NCT03784053

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 21, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2020

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

December 19, 2018

Last Update Submit

January 15, 2019

Conditions

Keywords

Older adultsVirtual realityQuality of lifeOccupation

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 minutes

Secondary Outcomes (1)

  • World Health Organization Quality of Life BREF (WHOQOL-BREF)

    10 minutes

Study Arms (1)

Immersive virtual reality

Participants will receive eight 30-minute sessions of immersive virtual reality.

Other: Immersive virtual reality

Interventions

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.

Immersive virtual reality

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Older adults aged 55+ that attend Journey's Way
  • Members need to attend least twice a week

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Journey's Way

Philadelphia, Pennsylvania, 19128, United States

RECRUITING

Related Publications (3)

  • 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.

    BACKGROUND
  • 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.

    PMID: 9626712BACKGROUND
  • 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.

    PMID: 26346644BACKGROUND

Study Officials

  • Sara Benham, OTD, OTR/L

    University of the Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Benham, OTD, OTR/L

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and Director of Doctoral Projects

Study Record Dates

First Submitted

December 19, 2018

First Posted

December 21, 2018

Study Start

January 21, 2019

Primary Completion

August 31, 2019

Study Completion

January 14, 2020

Last Updated

January 16, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations