Going Down Memory Lane: A Technological Intervention

NCT ID: NCT04131374

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-12-31

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)

Conditions

Dementia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality Intervention

Virtual Reality Intervention: Each Person Living with Dementia-caregiver dyad will receive 10 weekly sessions of tailored reminiscence therapy delivered via virtual reality. Each session will last for a period of 15-30 minutes.

Group Type: EXPERIMENTAL

Reminiscence Therapy

Intervention Type: BEHAVIORAL

Virtual reality scenarios will be used to delivered reminiscence therapy with each caregiving dyad (i.e. person living with dementia; family member).

Interventions

Reminiscence Therapy

Virtual reality scenarios will be used to delivered reminiscence therapy with each caregiving dyad (i.e. person living with dementia; family member).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Brenda Strafford Foundation

UNKNOWN

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda Duffett-Leger, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Central Contacts

Linda Duffett-Leger, PhD

Role: CONTACT

linda.duffettleger@ucalgary.ca

+1(403) 220-4378

Gwen McGhan, PhD

Role: CONTACT

gwen.mcghan@ucalgary.ca

+1(403) 220-2724

Other Identifiers

REB18-1902

Identifier Type: -

Identifier Source: org_study_id