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Palliative CareNCT04030910

'LIFEView' Audiovisual Technology: Virtual Travel to Support Wellbeing and Quality of Life at the End of Life

A study testing 'LIFEView' in people with Palliative Care and Terminal Illness, run by Bruyère Health Research Institute. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is looking to assess the use of an audio-video technology called 'LIFEView' using a laptop and large-screen TV. This tool intends to support life review or reminiscence of past experiences, escape from current surroundings using virtual travel, or virtual visits to a location that one might have liked to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Palliative Care, Terminal Illness, Quality of Life
What is being tested?
'LIFEView'
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteCanada
Study dates
16 Oct 2019to 31 Dec 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Any patients who are able to complete the outcome measures (Section 5.0 Outcomes) and capable of consenting to participating in the research study will be included.

Who cannot join

  • Patients experiencing the following, as determined by the clinical care team:
  • Delirium
  • Severe cognitive impairment (as determined by the clinical care team)
  • Known behavioural abnormalities (e.g. overtly aggressive behavior) that in the opinion of the clinical care team might impede any meaningful participation in the project
  • A score of <30% on the Palliative Performance Scale (PPS) (Anderson et al., 1996) at the time of consent
  • Individuals who are already currently using Motiview paired with a exercise bicycle in the LTC setting
  • Those who are in the opinion of attending physician or clinical team too unwell to participate in the project
  • Unable to complete outcome measures indicated

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Bruyere Continuing Care

    Ottawa, Ontario, K1N 5C8

Other trials in Canada

About this study

This study is looking to assess the use of an audio-video technology called 'LIFEView' using a laptop and large-screen TV. This tool intends to support life review or reminiscence of past experiences, escape from current surroundings using virtual travel, or virtual visits to a location that one might have liked to visit in their lifetime but could not. We hope that by using this technology, we can support better wellbeing and quality of life for patients receiving palliative care services within the community and on an inpatient palliative care unit, or for patients at the end-of-life within Bruyère long-term care homes.

Due to the potential for disorientation and reduced physical mobility, patients receiving palliative and end-of-life care may be unable to fully enjoy an immersive experience using a virtual reality (VR) headset. To reduce the possibility of disorientation that may arise from using a VR headset with 'LIFEView', our research team will use the 'LIFEView' prototype software loaded on a laptop and connected to a mobile high-definition 50" TV for inpatient PCU and LTC facility use, or to a patient's personal TV within their residence in the community. This setup will also improve accessibility to 'LIFEView' as a result of its relatively low-tech requirements (i.e. TV + laptop), and allows for an opportunity for patients and their loved ones to share cherished memories and stories.

Read the detailed description

This project is designed to address the psychosocial and existential suffering commonly experienced by palliative care patients. Technology-based reminiscence and dignity therapy interventions have been demonstrated to improve well-being and quality of life in older adults (Lazar et al, 2014), although little evidence exists to support the use of these technology-based interventions in a palliative care context.

These technologies may require modification to meet the needs of PEOLC patients that are at risk for delirium, a neuropsychiatric condition characterized by fluctuating disruptions in awareness, focus and cognition (American Psychiatric Association, 2013). Delirium can be experienced by up to 88% of patients at the end of life (Hosie et al., 2013). Moreover, patients in PEOLC settings may also have limited mobility or may be bedbound. Due to the potential for disorientation and reduced physical mobility, patients receiving PEOLC may be unable to fully enjoy an immersive experience using a virtual reality (VR) headset. To reduce the possibility of disorientation that may arise from using a VR headset with 'LIFEView', our research team plans to use the 'LIFEView' prototype software loaded on a laptop and connected to a mobile high-definition 40-42" TV for inpatient PCU and LTC facility use, or to a patient's personal TV within their residence in the community.

Being tested
'LIFEView'
Keywords
Life review, Reminiscence, Technology, Existential distress, Virtual travel, Well-being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 'LIFEView'Other

    A prototype audiovisual technology in development by Motitech AS.

