GamificationNCT05725330
The Effect of Gamification on Patients With Type 2 Diabetes
A study testing Gamification and education with mobile game application in people with Gamification and Type 2 Diabetes, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gamification, Type 2 Diabetes, Self-management
- What is being tested?
- Gamification and education with mobile game application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients diagnosed with Type 1 DM and Gestational DM.
- Visual and auditory loss,
- Individuals without internet access
- Unable to communicate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pelin ILHAN
Istanbul, Sisli, 34360
Pelin ILHAN, MSc, +905312711494, pelinilhan.54@hotmail.com
Havva SERT
About this study
Official title: The Effect of Gamification on Disease Self-Management and Glycemic Control in Patients With Type 2 Diabetes
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.
Read the 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.
- Being tested
- Gamification and education with mobile game application
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamification and education with mobile game applicationOther
This study aimed to provide self-care management by playing mobile games to patients with type 2 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Gamification and education with mobile game application |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between the first day and the sixth week of the study
Secondary outcomes (2)
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.
Measured: Change between day one and week 6 of the study
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).
Measured: The change between the first day and the sixth week of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start25 Feb 2023 (estimated)
- Primary completion17 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GamificationStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725330
- Sponsor's protocol ID
- SakaryaU.
- Status last verified
- Feb 2023
- First submitted
- 22 Dec 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gamification on Disease Self-Management and Glycemic Control in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05725330
- Acronym / sponsor ID
- SakaryaU.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 25 Feb 2023 (estimated)
- Primary completion
- 17 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Gamification and education with mobile game applicationApplication 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Patients diagnosed with Type 1 DM and Gestational DM.
- Visual and auditory loss,
- Individuals without internet access
- Unable to communicate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamification and education with mobile game applicationThis study aimed to provide self-care management by playing mobile games to patients with type 2 diabetes. | Other | Intervention Group |
Primary outcome
self-management scale
Time frame: Change between the first day and the sixth week of the study
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.
2 secondary outcomes
glycemic control (HbA1c)
Time frame: Change between day one and week 6 of the study
anthropometric measurements (Body Mass Index)
Time frame: The change between the first day and the sixth week of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamification and education with mobile game application in people with Gamification and Type 2 Diabetes, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pelin ILHAN, MSc (+905312711494, pelinilhan.54@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-management scale (time frame: Change between the first day and the sixth week of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.