NCT05919706

Brief Summary

Type 2 diabetes patients were divided into experimental and control groups. Patients in the control group received regular nursing care, while those in the experimental group received MI, which is empowered by game-based mobile technology. Pre-test, post-test and follow-up test self-management, quality of life and satisfaction levels scores were determined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

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

Timeline
Completed

Started Oct 2022

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

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

October 6, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

June 13, 2023

Last Update Submit

June 24, 2023

Conditions

Keywords

Type 2 DiabetesSelf-ManagementQuality of LifeSatisfactionNursingMobile TechnologyGamingMotivational Interviewing

Outcome Measures

Primary Outcomes (2)

  • DSMQ

    The scale is of a four-point Likert type. The scale has 4 sub-dimensions as "Glucose Management, Diet Control, Physical Activity, Health-Care Use" and a total score. The lowest score of the scale is 0 points and the highest score is 10 points. The higher the score, the higher the diabetes self-management.

    Last 8 weeks

  • SF-36

    The scale consists of 36 items and 8 sub-dimensions. 8 sub-dimensions have 2 summary sub-dimensions as "Physical Health and Mental Health". There is no total score in the scale. A score between 0-100 is evaluated with sub-dimensions (0: Poor Health, 100: Good Health). Low scores on the scale indicate poor health, while high scores indicate good health.

    Last 4 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Pre-test data were collected from patients with Patient Information and Follow-up Form, Diabetes Self-Management Scale (DSMQ) and Short Form-36 Quality of Life Scale (SF-36). After the pre-test, a educational program and a game-based mobile technology application were carried out for 4 weeks, 2 days a week at intervals. After the educational program were completed, motivational interviews were conducted once a week for 4 weeks. In this process, it was ensured that the game-based mobile technology application continued. Post-test data were collected with DSMQ and SF-36 at 2 months (8 weeks after the pre-test). After the post-test, the patients were followed up for 4 weeks. After the follow, with the Patient Information and Follow-up Form, DSMQ, SF-36, and the Satisfaction Questionnaire the follow-test data was collected.

Behavioral: Patient Education with Game-Based Mobile Technology and Motivational Interviewing

Control Group

NO INTERVENTION

Pre-test data were collected from patients with Patient Information and Follow-up Form, Diabetes Self-Management Scale DSMQ) and Short Form-36 Quality of Life Scale (SF-36). After the pre-test data were collected, no intervention was applied to the patients for 3 months (12 weeks), except for routine nursing care. Posttest data were collected with DSMQ and SF-36 2 months (8 weeks) after the pretest data. After the last test, the patients were followed up for 4 weeks, and 3 months (12 weeks) after the start of the study, the Patient Information and Follow-up Form (only the parts containing the features related to the disease and metabolic control variables), DSMQ and SF-36 Scale and follow-up test data were collected.

Interventions

Education program, game-based mobile technology and motivational interview were applied to the patients in the experimental group. The patients' self-management, quality of life, and satisfaction level scores for the intervention were determined.

Experimental Group

Eligibility Criteria

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

You may qualify if:

  • Being 18 years or older,
  • Having a diagnosis of Type 2 Diabetes Mellitus according to the ADA diagnostic criteria,
  • Being on oral antidiabetic and/or insulin therapy,
  • Having a smart phone and knowing how to use it,
  • Internet connection (to install mobile technology application),
  • Not having participated in motivational interviewing (MG) training before,
  • Not having vision and hearing problems,
  • Not having a communication problem,
  • To be able to read, write and speak Turkish,
  • Volunteering to participate in the study and continue the study process.

You may not qualify if:

  • Having a diagnosis of Type 1 and/or Gestational Diabetes Mellitus,
  • Having serious health problems that prevent participation in motivational interviewing,
  • Using steroid therapy,
  • Having complications that may develop in the long term due to diabetes and having advanced retinopathy, neuropathy, amputation history or active foot wound,
  • Having mental confusion, having any psychiatric problems and/or using a psychiatric drug,
  • Being unwilling to participate in the study and/or not wanting to continue the study process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bingol State Hospital

Bingöl, Centrer, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Personal Satisfaction

Interventions

Patient Education as TopicMotivational Interviewing

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDirective CounselingCounselingMental Health ServicesBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was conducted as a randomized controlled experimental study with pretest-posttest-follow-up test.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 26, 2023

Study Start

October 6, 2022

Primary Completion

February 3, 2023

Study Completion

February 3, 2023

Last Updated

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Can be reviewed by other researchers after the study has been published.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will be shared as long as they are published.
Access Criteria
Publication Page
More information

Locations