Virtual Reality and Technologies for Elderly

• Sponsor: TOPMED (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06076148
• Collaborator: Conseil de recherches en sciences naturelles et en génie du Canada (Other), SEC Fonds Immobilier Groupe Maurice (Other), Fédération Québécoise des Loisirs en Institution (Other), Fédération de l'Age D'Or du Québec (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief Summary

The objective of this clinical trial is to understand the determinants and opportunities for acceptance of immersive technologies to support physical, cognitive, and social health and the possibilities for "aging well" among the new generation of older adults. The main questions it aims to answer are:

• What are the needs and expectations in terms of immersive activities and intervention methods according to age?

• Do different game modes influence the needs and expectations in immersive activities of this population? 50 participants will be asked to complete a preliminary questionnaire about their activity habits and preferences. They will then be invited to participate in individual or multiplayer virtual reality game trials, a post-trial discussion about their experience and a questionnaire completion.

Condition or Disease	Intervention/Treatment	Phase
Aging Well	Device: Virtual reality games	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: All participants will test both multiplayer and individual games. Order of testing is reversed in between arms.All participants will test both multiplayer and individual games. Order of testing is reversed in between arms.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Aging Well by Being Connected - Phase 1
• Actual Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Individual then multiplayer games Participants of this group will conduct the sessions in the following order : Focus group about individual virtual reality games then Focus group about multiplayer virtual reality games.	Device: Virtual reality games; three individual games (physical, cognitive and relaxation) and two multiplayer games will be tested.
Experimental: Multiplayer then individual games Participants of this group will conduct the sessions in the following order : Focus group about multiplayer virtual reality games then Focus group about individual virtual reality games.	Device: Virtual reality games; three individual games (physical, cognitive and relaxation) and two multiplayer games will be tested.

Outcome Measures

Primary Outcome Measures

1. Perception of immersive technologies experience [Immediately after the intervention]

   Satisfaction with the trials, challenges encountered measured with 4 open questions during the focus group

2. Integration of virtual reality [Immediately after the intervention]

   Integration factors in daily life, usefulness for the intergenerational link, barriers to integration with 3 open questions during the focus group.

3. Acceptability of immersive technologies [Immediately after the intervention]

   Intention to use with one open question during the focus group.

Secondary Outcome Measures

1. Change in interest in immersive activities [Baseline and immediately after the intervention]

   Total score for 13 questions with 3 point scale (low, medium, high respectively scored 1,2,3)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Be 50 years old or older

Exclusion Criteria:

• Having functional limitations

• Having cognitive impairments

• Being at risk of epilepsy

• Not being autonomus

• Having a pacemaker

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TOPMED	Quebec		Canada	G1S1C1

Sponsors and Collaborators

• TOPMED
• Conseil de recherches en sciences naturelles et en génie du Canada
• SEC Fonds Immobilier Groupe Maurice
• Fédération Québécoise des Loisirs en Institution
• Fédération de l'Age D'Or du Québec

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TOPMED
• ClinicalTrials.gov Identifier: NCT06076148
• Other Study ID Numbers: RD-407_VR 50+
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by TOPMED: Aging well; Virtual reality; Immersive technology; Older adults; Physical activity; Cognitive activity; Social behaviour

Study Results

No Results Posted as of Oct 10, 2023