DementiaNCT04131374
Going Down Memory Lane: A Technological Intervention
A study testing Reminiscence Therapy in people with Dementia, run by University of Calgary.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Reminiscence Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Going Down Memory Lane: Developing a Technological Intervention for Older Adults Living With Dementia and Their Family Caregivers
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.
Read the 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:
- Behavioural or psychological symptom of dementia (Neuropsychiatric Inventory- Questionnaire)
- Perceptions of person-centred care (Person-centered Climate Questionnaire-patient version)
- Quality of Life (World Health Organization Quality of Life Instrument)
Family Caregiving participants will be assessed on:
- Caregiving experience (A. Caregiver Reaction Scale, and B. Modified Caregiver Strain Index)
- Quality of Life (World Health Organization Quality of Life Instrument)
- Conditions
- Dementia
- Being tested
- Reminiscence Therapy
- Keywords
- Caregivers
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminiscence TherapyBehavioural
Virtual reality scenarios will be used to delivered reminiscence therapy with each caregiving dyad (i.e. person living with dementia; family member).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Reminiscence Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Participants living with dementia will complete the Person-Centered Climate Questionnaire (patient version). The Person-Centered Climate Questionnaire (patient version) measures the extent to which the psychosocial environment of a setting is perceived as being person-centred. The tool has 17 items in which respondents are asked to agree or disagree by selecting an answer on a 6 point scale, from "No, I disagree completely" to "Yes, I agree completely." The items are added together for an overall score, with a minimum scale score of 0 and a maximum scale score of 85. Higher scores reflect a more person-centred environment.
Measured: 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
Participants living with dementia will complete the World Health Organization Quality of Life Instrument (Brief). The World Health Organization Quality of Life Brief Instrument measures the quality of life through the following four domains and two overall health and quality of life items: physical health, psychological, social relationships, and environment. The four domain scores are scaled in a positive direction with higher scores indicating a higher quality of life. There are three items that are reversed scored. The possible raw score ranges for each domain are as follows: Physical Health =28, Psychological =24, Social Relationships =12, and environment =32.
Measured: 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
Caregivers will complete the World Health Organization Quality of Life Instrument (Brief). The World Health Organization Quality of Life Brief Instrument measures the quality of life through the following four domains and two overall health and quality of life items: physical health, psychological, social relationships, and environment. The four domain scores are scaled in a positive direction with higher scores indicating a higher quality of life. There are three items that are reversed scored. The possible raw score ranges for each domain are as follows: Physical Health =28, Psychological =24, Social Relationships =12, and environment =32.
Measured: 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
Caregivers will complete the Caregiver Reaction Scale. The Caregiver Reaction Scale is a brief self-report measure, containing 8 subscales related to multiple dimensions of caregiving: caregiver's role captivity, overload, relational deprivation, caregiving competence, personal gain, family beliefs and actions and employment. The scale has a total of 54 items, which are scored on a 4-point scale where 1=not at all and 4 = completely. Scores for each subscale are averaged, with higher mean scores indicated high levels of negative and positive experiences. Subscales scores are interpreted independently.
Measured: 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
Caregivers will complete the Modified Caregiver Strain Index. The tool has 13 items that measure strain related to care provision, and it measures the following domains: financial, physical, psychological, social, and personal. Each item is scored on a 3 point scale (yes [2 points], sometimes [1 point], no [0 points'). Scores range from 0 to 26, and a higher score indicated a higher level of caregiver strain.
Measured: week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Jun 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- The Brenda Strafford Foundation
- Responsible party
- Sponsor
- Investigators
- Linda Duffett-Leger, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131374
- Sponsor's protocol ID
- REB18-1902
- Status last verified
- May 2022
- First submitted
- 16 Oct 2019
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Going Down Memory Lane: Developing a Technological Intervention for Older Adults Living With Dementia and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT04131374
- Acronym / sponsor ID
- REB18-1902
- Conditions
- Dementia
- Keywords
- Caregivers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- The Brenda Strafford Foundation
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Behavioural or psychological symptom of dementia (Neuropsychiatric Inventory- Questionnaire)
- Perceptions of person-centred care (Person-centered Climate Questionnaire-patient version)
- Quality of Life (World Health Organization Quality of Life Instrument)
Family Caregiving participants will be assessed on:
- Caregiving experience (A. Caregiver Reaction Scale, and B. Modified Caregiver Strain Index)
- Quality of Life (World Health Organization Quality of Life Instrument)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Intervention | Experimental | Behavioral: Reminiscence TherapyVirtual 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reminiscence TherapyVirtual reality scenarios will be used to delivered reminiscence therapy with each caregiving dyad (i.e. person living with dementia; family member). | Behavioural | Virtual Reality Intervention |
Primary outcome
Change from baseline in participant's Behavioral or Psychological symptoms of dementia
Time frame: week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)
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.
5 secondary outcomes
Change from baseline in participant's perception of person-centred care
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Duffett-Leger, PhD principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing Reminiscence Therapy in people with Dementia, run by University of Calgary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Duffett-Leger, PhD (+1(403) 220-4378, linda.duffettleger@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in participant's Behavioral or Psychological symptoms of dementia (time frame: week 1 (baseline), week 5 (mid-intervention), week 10 (conclusion of intervention) and week 15 (5 week follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.