- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07460778
Development of Serious Games for Rehabilitation: a Delphi Study
Development of Serious Games for Rehabilitation, a Delphi Study
Study Overview
Status
Intervention / Treatment
Detailed Description
This study will consist of different phases:
Phase 1:
The first phase consists of an online survey aimed at identifying important tools and methods for each stage of development, as well as across all stages of development. Furthermore, the survey will try to identify key principles that should be taken into account across the entire developmental process of serious games for rehabilitation.
Phase 2:
The second phase consists of online focus groups that will be organized to discuss the results of the online survey and add missing data if needed. These discussions will be held using Microsoft Teams. During these discussions a general model will be discussed en a revision of the results from the previous phase will be done. The results from this discussion will be used to structure the next phase.
Phase 3:
The third and final phase consists of consecutive online surveys in which you will be asked to rank the different items that were mentioned in the previous phase. These results will be collected and analyzed. After which you will get the chance to revise your answer based on all the results. This will be repeated until consensus is reached.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ruben Debeuf
- Phone Number: 0032 478821658
- Email: ruben.debeuf@vub.be
Study Contact Backup
- Name: Eva Swinnen
- Email: eva.swinnen@vub.be
Study Locations
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-
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Brussels, Belgium, 1090
- Recruiting
- Vrije Universiteit Brussel
-
Contact:
- Ruben Debeuf
- Phone Number: 0032 478821658
- Email: ruben.debeuf@vub.be
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Experience with (the development of) serious games for rehabilitation
Exclusion Criteria:
- No experience with (the development of) serious games for rehabilitation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Phase 1
The first phase consists of an online survey aimed at identifying important tools and methodologies for each stage of development, as well as across all stages of development.
To structure this survey the TRL model will be used as a conceptual framework (appendix 1).
The different levels of the model will be used as stages of development to base the questions on.
However, the aim is not to strictly adhere to this model, but to gather input on what methods should be used and what can be adjusted from existing models such as the TRL model to maximize adoption of serious games into care.
Furthermore, the survey will try to identify key principles that should be taken into account across the entire developmental process of serious games for rehabilitation.
These key principles, such as a user-centered approach, working evidence-based, maximizing engagement of end-users, etc., are the foundation for the developmental process and should be adhered to throughout the entire process.
|
The first phase will consist of an online survey questionnaire aimed at identifying key development methods and tools for each stage of development.
The survey will be structured using the Technology Readiness Level model and, by using open questions, experts will be asked to give their input on this model and the important items for each stage of development.
Furthermore, the experts will be asked to identify the key principles that they find detrimental to the development of serious games for rehabilitation across all stages of development.
Data collection for the first phase is completed after at least 30 participants answered the online survey.
After all data is collected, the results from this online survey will be thematically analyzed and used to structure the focus group discussions organized in phase two.
|
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Other: Phase 2
The second phase consists of focus groups that will be organized to discuss the results of the online survey and add missing data if needed.
The focus group discussions will also be structured based on the TRL model used during the survey and will expand on the results mentioned by the experts (appendix 2 and 3).
After all focus group discussion are completed the results will be anonymized, aggregated and reported to the experts.
This will provide them with the opportunity to further revise their answers based on all the results.
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The second phase of the modified Delphi study will consist of online focus group discussions (using Microsoft Teams) with 6 to 12 experts per session.
First, a summary will be given of the results from the survey phase.
Following this, the experts will be asked to revise and add onto these results for each stage of development.
Additionally the experts will be asked to revise the key principles that span across all stages of development and add missing key principles.
Lastly they will be asked to identify already existing methodologies or frameworks that incorporate some (or all) of the mentioned tools or methods.
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|
Other: Phase 3
The third and final phase consists of consecutive online surveys in which the experts are asked to rank the different items that were mentioned in the previous phases based on priority.
Similar to the focus group discussions, the answers from these phases will be anonymized, aggregated and reported to the experts after each ranking phase.
Experts will have the opportunity to revise their answers across multiple rounds.
This ranking process is repeated until consensus is reached for all items.
Consensus will be defined using the Kendall's W coefficient of concordance.
Kendall's W is a value between 0 and 1 assessing agreement, with a W value of 0.5 indicating moderate agreement and 0.7 indicating strong agreement.
A cut-off of 0.5 will be used to determine consensus.
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In the next phase, experts will be asked to rank the different items mentioned during the focus group discussions through an online survey using Microsoft Forms.
For each stage of development, the relevant items will be presented, and the experts will have to rank these items based on their relative priority for the development of serious games for rehabilitation.
The results from this phase will be anonymized and sent to the experts as feedback.
Afterwards the experts will have the chance to revise their answers based on this feedback.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Information on the development process of serious games for rehabilitation
Time Frame: Through study completion, on average 1 year
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Throughout the Delphi study, qualitative data will be collected (online surveys, focus group discussions, etc.) from experts in the field of serious games for rehabilitation on what methods and/or tools shoudl be used in the development process of serious games for rehabilitation.
This data will be collected for all different stages of the development process.
Furthermore, overarching key principles that span across all stages of development will also be identified based on expert opinion.
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Through study completion, on average 1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eva Swinnen, Vrije Universiteit Brussel
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
Other Study ID Numbers
- Delphi serious games
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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