- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03784053
Virtual Reality and Occupational Performance, Satisfaction, and Quality of Life of Older Adults
January 15, 2019 updated by: Sara Benham, University of the Sciences in Philadelphia
The Effect of Immersive Virtual Reality on Perceived Occupational Performance, Perceived Occupational Satisfaction, and Quality of Life of Older Adults
Older adult participants will complete eight immersive virtual reality (VR) sessions with the researcher, within five weeks (no more than two sessions per week may be scheduled).
The screening process and assessment measures are not included in the five weeks of virtual reality.
Sessions will consist of 30 minutes of use of the virtual reality goggles.
During the virtual reality sessions, participants will select from a list of Oculus Go apps related to their self-identified occupational performance issues.
Participants are expected to complete the session while seated with the VR set secured on their head.
Study Overview
Detailed Description
Virtual reality (VR) may promote engagement in meaningful daily activities that is tailored to the individual's skill level, need, and significance to their individual context.
There is limited research on measurable changes in perceived meaningful daily activities after utilizing immersive VR, specifically with a head mounted display.
Only in recent years have head-mounted displays become less expensive and more commercially available for research and patron purchase.
At the low cost of $250, the device is within the reach of many older adult community centers for leisure and recreational use.
The researchers will measure changes in occupational performance, occupational satisfaction, and quality of life for the older adult members of a community center, after eight immersive VR sessions.
Sessions will consist of 30 minutes of use of the virtual reality goggles.
During the virtual reality sessions, participants will select from a list of Oculus Go apps related to their self-identified occupational performance issues.
Participants are expected to complete the session while seated with the VR set secured on their head.
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sara Benham, OTD, OTR/L
- Phone Number: 317-979-4461
- Email: s.benham@usciences.edu
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19128
- Recruiting
- Journey's Way
-
Contact:
- Sara Benham, OTD, OTR/L
- Phone Number: 317-979-4461
- Email: s.benham@usciences.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The aim is to recruit community-dwelling, healthy older adults from one community center.
Subjects will be excluded if they receive a score of 17 or less on the MoCA because this score is associated with individuals with Alzheimer's Disease (Trzepacz, Hochstetler, Wang, Walker, & Saykin, 2015).
The second exclusion, for safety purposes, is recommended by the Oculus Go user manual.
Description
Inclusion Criteria:
- Older adults aged 55+ that attend Journey's Way
- Members need to attend least twice a week
Exclusion Criteria:
- Score of 17 or less on the MoCA
- A self-report a history of any of the following: Seizures, epilepsy, dizziness, vertigo, or motion sickness, any current contagious skin and eye conditions, experience sensitivity to light, have or use hearing aids, and a pacemaker and/or a defibrillator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Immersive virtual reality
Participants will receive eight 30-minute sessions of immersive virtual reality.
|
At the start of every session, the participants' top five occupational problems will be reviewed, and a list of apps corresponding to the desired occupational problem will be offered through the immersive virtual reality device (Oculus Go).
There will be eight 30-minute virtual reality sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Canadian Occupational Therapy Performance Measure (COPM)
Time Frame: 10 minutes
|
The COPM is a standardized outcome measure that identifies an individual's perceived occupational performance and occupational satisfaction and detects change in these areas over time.
Through a semi-structured interview, individuals will identify their difficulties with self-care, leisure, and productivity (Law et al., 2005).
The client is asked to rate the importance of each of the occupations to his/her life using a 10-point rating scale (1 to 10).
Then, the client will rate the performance and satisfaction of the occupations on a 10-point rating scale (1 to 10).
Then, the average performance satisfaction is calculated (1 to 10) and the average satisfaction is calculated (1 to 10).
Higher scores indicate better outcomes.
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
World Health Organization Quality of Life BREF (WHOQOL-BREF)
Time Frame: 10 minutes
|
The WHOQOL-BREF is an assessment used to measure an individual's perceived quality of life.
It has 26 items across the following four domains: physical health, psychological health, social relationships, and environment.
Items are scored on a scale of 1 to 5 (a higher score is a more favorable outcome).
Raw scores are calculated of each domain, and then scores may be transformed to scores ranging from 4 to 20 within each domain.
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10 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sara Benham, OTD, OTR/L, University of the Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
- Trzepacz PT, Hochstetler H, Wang S, Walker B, Saykin AJ; Alzheimer's Disease Neuroimaging Initiative. Relationship between the Montreal Cognitive Assessment and Mini-mental State Examination for assessment of mild cognitive impairment in older adults. BMC Geriatr. 2015 Sep 7;15:107. doi: 10.1186/s12877-015-0103-3.
- McColl MA, Law M, Baptiste S, Pollock N, Carswell A, Polatajko HJ. Targeted applications of the Canadian Occupational Performance Measure. Can J Occup Ther. 2005 Dec;72(5):298-300. doi: 10.1177/000841740507200506.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 21, 2019
Primary Completion (Anticipated)
August 31, 2019
Study Completion (Anticipated)
January 14, 2020
Study Registration Dates
First Submitted
December 19, 2018
First Submitted That Met QC Criteria
December 19, 2018
First Posted (Actual)
December 21, 2018
Study Record Updates
Last Update Posted (Actual)
January 16, 2019
Last Update Submitted That Met QC Criteria
January 15, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 1341686
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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