NCT05544435

Brief Summary

Purpose:This study aims to research the effects of motivational interviewing on self-care activities in patients with type 2 diabetes. Design and Method:This study is a quasi-experimental clinical research with pre-test post-test comparison.12 sessions were held in 3 months in the experimental group with motivational interviewing method. Findings:After a 3-month follow up, while a significant improvement was observed in post-intervention self-care activities in the experimental group, a significant decrease was observed in all self-care activities except foot care in the control group. Practice Implications:Motivational interviewing intervention can be used to develop self-care activities in type 2 diabetes patients, especially to guide diabetes nurses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable diabetes-mellitus-type-2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

September 1, 2022

Last Update Submit

September 15, 2022

Conditions

Keywords

Motivational İnterviewingNursingSelf-caring activitiesTurkey

Outcome Measures

Primary Outcomes (1)

  • Summary of diabetes self-care activities scale (SDSCA)

    Summary of diabetes self-care activities scale consists of patient diet, exercise, blood sugar test, foot care and smoking.

    3 months after the start of the study

Secondary Outcomes (1)

  • Metabolic variable values

    3 months after the start of the study

Study Arms (1)

Motivational Interviewing

EXPERIMENTAL

Intervention In addition to the care they always received, MI sessions were conducted by the researcher for the participants in the experimental group. This intervention was conducted as 30-45 minutes of 12 sessions in total for each patient for a period of 3 months by the academic nurse. In these sessions, the agenda was created in accordance with the nature of MI intervention, efforts were made to resolve the ambivalent feelings in the patient, the patient's change phase was determined, the patient's self-confidence for change was determined, it was questioned how much the patient cared for change and the patient was helped in determining the change plan. In addition, during the sessions, the problems patients experienced about self-care activities, the causes of these problems and the barriers in maintaining self-care activities were discussed and efforts were made to create awareness in patients.

Behavioral: Motivational İnterviewing

Interventions

Motivational Interviewing (MI), which is one of these methods, is an individual-based counselling approach that can easily be used by nurses who have been trained to help the management of disease in chronic diseases (Berhe et al., 2020; Kızılırmak \& Demir, 2018; Maslakpak et al., 2020). The core principles of MI includes expressing empathy by providing acceptance and understanding, realizing inconsistencies, avoiding discussions and supporting self-efficacy (Matinolli et al., 2012). The main purpose of MI is to identify the ambivalent emotions that occur in the patient in health-related activities, to strengthen and encourage insights of patients by supporting healthy lifestyle changes and self-confidence (R.Miller \& Rollnick, 2013). Because of its flexibility and ability to be applied in different behavioural aspects, MI can be administered individually and in groups by trained individuals (Maslakpak et al., 2020).

Motivational Interviewing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 and older
  • Diagnosed with T2DM at least six months ago
  • To be literate
  • Living in the city centre
  • HbA1c value of 6.5% or higher
  • Speak Turkish.

You may not qualify if:

  • Having any psychiatric disease and mental problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum Technical University Faculty

Erzurum, 25050, 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

  • Elanur Uludağ, Dr.

    Erzurum Technical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 16, 2022

Study Start

September 25, 2019

Primary Completion

May 30, 2020

Study Completion

May 30, 2020

Last Updated

September 16, 2022

Record last verified: 2022-09

Locations