NCT06769477

Brief Summary

This study aims to examine the effects on diabetes self-management, health fatalism and metabolic parameters of individuals with type 2 diabetes. The study will be conducted in a health institution between February 2025 and May 2025 and participants will be assigned to experimental and control groups by simple random sampling method. The experimental group will be trained with motivational interviewing techniques based on the health belief model for 8 weeks, followed by sending reminder SMS for 4 weeks. The control group will receive no intervention. The study is expected to improve the self-care behaviors of individuals with diabetes by creating positive effects on diabetes management and health fatalism.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

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

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

2 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

January 7, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

January 7, 2025

Last Update Submit

February 23, 2025

Conditions

Keywords

health belief modelmotivational interviewself-managementhealth fatalismtype 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Type 2 DM Self-Management Scale (SMS)

    The scale assesses self-management It has 3 sub-dimensions.These dimensions consist of 11 questions consisting of "Healthy Lifestyle Behaviors" dimension, consisting of 4 questions "Health Services Utilization" dimension and "Blood Sugar Management" dimension. Scoring: Always 5, Often 4, Sometimes 3, Rarely 2, Never 1. (-Healthy Lifestyle Subdimension= HLBD-1+ HLBD-2+ HLBD-3+ HLBD-4+ HLBD-5+ HLBD-6+ HLBD-7+ SYBD-8+ SYBD-9+ SYBD-10+ SYBD-11.) (-Blood Glucose Management Subscale= BSM-1+ BSM-2+ BSM-3+ BSM-4) (-Health Services Utilization Subdimension= SHK-1+ SHK-2+ SHK-3+ SHK-4) (-Diabetes Self-Management Scale score=SMDI Subdimension+CSM Subdimension +SCC Subdimension.) There are no reverse items in the scale. High scores indicate good self-management, low scores indicate and poor self-management. The minimum score that can be obtained from the Type 2 self-management scale is 19 and the maximum score is 95.

    three months

Secondary Outcomes (1)

  • Health Fatalism Scale

    three months

Study Arms (2)

group receiving diabetes education with motivational interviewing technique

ACTIVE COMPARATOR

Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be applied to the experimental group before the training. then, diabetes education will be given to the individuals in the experimental group one day a week with the motivational interviewing technique based on the health belief model. 8 weeks of training will be given in total and then 4 weeks of informative reminder sms will be sent about diabetes education. After the training is over, Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be applied.

Other: Experimental Group

group with no intervention

NO INTERVENTION

The control group will be administered the Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale at the first encounter. After 3 months, the Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be applied again. No application will be made to the control group.

Interventions

individuals will receive diabetes education with motivational interviewing technique based on health belief model

group receiving diabetes education with motivational interviewing technique

Eligibility Criteria

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

You may qualify if:

  • Having type 2 diabetes for at least 6 months
  • To be over 18 years old
  • Have sufficient communication skills to answer verbal and written questions and fulfill instructions
  • Becoming literate
  • No physical, cognitive or mental impairment in answering the questions
  • Willingness to participate in research.

You may not qualify if:

  • Under 18 years of age
  • Being hospitalized in inpatient treatment institutions due to DM or DM complications during the research process
  • The emergence of any health problem that prevents the person from continuing the research
  • Do not leave the study voluntarily.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Manavgat and Aksu Family Health Center

Antalya, 07000, Turkey (Türkiye)

RECRUITING

Manavgat and Aksu Family Health Center

Antalya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Gülşen Altuntaş Çalım, PhD student

CONTACT

Cantürk Çapık, Prof. dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: the experimental group will be trained with motivational technique. the control group will not receive any intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
health services teacher in the ministry of national education

Study Record Dates

First Submitted

January 7, 2025

First Posted

January 10, 2025

Study Start

February 1, 2025

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations