Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568211
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
A Virtual Reality At Home Intervention for People Living with Dementia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
VRxHome a Virtual Reality At-Home Intervention for Persons Living with Dementia and Their Care Partners
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VRxHome
Brief Summary:
The goal of the current study is to design and evaluate a virtual reality VR at-home intervention to facilitate communication between persons living with dementia PLwD and their familyfriend care partners and in turn improve their interpersonal relationships and quality of life The project also aims to provide a direct comparison of an immersive VR system with non-immersive tablet-based technology
PLwD and care partner interactions will be recorded during each of the following sessions and then used for the primary measure of verbal and non-verbal communication
Picture Book condition baseline PLwD and care partner view pictures together on photo album
VR condition PLwD watch 360 degree videos on a VR and the care partner watches the same content concurrently on a paired tablet
Table-Only condition PLwD and care partner watch 360 videos together on the tablet
PLwD and care partner interactions will be recorded during each of the following sessions and then used for the primary measure of verbal and non-verbal communication
Picture Book condition baseline PLwD and care partner view pictures together on photo album
VR condition PLwD watch 360 degree videos on a VR and the care partner watches the same content concurrently on a paired tablet
Table-Only condition PLwD and care partner watch 360 videos together on the tablet
Detailed Description:
Head Mounted VR headsets allow a person to transport to alternate realities such as visiting another country attending a concert or a sporting event The evidence to date suggests that VR experiences have positive impact on the well-being of individuals living with dementia Most of this work however has been in more formal settings whether its long-term care or community programs with trained formal care partners or researchers Further little work has explored specifically communication outcomes within the family dynamics
After obtaining informed consent participants will complete a Demographic and Health History questionnaire and then will be scheduled for their first home visit During this session researcher will provide training on how to use the devices how to video-record the study sessions and how to complete study questionnaires through the supplied laptop The PLwD and care partner will also view a picture book together while their interaction is being recorded through a video-conferencing software
Participants will then begin the four weeks of intervention where they will either be placed in the VR first intervention condition for the first two week or the Tablet-only first intervention condition weeks 1 and 2 and then they will switch and receive the other device in the following two weeks weeks 3 and 4 Participants will receive additional at-home training in-between two intervention phases Irrespective of the condition once a week participants will have a session with researcher over a video-conferencing software where they watch a 20 mins video sequence that has a combination of 4 videos of different themes animal entertainment travel and sports preselected for them This is then followed by a short semi-structured interview asking participants about their preferences and experience In addition participants are asked to try the devices on their own and record their interactions
In addition to the video recording of sessions which will be used for analyses of verbal and non-verbal communication and interview data participants will be asked to complete a set of questionnaires at baseline and after each phase of the intervention They will also be given a journal to note down any additional information they would like to share beyond those captures in interviews and questionnaires
After completing the study a final semi-structure interview will be conducted with participants to evaluate the overall feasibility and effectiveness of intervention Study will complete with a final home visit to pick up devices
After obtaining informed consent participants will complete a Demographic and Health History questionnaire and then will be scheduled for their first home visit During this session researcher will provide training on how to use the devices how to video-record the study sessions and how to complete study questionnaires through the supplied laptop The PLwD and care partner will also view a picture book together while their interaction is being recorded through a video-conferencing software
Participants will then begin the four weeks of intervention where they will either be placed in the VR first intervention condition for the first two week or the Tablet-only first intervention condition weeks 1 and 2 and then they will switch and receive the other device in the following two weeks weeks 3 and 4 Participants will receive additional at-home training in-between two intervention phases Irrespective of the condition once a week participants will have a session with researcher over a video-conferencing software where they watch a 20 mins video sequence that has a combination of 4 videos of different themes animal entertainment travel and sports preselected for them This is then followed by a short semi-structured interview asking participants about their preferences and experience In addition participants are asked to try the devices on their own and record their interactions
In addition to the video recording of sessions which will be used for analyses of verbal and non-verbal communication and interview data participants will be asked to complete a set of questionnaires at baseline and after each phase of the intervention They will also be given a journal to note down any additional information they would like to share beyond those captures in interviews and questionnaires
After completing the study a final semi-structure interview will be conducted with participants to evaluate the overall feasibility and effectiveness of intervention Study will complete with a final home visit to pick up devices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None