Study groups in NCT04030910
Study groupRoleWhat they receive
'LIFEView' interventionExperimentalThe 'LIFEView' session(s) involves the use of audiovisual software by Motitech AS (technology provided by and used with permission from Motitech AS). For its primary uses as Motiview, the audiovisual software was coupled to a mobile user-adapted cycle-trainer. Since a secondary benefit of the virtual cycle trip may include reminiscence which may in-turn facilitate conversation of past experiences, the audiovisual software is being adapted for use in reminiscence therapy for a palliative care population. As there is an extensive library available to participants and 'LIFEView' sessions could potentially be longer than feasible for research personnel to conduct, each 'LIFEView' session will be limited to up to 3 videos per session or up to 1 hour of videos per session, whichever is a shorter duration. Additional post-study 'LIFEView' sessions can be provided upon request from participants.
Receives: Other: 'LIFEView'

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in psychological and physical symptoms measured by the Edmonton Symptom Assessment System-revised (ESAS-r) (Bruera et al., 1991; Watanabe et al., 2011)

    The ESAS-r is a 9-item symptom assessment tool that assesses pain, tiredness, drowsiness, nausea, lack of appetite, shortness of breath, depression, anxiety, and feeling of wellbeing. Each item is rated by patients on a 0-10 scale (0= best possible, 10= worst possible).

    Measured: At least 24 hours before using 'LIFEView', and directly after and 48 hours after using 'LIFEView' (pre- and post-'LIFEView')

Secondary outcomes (4)
  1. Change in quality of life measured by the McGill Quality of Life-Revised questionnaire (Cohen et al., 2017)

    The MQOL-R will be used to assess patient quality of life. There are 4 parts to the questionnaire on overall quality of life, physical symptoms, feelings and thoughts, and social aspects of the participant's life. Each statement is rated on a 0-10 scale (0= worst possible,10= best possible).

    Measured: At least 24 hours before using 'LIFEView', and 48 hours after using 'LIFEView' (pre- and post-'LIFEView')

  2. Psychosocial effects and aspects of quality of life as determined by semi-structured interviews for consenting participants and their consenting family member(s) or caregiver(s).

    These interviews will explore the impact of the 'LIFEView' intervention on patient quality of life, patient-family and patient-caregiver interactions, perceptions of the 'LIFEView' intervention as a tool to improve well-being and quality of life in palliative care settings, and feasibility of using volunteer services to support the long-term sustainability of this intervention across care settings.

    Measured: Within 24 hours of using 'LIFEView' (post-'LIFEView')

  3. Change in heart rate

    Heart rate (beats per minute; bpm) will be measured using a wireless cuff.

    Measured: At least 24 hours before using 'LIFEView', and directly after using 'LIFEView' (pre- and post-'LIFEView')

  4. Change in blood pressure

    Blood pressure (mm Hg) will be measured using a wireless cuff.

    Measured: At least 24 hours before using 'LIFEView', and directly after using 'LIFEView' (pre- and post-'LIFEView')

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2019
  2. Study start16 Oct 2019
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
All eligible patients will be recruited to receive the intervention ("LIFEView").
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04030910
Sponsor's protocol ID
LIFEView 2
Status last verified
Mar 2023
First submitted
19 Jul 2019
Last updated
3 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang CW, Chow AY, Chan CL. The effects of life review interventions on spiritual well-being, psychological distress, and quality of life in patients with terminal or advanced cancer: A systematic review and meta-analysis of randomized controlled trials. Palliat Med. 2017 Dec;31(10):883-894. doi: 10.1177/0269216317705101. Epub 2017 May 10.

    PubMed 28488923
  • Ando M, Tsuda A, Morita T. Life review interviews on the spiritual well-being of terminally ill cancer patients. Support Care Cancer. 2007 Feb;15(2):225-31. doi: 10.1007/s00520-006-0121-y. Epub 2006 Sep 12.

    PubMed 16967303
  • Warth M, Kessler J, Koehler F, Aguilar-Raab C, Bardenheuer HJ, Ditzen B. Brief psychosocial interventions improve quality of life of patients receiving palliative care: A systematic review and meta-analysis. Palliat Med. 2019 Mar;33(3):332-345. doi: 10.1177/0269216318818011. Epub 2019 Jan 16. No abstract available.

