SugarVita: a Digital Board Game

NCT06392178 | Recruiting

• 1 other identifier: N24.020.
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The serious digital game, SugarVita, is a collaborative effort between the Máxima Medical Centre (MMC) and Eindhoven University of Technology (TUe), intending to enhance self-management for individuals with diabetes. As a mobile application available on smartphones and tablets, SugarVita emerged from cooperative design sessions involving patients diagnosed with diabetes. The average age of type 2 diabetes patients in the Netherlands exceeds 50 years. Following extensive discussions with these patients, the decision was made to model SugarVita after a digital board game, reminiscent of the classic board game 'ganzenbord' (Game of the Goose). In SugarVita, players experience a day in the life of an individual with diabetes, making choices regarding dietary habits, physical activity, and medication intake. Throughout this simulated day, the blood glucose level serves as a central theme. Players earn points by effectively managing their blood glucose levels. SugarVita can be played together with relatives or friends. The game aims to give people with diabetes more control over their chronic condition. Self-care is now seen as the primary approach to diabetes, which is a complex multi-faceted task where training and education are crucial. Importantly, SugarVita recognizes that a conventional 'dry' explanation may not resonate with everyone.

Conditions

Diabetes Mellitus, Type 2

Keywords

gamification; mHealth; self-management; diabetes type 2

Outcome Measures

Primary Outcomes (3)

• To assess the impact of SugarVita on self-management

  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

  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

  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 Outcomes (3)

• To evaluate the patients perception on SugarVita and the usage of using digital games as an educational tool

  8 weeks

• To gather data from player performances in SugarVita (how long do participants play SugarVita in minutes)

  8 weeks

• To gather data from player performances in SugarVita (how many times do they log into the game, frequency will be measured)

  8 weeks

Study Arms (2)

SugarVita

EXPERIMENTAL

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

Device: SugarVita

Standard care

NO INTERVENTION

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

Interventions

SugarVita DEVICE

Serious digital game (application) that can be played on mobile phone, tablet or personal computer. Self-developed game.

SugarVita

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or breastfeeding women
• Malignancy except basal and squamous cell skin cancer

Sponsors & Collaborators

• Maxima Medical Center: lead

Study Sites (1)

Maxima Medical Centre

Eindhoven, North Brabant, 5631 BM, Netherlands

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Edouard Reinders, MD

CONTACT

0031408886300; edouard.reinders@mmc.nl

Pleun Wouters, PhD

CONTACT

0031408886300; Pleun.van.poppel@mmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 30, 2024
• Study Start: April 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

NL (1)