- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06392178
SugarVita: a Digital Board Game
SugarVita: an Educative Digital Board Game for Self-management in Diabetes
Study Overview
Detailed Description
The majority of diabetes mellitus patients in the Netherlands are aged 50 and above, predominantly diagnosed with type 2 diabetes mellitus. Patient education in this context primarily occurs through consultations with healthcare professionals such as general practitioners, internists, and diabetes nurses. However, these interactions alone may not comprehensively address the complexities associated with managing a chronic condition like diabetes. Consequently, self-education constitutes a crucial role in empowering patients to cope with their disease. In response to this need, the investigators have developed SugarVita, a serious game designed to facilitate patient training and skill development in diabetes regulation within the comfort of their homes through playful learning.
Previous studies have indicated that serious diabetes games can enhance patient self-management, potentially leading to controlled or reduced healthcare costs, although the impact on HbA1c levels is often modest. SugarVita distinguishes itself by visualizing the short-term effects of a player's decisions on their glycemic levels and providing rewards for healthy and appropriate choices. The ultimate goal is to encourage the cultivation of health-promoting behaviors in daily life.
SugarVita adopts the format of a digital board game, akin to the Game of the Goose, where players progress through the board by rolling a dice. The SugarVita board comprises a circular arrangement of tiles, mirroring a full day (24 hours), with each tile representing a 20-minute interval. Players traverse the day, encountering various events such as meals, activities, and emotional experiences, all presented in a digital gaming format. The board features distinct pathways corresponding to workdays, outdoor days, and leisure days. Players enter the game through a personalized setup facilitated by the simulator. The primary objective for players is to maintain their glucose levels within a safe range, and therefore earn points by doing so. While immersed in the game, players assume the perspective of an individual with diabetes, navigating the daily decisions inherent to the condition. In this interactive experience, players make choices regarding their food intake, engage in physical activities, and manage medication usage, including insulin doses. The repercussions of these decisions are reflected in the game through a visible glucose meter, dynamically responding to the player's actions. Points are awarded when the glucose meter remains within the target range, creating a learning environment through gameplay and direct feedback. The player achieving the highest score emerges as the winner.
The multiplayer aspect of SugarVita allows patients with diabetes to engage in the game alongside their relatives, fostering discussions about the diverse choices made during gameplay. This collaborative approach enhances mutual understanding of a relative's condition, providing additional support. The unique multiplayer feature of SugarVita distinguishes it from other diabetes games. Involving the social network of patients can potentially contribute to the development of healthier habits.
Designed for the largest segment of diabetes patients, namely young seniors aged 50 to 75 with type 2 diabetes, SugarVita targets lifestyle and habit changes crucial for disease management. Our clinical experience underscores the challenges these patients face in altering their habits and understanding the intricacies of glucose level regulation. Within the young senior demographic, considerable variations exist, including differences in educational attainment and attitudes towards personal health. Some individuals may be illiterate and display minimal concern for their health, while others are motivated to initiate positive changes. Recognizing these differences, the investigators adopted varied approaches to appeal to distinct patient types. Target group interviews further revealed that our audience enjoys board games, expresses openness to digital games, and prefers playing on tablets or mobile phones. While our primary focus is on young senior type 2 patients, SugarVita aims to be appealing to a broader audience, including other diabetes patients, their relatives, and caregivers.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Edouard Reinders, MD
- Phone Number: 0031408886300
- Email: edouard.reinders@mmc.nl
Study Contact Backup
- Name: Pleun Wouters, PhD
- Phone Number: 0031408886300
- Email: Pleun.van.poppel@mmc.nl
Study Locations
-
-
Noord Brabant
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Eindhoven, Noord Brabant, Netherlands, 5631 BM
- Recruiting
- Maxima Medical Centre
-
Contact:
- Edouard Reinders, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Informed consent obtained before trial related activities
- Diagnosed with T2DM
- HbA1c levels > 64 mmol/mol (before start of study)
- BMI > 25 kg/m2
- Age above 18 years
- Patient's language skills are sufficient for participation
- Subject has a smartphone or tablet and is willing to install the needed application on it
Exclusion Criteria:
- Pregnancy or breastfeeding women
- Malignancy except basal and squamous cell skin cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SugarVita
Participants in the intervention group will download and play the app SugarVita on their mobile phone or tablet, or they can borrow a tablet from the research group.
All participants are requested to fill in questionnaires concerning diabetes related topics at the start of the study, and after 8 weeks
|
Serious digital game (application) that can be played on mobile phone, tablet or personal computer.
Self-developed game.
|
No Intervention: Standard care
Participants in the control group will receive standard care, the usual care that is being given at the outpatient clinic.
All participants are requested to fill in questionnaires concerning diabetes related topics at the start of the study, and after 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the impact of SugarVita on self-management
Time Frame: 8 weeks
|
This will be measured by filling in the Diabetes Management Self-Efficacy Scale (DSMES) at the beginning of the study (week 1) and at the end (week 8).
This is a dutch validated questionnaire consisting of 20 questions.
A higher score indicates a higher estimated level of self-management.
|
8 weeks
|
To assess the impact of SugarVita on self-confidence
Time Frame: 8 weeks
|
This will be measured by filling in the 'Confidence in Diabetes Self-car Scale' questionnaire at the beginning of the study (week 1) and at the end (week 8).
This is a dutch validated questionnaire consisting of 20 questions.
A higher score indicates a higher estimated level of self-confidence.
|
8 weeks
|
To assess the impact of SugarVita on diabetes related knowledge
Time Frame: 8 weeks
|
This will be measured by filling in a self created dutch questionnaire concerning questions about diabetes knowledge.
This questionnaire will be filled in at the beginning of the study (week 1) and at the end (week 8).
This self-developed questionnaire consisting of 19 questions.
A higher score indicates a higher estimated level of diabetes related knowledge.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the patients perception on SugarVita and the usage of using digital games as an educational tool
Time Frame: 8 weeks
|
This will be assed by a self-made questionnaire concerning 11 questions.
Participants in the SugarVita group will fill in this questionnaire at the end of the study.
Participants in the regular care group do not fill in this questionnaire.
|
8 weeks
|
To gather data from player performances in SugarVita (how long do participants play SugarVita in minutes)
Time Frame: 8 weeks
|
This data will be collected automatically if participants log into their SugarVita account
|
8 weeks
|
To gather data from player performances in SugarVita (how many times do they log into the game, frequency will be measured)
Time Frame: 8 weeks
|
This data will be collected automatically if participants log into their SugarVita account
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N24.020.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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