    PubMed 30648926
  • Lazar A, Thompson H, Demiris G. A systematic review of the use of technology for reminiscence therapy. Health Educ Behav. 2014 Oct;41(1 Suppl):51S-61S. doi: 10.1177/1090198114537067.

    PubMed 25274711
  • Hosie A, Davidson PM, Agar M, Sanderson CR, Phillips J. Delirium prevalence, incidence, and implications for screening in specialist palliative care inpatient settings: a systematic review. Palliat Med. 2013 Jun;27(6):486-98. doi: 10.1177/0269216312457214. Epub 2012 Sep 17.

    PubMed 22988044
  • Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9.

    PubMed 1714502
  • Watanabe SM, Nekolaichuk C, Beaumont C, Johnson L, Myers J, Strasser F. A multicenter study comparing two numerical versions of the Edmonton Symptom Assessment System in palliative care patients. J Pain Symptom Manage. 2011 Feb;41(2):456-68. doi: 10.1016/j.jpainsymman.2010.04.020. Epub 2010 Sep 15.

    PubMed 20832987
  • Kinney JM, Rentz CA. Observed well-being among individuals with dementia: Memories in the Making, an art program, versus other structured activity. Am J Alzheimers Dis Other Demen. 2005 Jul-Aug;20(4):220-7. doi: 10.1177/153331750502000406.

    PubMed 16136845
  • Anderson F, Downing GM, Hill J, Casorso L, Lerch N. Palliative performance scale (PPS): a new tool. J Palliat Care. 1996 Spring;12(1):5-11.

    PubMed 8857241
  • Lee JS, Hurley MJ, Carew D, Fisher R, Kiss A, Drummond N. A randomized clinical trial to assess the impact on an emergency response system on anxiety and health care use among older emergency patients after a fall. Acad Emerg Med. 2007 Apr;14(4):301-8. doi: 10.1197/j.aem.2006.11.017. Epub 2007 Mar 1.

    PubMed 17331915
  • Stromgren AS, Goldschmidt D, Groenvold M, Petersen MA, Jensen PT, Pedersen L, Hoermann L, Helleberg C, Sjogren P. Self-assessment in cancer patients referred to palliative care: a study of feasibility and symptom epidemiology. Cancer. 2002 Jan 15;94(2):512-20. doi: 10.1002/cncr.10222.

    PubMed 11900236
  • Bernard H. Research Methods in Anthropology: Qualitative and Quantitative Approaches. 2nd ed. Thousand Oaks, CA: Sage Publications; 1995 1995.

  • Patton M. Qualitative Research and Evaluation Methods. 4th ed. Thousand Oaks, CA: Sage Publications, Inc; 2015.

  • Guest G, Bunce A, Johnson L. How Many Interviews Are Enough ? An Experiment with Data Saturation and Variability. Fam Heal Int 2006;18(1):59-82 doi:10.1177/1525822X05279903.

  • Mitchell AJ, Meader N, Symonds P. Diagnostic validity of the Hospital Anxiety and Depression Scale (HADS) in cancer and palliative settings: a meta-analysis. J Affect Disord. 2010 Nov;126(3):335-48. doi: 10.1016/j.jad.2010.01.067. Epub 2010 Mar 5.

    PubMed 20207007

Questions about this trial

What is this clinical trial studying?

A study testing 'LIFEView' in people with Palliative Care and Terminal Illness, run by Bruyère Health Research Institute. at 1 site in Canada.

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 1 inclusion and 8 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: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in psychological and physical symptoms measured by the Edmonton Symptom Assessment System-revised (ESAS-r) (Bruera et al., 1991; Watanabe et al., 2011) (time frame: At least 24 hours before using 'LIFEView', and directly after and 48 hours after using 'LIFEView' (pre- and post-'LIFEView')). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04030910, which also lists 23 linked publications.

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 3 Mar 2023.

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