est. primary completion date May 7, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Turkey Ministry of Health, Gaziosmanpasa Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months
Secondary 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. 3 months
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