Clinical trial NCT04131374: Going Down Memory Lane: A Technological Intervention
Official title: Going Down Memory Lane: Developing a Technological Intervention for Older Adults Living With Dementia and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Keywords: Caregivers
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: The Brenda Strafford Foundation
First posted: 2019-10-18
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We will select 5 people living with dementia and their family caregiver. All participants will participate in developing their own tailored VR scenario and receive a weekly VR intervention (30 minutes) over a period of 10 weeks.

Participants (i.e. person living with dementia, family caregiver) will complete outcome measures at baseline (week 1), mid-intervention (week 5), the conclusion of intervention (week 10), and 5-weeks following the intervention (week 15).
Primary purpose: TREATMENT

Brief summary: Over 90% of people living with dementia (PLWD) experience behavioural and psychological symptoms of dementia, including apathy, depression, sleep disruptions, wandering, repetitive behaviours and anxiety. These symptoms can result in poor quality of life, burden for caregivers, and an increased risk for physical abuse of PLWD.

This study aims to evaluate the acceptability, feasibility, and efficacy of a reminiscence therapy intervention using virtual reality technology, to reduce symptoms associated with dementia in older adults. Further, the investigators will assess if the intervention improved the quality of life of participants and the relationship between the person living with dementia and their caregiver.

Detailed description: Background: Over 90% of people living with dementia (PLWD) experience behavioural and psychological symptoms of dementia (BPSD) including apathy, depression, sleep disruptions, wandering, repetitive behaviours and anxiety. BPSD can also result in poor quality of life, burden for caregivers, and an increased risk for physical abuse of PLWD. Incorporating the family caregiver into the plan of care may improve satisfaction and lower the burden associated with providing care for PLWD in a nursing home. New evidence suggests limited benefits of pharmacological interventions and increased risks for adverse events for PLWD. Results from systematic reviews suggest that Reminiscence Therapy (RT) has positive outcomes for people with dementia, such as elevated mood, improved cognition and enhanced behaviours. An additional systematic review indicates there are significant benefits of using information communication technology (ICT) for RT interventions. Virtual reality (VR) is emerging as a promising non-pharmacological approach for reducing symptoms of dementia and allows for tailoring of technological intervention to the user. To our knowledge, VR scenarios have never been developed as a RT intervention for PLWD and their caregiver.

Purpose and Objectives: The purpose of this innovative, interdisciplinary study is to design and test a VR technological intervention with older adults with dementia and their caregivers, guided by RT. The main research question is: Can a tailored VR intervention reduce BPSD among PLWD and improve the caregiving relationship? Study objectives are to: (1) interview caregiving dyads to collect historical data to create tailored VR interventions using iterative design process; (2) test VR intervention with the caregiving dyads to assess: (a) impact on BPSD among PLWD and quality of the relationship between the PLWD and their family caregiver; and (b) impact of the intervention on family caregiver outcomes.

Study Design: The proposed feasibility (repeated measure design) study will be conducted in two phases and will include qualitative and quantitative data collection.

In PHASE 1 (design), 5 PLWD and their family caregiver will participate in 2-3 interviews which will be used to generate their personalized VR scenarios.

In PHASE 2 (testing), the tailored VR sessions from phase 1, will be used as a weekly intervention with each caregiving dyad over 10 weeks. Each tailored session will be 30 minutes in length. Participants will be positioned beside each other in stabilizing chairs, both wearing the 3D glasses, and viewing the same scenario.

Participants will be evaluated at 4-time points \[week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5-week follow up)\]. Using previously validated measures, participants living with dementia will be assessed on:

1. Behavioural or psychological symptom of dementia (Neuropsychiatric Inventory- Questionnaire)
2. Perceptions of person-centred care (Person-centered Climate Questionnaire-patient version)
3. Quality of Life (World Health Organization Quality of Life Instrument)

Family Caregiving participants will be assessed on:

1. Caregiving experience (A. Caregiver Reaction Scale, and B. Modified Caregiver Strain Index)
2. Quality of Life (World Health Organization Quality of Life Instrument)

Eligibility criteria: Inclusion Criteria:

* diagnosed with moderate stages (stages 1-3) of dementia
* able to speak and read English
* caregivers should be a family caregiver of the person living with dementia
* caregivers should be 18 years of age or older
* caregivers should be able to speak and read English

Exclusion Criteria:

* physical limitations that prevent the application of research instruments (i.e. Virtual Reality technology)
* caregivers that do no reside in the same city as the person living with dementia, which prevents them from attending the weekly sessions.

Primary outcomes:
measure: Change from baseline in participant's Behavioral or Psychological symptoms of dementia
timeFrame: week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)
Secondary outcomes:
measure: Change from baseline in participant's perception of person-centred care
timeFrame: week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)
measure: Change from baseline in the participant's quality of life
timeFrame: week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)
measure: Change from baseline in the caregiver's quality of life
timeFrame: week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)
measure: Change from baseline in the caregiver's experience in caregiving
timeFrame: week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)
measure: Change from baseline in the caregiver's experience of caregiver strain
timeFrame: week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Linda Duffett-Leger, PhD
role: PRINCIPAL_INVESTIGATOR
References: