AgingNCT03784053
Virtual Reality and Occupational Performance, Satisfaction, and Quality of Life of Older Adults
An observational study of Aging, run by University of the Sciences in Philadelphia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Immersive virtual reality
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2019to 14 Jan 2020
- Phase
- Observational
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Older adults aged 55+ that attend Journey's Way
- Members need to attend least twice a week
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Journey's Way
Philadelphia, Pennsylvania, 19128
Sara Benham, OTD, OTR/L, 317-979-4461, s.benham@usciences.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging
- Being tested
- Immersive virtual reality
- Keywords
- Older adults, Virtual reality, Quality of life, Occupation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive virtual realityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Immersive virtual reality | Participants will receive eight 30-minute sessions of immersive virtual reality. Receives: Other: Immersive virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Canadian Occupational Therapy Performance Measure (COPM)
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.
Measured: 10 minutes
Secondary outcomes (1)
World Health Organization Quality of Life BREF (WHOQOL-BREF)
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start21 Jan 2019 (estimated)
- Primary completion31 Aug 2019 (estimated)
- Study completion14 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Sciences in Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Benham, University of the Sciences in Philadelphia
- Investigators
- Sara Benham, OTD, OTR/L, Principal investigator, University of the Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784053
- Sponsor's protocol ID
- 1341686
- Status last verified
- Jan 2019
- First submitted
- 19 Dec 2018
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Law, M., Baptiste, S., Carswell, A., McColl, M., Polatajko, H., & Pollock, N. (2005). Canadian occupational performance measure (4th ed.). Ottawa, Ont.: Canadian Association of Occupational Therapists.
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.
PubMed 9626712Trzepacz 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.
PubMed 26346644
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Immersive Virtual Reality on Perceived Occupational Performance, Perceived Occupational Satisfaction, and Quality of Life of Older Adults
- ClinicalTrials.gov ID
- NCT03784053
- Acronym / sponsor ID
- 1341686
- Conditions
- Aging
- Keywords
- Older adults, Virtual reality, Quality of life, Occupation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of the Sciences in PhiladelphiaUniversity, hospital or other
- Study start
- 21 Jan 2019 (estimated)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 14 Jan 2020 (estimated)
- First posted
- 21 Dec 2018 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immersive virtual reality | – | Other: Immersive virtual realityParticipants will receive eight 30-minute sessions of immersive virtual reality. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Older adults aged 55+ that attend Journey's Way
- Members need to attend least twice a week
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Immersive virtual realityAt 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. | Other | Immersive virtual reality |
Primary outcome
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.
1 secondary outcome
World Health Organization Quality of Life BREF (WHOQOL-BREF)
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- BackgroundLaw, M., Baptiste, S., Carswell, A., McColl, M., Polatajko, H., & Pollock, N. (2005). Canadian occupational performance measure (4th ed.). Ottawa, Ont.: Canadian Association of Occupational Therapists.
- Background: PubMed 9626712Development 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.
- Background: PubMed 26346644Trzepacz 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.
- 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.
Sara Benham, OTD, OTR/L principal investigator
University of the Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by University of the Sciences in Philadelphia at 1 site in United States.
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 2 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 16 Jan 2019. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Benham, OTD, OTR/L (317-979-4461, s.benham@usciences.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Canadian Occupational Therapy Performance Measure (COPM) (time frame: 10 minutes). 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 NCT03784053, which also lists 3 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 16 Jan 2019.