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The Effect of Gamification on Patients With Type 2 Diabetes

Primary Purpose

Gamification, Type 2 Diabetes, Self-management

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Gamification and education with mobile game application
Sponsored by
Sakarya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gamification

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Two years or more with a diagnosis of Type 2 DM Patients using Insulin or Insulin and Oral Antidiabetic No sensory loss, such as vision and hearing loss, Having internet access and being able to use it, Ability to use a mobile phone with an Android or IOS (iPhone OS) operating system Patients who agreed to participate in the study Exclusion Criteria: Patients diagnosed with Type 1 DM and Gestational DM. Visual and auditory loss, Individuals without internet access Unable to communicate

Sites / Locations

  • Pelin ILHANRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Application of data collection forms for the initial evaluation. Teaching the use of mobile games, monitoring the use of mobile games in the experimental group by the researcher for six weeks, and applying data collection forms to the patients in the sixth week.

Application of data collection forms for the initial evaluation. Application of data collection forms to the patients in the sixth week. No intervention will be made to the patients in the control group other than the routine education given in the diabetes outpatient clinic.

Outcomes

Primary Outcome Measures

self-management scale
Determining whether or not the disease self-management scale scores in patients with Type 2 DM using the developed mobile game application increased at the end of the 6 weeks period. A minimum of 0 and a maximum of 10 points are obtained on the scale. If an item is skipped, it is evaluated as -3 points. Diabetes self-management increases as the score get closer to 10.

Secondary Outcome Measures

glycemic control (HbA1c)
The effect that the mobile game application developed imposes on glycemic control in patients with Type 2 DM at six weeks compared to baseline. The effect of the patient's HbA1c tests on the 6th week compared to the baseline. Blood test (HbA1c) will be performed during the outpatient follow-up at the first and sixth weeks.
anthropometric measurements (Body Mass Index)
The effects on anthropometric measurements in patients with Type 2 DM using the mobile game application developed compared to baseline at week 6. The effect on the patient's Body Mass Index compared to baseline at week 6. The researcher will measure it. Body Mass Index is calculated by dividing the person's weight in kilograms by the square of the person's height in meters (kg/m²).

Full Information

First Posted
December 22, 2022
Last Updated
February 2, 2023
Sponsor
Sakarya University
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1. Study Identification

Unique Protocol Identification Number
NCT05725330
Brief Title
The Effect of Gamification on Patients With Type 2 Diabetes
Official Title
The Effect of Gamification on Disease Self-Management and Glycemic Control in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2023 (Anticipated)
Primary Completion Date
September 17, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sakarya 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
Diabetes is a broad-spectrum metabolic disorder that causes a defect in the organism's carbohydrate, fat, and protein metabolism processes due to insulin deficiency or impaired insulin effect. Diabetes requires continuous medical care and causes chronic, severe mortality and morbidity. More than 90% of all people with diabetes worldwide suffer from Type 2 DM. Diabetes self-management includes self-monitoring of blood glucose levels, knowing and managing the symptoms of hypoglycemia and hyperglycemia, adherence to diet, physical exercise, and diabetic foot care. Considering the high prevalent and undesirable consequences of diabetes in the world, it is necessary to benefit from new educational technologies and tools. One of these technologies is gamification, which increases the quality of education as an effective educational tool, creates motivation and enthusiasm, and develops a sense of competition in the target audience. This study plans to develop a game that will include virtual coaching to increase the self-management and glycemic control of patients with type 2 diabetes.
Detailed Description
The research will be carried out in two stages. In Stage 1, the game will be developed; The developed game's effectiveness will be evaluated in the 2nd stage by testing it. The game's content will include healthy nutrition, exercise, foot care, insulin use, and hypoglycemia management. When the games are completed, the virtual coach will step in, and the participants will be given motivational feedback. The game developed will be evaluated by the patients in the second stage with a two-week pilot period. It will be updated according to the feedback received. The final version of the game will be passed forward to the implementation phase. Individuals who are willing to participate in the study coming to Prof. Dr. Cemil Tascioglu City Hospital Diabetes Polyclinic will be randomly assigned to the intervention and control groups. A total of 88 patients (44 controls - 44 experiments) are planned to be recruited. In the first interview with the individuals in the intervention group, Within the scope of the pretest, the "Personal Information Form," "Anthropometric Measurement Form," "Metabolic Control Variables Form," and "Diabetes Self-Management Scale" will be used for evaluation. Outpatient appointment dates of the sixth week of the intervention program, "Anthropometric Measurement Form," "Metabolic Control Variables Form," and "Diabetes Self-Management Scale" forms will be used with patients for the final evaluation within the scope of the posttest. In the first meeting with the individuals in the control group, explanations about the research will be made. After their written consent is obtained at the first interview and within the scope of the pretest, the "Personal Information Form," "Anthropometric Measurement Form," "Metabolic Control Variables Form," and "Diabetes Self-Management Scale" will be used for evaluation. At the end of the sixth week of the study, when they come in for their outpatient clinic appointments, as a part of the posttest, "Anthropometric Measurement Form," "Metabolic Control Variables Form," and "Diabetes Self-Management Scale" forms will be used for the final evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gamification, Type 2 Diabetes, Self-management, Digital Health, Mobile Application

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Application of data collection forms for the initial evaluation. Teaching the use of mobile games, monitoring the use of mobile games in the experimental group by the researcher for six weeks, and applying data collection forms to the patients in the sixth week.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Application of data collection forms for the initial evaluation. Application of data collection forms to the patients in the sixth week. No intervention will be made to the patients in the control group other than the routine education given in the diabetes outpatient clinic.
Intervention Type
Other
Intervention Name(s)
Gamification and education with mobile game application
Intervention Description
This study aimed to provide self-care management by playing mobile games to patients with type 2 diabetes.
Primary Outcome Measure Information:
Title
self-management scale
Description
Determining whether or not the disease self-management scale scores in patients with Type 2 DM using the developed mobile game application increased at the end of the 6 weeks period. A minimum of 0 and a maximum of 10 points are obtained on the scale. If an item is skipped, it is evaluated as -3 points. Diabetes self-management increases as the score get closer to 10.
Time Frame
Change between the first day and the sixth week of the study
Secondary Outcome Measure Information:
Title
glycemic control (HbA1c)
Description
The effect that the mobile game application developed imposes on glycemic control in patients with Type 2 DM at six weeks compared to baseline. The effect of the patient's HbA1c tests on the 6th week compared to the baseline. Blood test (HbA1c) will be performed during the outpatient follow-up at the first and sixth weeks.
Time Frame
Change between day one and week 6 of the study
Title
anthropometric measurements (Body Mass Index)
Description
The effects on anthropometric measurements in patients with Type 2 DM using the mobile game application developed compared to baseline at week 6. The effect on the patient's Body Mass Index compared to baseline at week 6. The researcher will measure it. Body Mass Index is calculated by dividing the person's weight in kilograms by the square of the person's height in meters (kg/m²).
Time Frame
The change between the first day and the sixth week of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Two years or more with a diagnosis of Type 2 DM Patients using Insulin or Insulin and Oral Antidiabetic No sensory loss, such as vision and hearing loss, Having internet access and being able to use it, Ability to use a mobile phone with an Android or IOS (iPhone OS) operating system Patients who agreed to participate in the study Exclusion Criteria: Patients diagnosed with Type 1 DM and Gestational DM. Visual and auditory loss, Individuals without internet access Unable to communicate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pelin ILHAN, MSc
Phone
+905312711494
Email
pelinilhan.54@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Havva SERT, PhD
Phone
+905422512100
Email
hsert@sakarya.edu.tr
Facility Information:
Facility Name
Pelin ILHAN
City
Istanbul
State/Province
Sisli
ZIP/Postal Code
34360
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pelin ILHAN, MSc
Phone
+905312711494
Email
pelinilhan.54@hotmail.com
First Name & Middle Initial & Last Name & Degree
Havva SERT

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Gamification on Patients With Type 2 Diabetes

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