Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05725330
Status:
RECRUITING
Last Update Posted:
2023-02-13
First Post:
2022-12-22
Brief Title:
The Effect of Gamification on Patients With Type 2 Diabetes
Sponsor:
Sakarya University
Organization:
Sakarya University
Study Overview
Official Title:
The Effect of Gamification on Disease Self-Management and Glycemic Control in Patients With Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetes is a broad-spectrum metabolic disorder that causes a defect in the organisms 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 games effectiveness will be evaluated in the 2nd stage by testing it The games 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None