NCT05187806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2017

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
Last Updated

January 12, 2022

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

December 8, 2021

Last Update Submit

December 24, 2021

Conditions

Keywords

type 2 diabetesmotivational interviewingHbA1cself management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Comparison of the pretest-posttest HbA1c values

    3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

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.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details18 years and older
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Having a perception disorder that will prevent communication
  • Having been diagnosed with any mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health, Gaziosmanpasa Training and Research Hospital

Istanbul, 34255, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Deniz Kaya Meral, Phd

    Ministry of Health, Gaziosmanpasa Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Without knowing that participants are in the experimental or control group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 8, 2021

First Posted

January 12, 2022

Study Start

February 7, 2017

Primary Completion

May 7, 2017

Study Completion

December 7, 2017

Last Updated

January 12, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

There is no plan to share to Individual participant data

Locations