Mobile Technology and Motivational Interviewing in Type 2 Diabetes Patients

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Patient Education with Game-Based Mobile Technology and Motivational Interviewing

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes, Self-Management, Quality of Life, Satisfaction, Nursing, Mobile Technology, Gaming, Motivational Interviewing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

Bingol State Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05919706

First Posted

June 13, 2023

Last Updated

June 24, 2023

Sponsor

Inonu University

1. Study Identification

Unique Protocol Identification Number

NCT05919706

Brief Title

Mobile Technology and Motivational Interviewing in Type 2 Diabetes Patients

Official Title

The Effect of Motivational Interview Empowered by Mobile Technology on Self Management, Quality of Life and Satisfaction Level in Type 2 Diabetic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

October 6, 2022 (Actual)

Primary Completion Date

February 3, 2023 (Actual)

Study Completion Date

February 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

Detailed Description

A randomized controlled and experimental study design was used to conduct this research on 64 patients with Type 2 DM. Purpose of this study was to explore how motivational interviewing powered by game-based mobile technology affected self-management, quality of life, and satisfaction in Type 2 diabetes patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Gaming, Motivational Interviewing, Self-Management, Quality of Life, Mobile Technology

Keywords

Type 2 Diabetes, Self-Management, Quality of Life, Satisfaction, Nursing, Mobile Technology, Gaming, Motivational Interviewing

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This study was conducted as a randomized controlled experimental study with pretest-posttest-follow-up test.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Patient Education with Game-Based Mobile Technology and Motivational Interviewing

Intervention Description

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.

Primary Outcome Measure Information:

Title

DSMQ

Description

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.

Time Frame

Last 8 weeks

Title

SF-36

Description

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.

Time Frame

Last 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Facility Information:

Facility Name

Bingol State Hospital

City

Bingöl

State/Province

Centrer

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

IPD Sharing Time Frame

Data will be shared as long as they are published.

IPD Sharing Access Criteria

Publication Page

IPD Sharing URL

https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp

Type 2 Diabetes Mellitus, Gaming, Motivational Interviewing

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial