The Effect of Gamification on Patients With Type 2 Diabetes

NCT ID: NCT05725330

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-25
• Study Completion Date: 2023-12-30

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.

Conditions

Gamification; Type 2 Diabetes; Self-management; Digital Health; Mobile Application

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Gamification and education with mobile game application

Intervention Type: OTHER

This study aimed to provide self-care management by playing mobile games to patients with type 2 diabetes.

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gamification and education with mobile game application

This study aimed to provide self-care management by playing mobile games to patients with type 2 diabetes.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pelin ILHAN

Istanbul, Sisli, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Pelin ILHAN, MSc

Role: CONTACT

pelinilhan.54@hotmail.com

+905312711494

Havva SERT, PhD

Role: CONTACT

hsert@sakarya.edu.tr

+905422512100

Facility Contacts

Pelin ILHAN, MSc

Role: primary

pelinilhan.54@hotmail.com

+905312711494

Havva SERT

Role: backup

Other Identifiers

SakaryaU.

Identifier Type: -

Identifier Source: org_study_id