A Virtual Reality At Home Intervention for People Living with Dementia
NCT Number: NCT06568211
Acronym: VRx@Home
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dementia
Sponsor: University Health Network, Toronto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-11-17
Completion Date: 2024-12

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 family/friend 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

Primary Outcome Measures: Quality of conversation and dyadic interactions (observations), Trained research assistants will code the video recordings for the quality of participation, support, and engagement using the standardized Measure of Participation in Conversation for Dementia (focused on PLwD) and Measure of Support in Conversation for Dementia (focused on Care partner)., Measures will be collected from baseline until the end of the intervention (week 4).|Quality of conversation and dyadic interactions (self-report), Participating families will complete a communication questionnaire., Measures will be collected from baseline until the end of the intervention (week 4).|Verbal Communication, Trained research assistants will code the video recordings for measures of verbal communication (e.g., utterance length, coherence, reminiscence). This data will be analyzed through both qualitative and quantitative methods., Measures will be collected from baseline through the end of intervention (week 4)|Nonverbal Communication, Trained research assistants will code the video recordings for measures of nonverbal communication (e.g., gestures, familial expressions). This data will be analyzed through both qualitative and quantitative methods., Measures will be collected from baseline through the end of intervention (week 4)
Secondary Outcome Measures: Quality of Life, The Quality of Life in Alzheimer's Dementia (QoL-AD) will be administered to participants with dementia and caregiver-participants to evaluate subjective quality of life. The QoL-AD is a 13-item questionnaire employing 4-point Likert scales. Higher scores indicate greater subjective quality of life., Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)|Well-Being, The WHO (Five) Well-Being Index will be administered to participants living with dementia and caregiver-participants to evaluate subjective wellbeing. The WHO (Five) is a 5-item questionnaire employing 6-point Likert scales., Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)|Caregiver Burden, The Short Zarit Burden Interview tool will be completed by caregiver-participants and will be used to evaluate subjective feelings of caregiver burden associated with being a caregiver for the person with dementia. The Short Zarit Burden Interview is a 6-item questionnaire that employs a 5-point Likert scale., Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)|Usability/Preference, System Usability Scale (SUS) will be administered to evaluate device usability/ease-of-use for both VR and Tablet-only conditions. The SUS is a 10-item questionnaire employing 5-point Likert scales., Measure will be collected after each phase of the intervention (end of week 2 and week 4)