NCT04030910

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 16, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

3.2 years

First QC Date

July 19, 2019

Last Update Submit

March 2, 2023

Conditions

Keywords

Life reviewReminiscenceTechnologyExistential distressVirtual travelWell-being

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (4)

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

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

  • 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).

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

  • Change in heart rate

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

  • Change in blood pressure

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

Other Outcomes (1)

  • Aspects of participant's level of general well-being as per the Greater Cincinnati Chapter Well-Being Observation tool (Rentz, 2002; Kinney & Rentz, 2005) during the 'LIFEView' session, and other observable phenomena

    From initiation of the 'LIFEView' session and directly after using 'LIFEView' (during and post-'LIFEView')

Study Arms (1)

'LIFEView' intervention

EXPERIMENTAL

The '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.

Other: 'LIFEView'

Interventions

A prototype audiovisual technology in development by Motitech AS.

'LIFEView' intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bruyere Continuing Care

Ottawa, Ontario, K1N 5C8, Canada

Location

Related Publications (23)

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    PMID: 28488923BACKGROUND
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    PMID: 16967303BACKGROUND
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    PMID: 30648926BACKGROUND
  • 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.

    PMID: 25274711BACKGROUND
  • 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.

    PMID: 22988044BACKGROUND
  • 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.

    PMID: 1714502BACKGROUND
  • 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.

    PMID: 20832987BACKGROUND
  • 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.

    PMID: 16136845BACKGROUND
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    PMID: 8857241BACKGROUND
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    PMID: 17331915BACKGROUND
  • 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.

    PMID: 11900236BACKGROUND
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    BACKGROUND
  • Patton M. Qualitative Research and Evaluation Methods. 4th ed. Thousand Oaks, CA: Sage Publications, Inc; 2015.

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  • 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.

    BACKGROUND
  • 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.

    PMID: 20207007BACKGROUND
  • Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.

    PMID: 16204405BACKGROUND
  • Hickey G, Kipping C. A multi-stage approach to the coding of data from open-ended questions. Nurse Res. 1996 Oct 1;4(1):81-91. doi: 10.7748/nr.4.1.81.s9.

    PMID: 27707369BACKGROUND
  • Rentz CA. Memories in the making: outcome-based evaluation of an art program for individuals with dementing illnesses. Am J Alzheimers Dis Other Demen. 2002 May-Jun;17(3):175-81. doi: 10.1177/153331750201700310.

    PMID: 12083348BACKGROUND
  • American Psychiatric Association. Delirium due to a general medical condition. Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5). Arlington, VA: American Psychiatric Association; 2013. p. 596-602.

    BACKGROUND
  • Bedard G, Zeng L, Zhang L, Lauzon N, Holden L, Tsao M, Danjoux C, Barnes E, Sahgal A, Poon M, Chow E. Minimal clinically important differences in the Edmonton symptom assessment system in patients with advanced cancer. J Pain Symptom Manage. 2013 Aug;46(2):192-200. doi: 10.1016/j.jpainsymman.2012.07.022. Epub 2012 Nov 22.

    PMID: 23177724BACKGROUND
  • Mercadante S, Adile C, Lanzetta G, Mystakidou K, Maltoni M, Guilherme Soares L, De Santis S, Ferrera P, Valenti M, Rosati M, Rossi R, Cortegiani A, Masedu F, Marinangeli F, Aielli F. Personalized Symptom Goals and Patient Global Impression on Clinical Changes in Advanced Cancer Patients. Oncologist. 2019 Feb;24(2):239-246. doi: 10.1634/theoncologist.2017-0668. Epub 2018 May 16.

    PMID: 29769382BACKGROUND
  • Hui D, Bruera E. Minimal clinically important differences in the edmonton symptom assessment system: the anchor is key. J Pain Symptom Manage. 2013 Mar;45(3):e4-5. doi: 10.1016/j.jpainsymman.2012.12.003. No abstract available.

    PMID: 23465763BACKGROUND
  • Hui D, Shamieh O, Paiva CE, Khamash O, Perez-Cruz PE, Kwon JH, Muckaden MA, Park M, Arthur J, Bruera E. Minimal Clinically Important Difference in the Physical, Emotional, and Total Symptom Distress Scores of the Edmonton Symptom Assessment System. J Pain Symptom Manage. 2016 Feb;51(2):262-9. doi: 10.1016/j.jpainsymman.2015.10.004. Epub 2015 Oct 19.

    PMID: 26482223BACKGROUND

Study Officials

  • Rebekah Hackbusch

    Bruyère Continuing Care

    PRINCIPAL INVESTIGATOR
  • Jill Rice, MD, CCFP(PC)

    Bruyère Continuing Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: All eligible patients will be recruited to receive the intervention ("LIFEView").
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2019

First Posted

July 24, 2019

Study Start

October 16, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations