Technology and Family Thriving Study — Thrive  

Quality of Life Clinical Trial

Official title: Using Rendever to Improve the Quality of Life of Older Adults With Cognitive Impairments in Senior Living Communities and Their Family Members Who Live at a Distance

Status Completed

Clinical Trial Summary

The purpose of this project is to test the impact of different forms of technology (virtual reality vs. video chat) on quality of life and family relationships in older adults who reside in senior living communities and an adult child who lives at a distance. The study will also investigate whether responses to the technology and quality of life outcomes depend on older adults' level of cognitive impairment.

Clinical Trial Description

Purpose of the clinical trial: The virtual reality (VR) program, Rendever, enables older adults in senior living communities to maintain important family relationships, engage fully with life, and reconnect with their past, regardless of physical location, through its advanced networking and live-streaming capabilities. This project will test the immediate and longer-term impact of the Rendever virtual reality platform (vs. video chat) on the quality of life of residents and their adult children in an experimental design. The study will also investigate whether responses to the technology and quality of life outcomes depend on older adults' level of cognitive impairment.

Participants: Participants will be older adults (age 50+) with mild cognitive impairments (MCI) or mild to moderate Alzheimer's Disease or related dementias (AD/ADRD) who reside in senior living communities, and an adult child who lives at a distance. The resident-adult child dyads (N=192 dyads) will be recruited from 12 senior living communities in the greater Boston area and central California. Residents will participate from their senior living community and adult children will participate from their own home, at least 45 minutes driving distance away.

Study Design and Method: The design is a 2 (Intervention Group: Virtual Reality vs. Active Control) x 2 (Level of Cognitive Impairment: MCI vs. AD/ADRD) x Time (7 time points) design. Dyads will be randomly assigned to an intervention group (Virtual Reality vs. Video Chat Control). Dependent variables will include positive engagement while using the technology, quality of life, psychological and social well-being (loneliness, mental health, thriving, and relationship quality), and caregiver guilt (guilt, stress, and burden) assessed through surveys, interviews, and observational methods.

The experimental intervention will be implemented in a between-group design. Dyads will be randomly assigned to either the Virtual Reality Condition or the active Control Condition (video chat). Participants will complete a baseline survey (T1), followed by four activity sessions once a week for 4 consecutive weeks (T2-T5). Follow-up surveys will be conducted at 1-month (T6) and 3-months (T7) post-intervention. Residents and adult children will also be interviewed briefly after the intervention and at the each follow-up. All sessions will be video and audiotaped. Computerized and human coding will examine positive engagement and interpersonal dynamics while using the technology.

Dyads assigned to the virtual reality (VR) condition will engage in 4 weekly VR sessions that include immersive virtual adventures (e.g., bucket list travel) and reminiscence activities (e.g., virtual life story). Dyads assigned to the control condition will engage in 4 weekly video chat sessions. During these sessions, dyads will engage in conversations that are typical in their daily lives. All other procedures will be identical in the two conditions.

Sample size, recruitment, and statistical power: A power analysis using simulation methods (for multi-level regression models and structural equation models) was used to determine the sample size. A sample size of 192 dyads (96 in each intervention condition) evenly split between cognitive impairment groups (MCI vs. dementia) will achieve a high level of power for detecting the minimal expected effect size. Additional dyads will be recruited to account for attrition.

Statistical analysis: Because data from parent-adult child dyads will be dependent, and because the dyad is the unit of analysis for assignment to experimental conditions, the analysis of quantitative data will utilize linear models designed for nested (clustered) data. Hypothesis testing will be conducted with multi-level, random-effects regression and multi-level structural equation modeling.

Study Aims:

AIM 1: Determine whether virtual reality (vs. control) improves quality of life for residents and their adult children who live at a distance.

AIM 2: Determine whether the positive effects of virtual reality (vs. control) on quality of life depend upon residents' level of cognitive impairment (MCI vs. mild to moderate AD/ADRD).

AIM 3: Determine whether virtual reality (vs. control) reduces caregiver guilt for adult children and whether these effects depend on the adult child's own responses to the technology and their parent's responses to the technology. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Caregiver Burden
• Caregiver Burnout
• Dementia
• Family Relationship
• Loneliness
• Mental Health Wellness 1
• Quality of Life

• NCT number: NCT05150990
• Study type: Interventional
• Source: University of California, Santa Barbara
• Status: Completed
• Phase: N/A
• Start date: October 12, 2021
• Completion date: March 16, 2024