Going Down Memory Lane: A Technological Intervention

NCT04131374 | Unknown

• 1 other identifier: REB18-1902
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dementia

Keywords

Caregivers

Outcome Measures

Primary Outcomes (1)

• Change from baseline in participant's Behavioral or Psychological symptoms of dementia

  Caregivers will complete the Neuropsychiatric Inventory-Questionnaire (NPI-Q). This is a self-administered scale that is completed by the family caregiver. The scale has 12 items (dichotomous response) related to the behavioral or psychological symptoms of dementia. If the respondent indicates 'Yes,' a symptom is present, they are asked to rate the severity and distress. The severity of the symptoms is rated on a 3 point scale (mild, moderate, severe) over the last three months, and Distress is measured on a 5 point scale (no distress, minimal, mild, moderate, severe, very severe) indicating the amount of distress on the caregiver. The individual items are added together for an overall Severity and Distress score (minimum score 0- maximum score 96). Higher scores reflect worsening behavioural/psychological symptoms of dementia and increased caregiver distress.

  week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)

Secondary Outcomes (5)

• Change from baseline in participant's perception of person-centred care

  week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)

• Change from baseline in the participant's quality of life

  week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)

• Change from baseline in the caregiver's quality of life

  week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)

• Change from baseline in the caregiver's experience in caregiving

  week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)

• Change from baseline in the caregiver's experience of caregiver strain

  week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)

Study Arms (1)

Virtual Reality Intervention

EXPERIMENTAL

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.

Behavioral: Reminiscence Therapy

Interventions

Reminiscence Therapy BEHAVIORAL

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

Virtual Reality Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• The Brenda Strafford Foundation: collaborator

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Linda Duffett-Leger, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Duffett-Leger, PhD

CONTACT

+1(403) 220-4378; linda.duffettleger@ucalgary.ca

Gwen McGhan, PhD

CONTACT

+1(403) 220-2724; gwen.mcghan@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No Masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: June 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share