Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 4 for:    8857241 [PUBMED-IDS]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04030910
Recruitment Status : Not yet recruiting
First Posted : July 24, 2019
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
Bruyere Continuing Care
Information provided by (Responsible Party):
Bruyere Research Institute

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 40-42" 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.


Condition or disease Intervention/treatment Phase
Palliative Care Terminal Illness Quality of Life Psychological Distress Other: "LIFEView" Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All eligible patients will be recruited to receive the intervention ("LIFEView").
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: "LIFEView" Audiovisual Technology: Virtual Travel to Support Wellbeing and Quality of Life at the End of Life
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: "LIFEView" intervention

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"
An audiovisual technology in development by Motitech AS.




Primary Outcome Measures :
  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) [ Time Frame: At least 24 hours before using 'LIFEView', and directly after and 48 hours after using 'LIFEView' (pre- and post-'LIFEView') ]
    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).


Secondary Outcome Measures :
  1. Change in quality of life measured by the McGill Quality of Life-Revised questionnaire (Cohen et al., 2017) [ Time Frame: At least 24 hours before using 'LIFEView', and 48 hours after using 'LIFEView' (pre- and post-'LIFEView') ]
    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).

  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). [ Time Frame: Within 24 hours of using 'LIFEView' (post-'LIFEView') ]
    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.

  3. Change in heart rate [ Time Frame: At least 24 hours before using 'LIFEView', and directly after using 'LIFEView' (pre- and post-'LIFEView') ]
    Heart rate (beats per minute; bpm) will be measured using a wireless cuff.

  4. Change in blood pressure [ Time Frame: At least 24 hours before using 'LIFEView', and directly after using 'LIFEView' (pre- and post-'LIFEView') ]
    Blood pressure (mm Hg) will be measured using a wireless cuff.

  5. Change in 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 [ Time Frame: From initiation of the 'LIFEView' session and directly after using 'LIFEView' (during and post-'LIFEView') ]

    The Greater Cincinnati Chapter Well-Being Observation tool will be used by the research team members to assess each patient's state of general well-being. There are 6 domains, for which each statement is rated on a 0-4 scale (0= never, 1= rarely, 2= some of the time, 3= most of the time, 4= always).

    Observational field notes will be taken by the Research Coordinator during the course of study participation on observable phenomena before, during, and after the 'LIFEView' session (e.g. verbalized reminiscence, feelings… etc.). Patients and their family members will only be identified by their participant study ID in field notes.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030910


Contacts
Layout table for location contacts
Contact: Monisha Kabir 613-562-6262 ext 1590 mkabir@bruyere.org

Sponsors and Collaborators
Bruyere Research Institute
Bruyere Continuing Care
Investigators
Layout table for investigator information
Principal Investigator: Rebekah Hackbusch Bruyère Continuing Care
Principal Investigator: Jill Rice, MD, CCFP(PC) Bruyère Continuing Care

Publications:
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.
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.

Layout table for additonal information
Responsible Party: Bruyere Research Institute
ClinicalTrials.gov Identifier: NCT04030910     History of Changes
Other Study ID Numbers: LIFEView 2
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bruyere Research Institute:
Life review
Reminiscence
Technology
Existential distress
Virtual travel
Well-being