<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03784053</url>
  </required_header>
  <id_info>
    <org_study_id>1341686</org_study_id>
    <nct_id>NCT03784053</nct_id>
  </id_info>
  <brief_title>Virtual Reality and Occupational Performance, Satisfaction, and Quality of Life of Older Adults</brief_title>
  <official_title>The Effect of Immersive Virtual Reality on Perceived Occupational Performance, Perceived Occupational Satisfaction, and Quality of Life of Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of the Sciences in Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of the Sciences in Philadelphia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Older adult participants will complete eight immersive virtual reality (VR) sessions with the&#xD;
      researcher, within five weeks (no more than two sessions per week may be scheduled). The&#xD;
      screening process and assessment measures are not included in the five weeks of virtual&#xD;
      reality. Sessions will consist of 30 minutes of use of the virtual reality goggles. During&#xD;
      the virtual reality sessions, participants will select from a list of Oculus Go apps related&#xD;
      to their self-identified occupational performance issues. Participants are expected to&#xD;
      complete the session while seated with the VR set secured on their head.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Virtual reality (VR) may promote engagement in meaningful daily activities that is tailored&#xD;
      to the individual's skill level, need, and significance to their individual context. There is&#xD;
      limited research on measurable changes in perceived meaningful daily activities after&#xD;
      utilizing immersive VR, specifically with a head mounted display. Only in recent years have&#xD;
      head-mounted displays become less expensive and more commercially available for research and&#xD;
      patron purchase. At the low cost of $250, the device is within the reach of many older adult&#xD;
      community centers for leisure and recreational use. The researchers will measure changes in&#xD;
      occupational performance, occupational satisfaction, and quality of life for the older adult&#xD;
      members of a community center, after eight immersive VR sessions. Sessions will consist of 30&#xD;
      minutes of use of the virtual reality goggles. During the virtual reality sessions,&#xD;
      participants will select from a list of Oculus Go apps related to their self-identified&#xD;
      occupational performance issues. Participants are expected to complete the session while&#xD;
      seated with the VR set secured on their head.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">January 21, 2019</start_date>
  <completion_date type="Anticipated">January 14, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The Canadian Occupational Therapy Performance Measure (COPM)</measure>
    <time_frame>10 minutes</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>World Health Organization Quality of Life BREF (WHOQOL-BREF)</measure>
    <time_frame>10 minutes</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Immersive virtual reality</arm_group_label>
    <description>Participants will receive eight 30-minute sessions of immersive virtual reality.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Immersive virtual reality</intervention_name>
    <description>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.</description>
    <arm_group_label>Immersive virtual reality</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The aim is to recruit community-dwelling, healthy older adults from one community center.&#xD;
        Subjects will be excluded if they receive a score of 17 or less on the MoCA because this&#xD;
        score is associated with individuals with Alzheimer's Disease (Trzepacz, Hochstetler, Wang,&#xD;
        Walker, &amp; Saykin, 2015). The second exclusion, for safety purposes, is recommended by the&#xD;
        Oculus Go user manual.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Older adults aged 55+ that attend Journey's Way&#xD;
&#xD;
          2. Members need to attend least twice a week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Score of 17 or less on the MoCA&#xD;
&#xD;
          2. A self-report a history of any of the following: Seizures, epilepsy, dizziness,&#xD;
             vertigo, or motion sickness, any current contagious skin and eye conditions,&#xD;
             experience sensitivity to light, have or use hearing aids, and a pacemaker and/or a&#xD;
             defibrillator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sara Benham, OTD, OTR/L</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of the Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sara Benham, OTD, OTR/L</last_name>
    <phone>317-979-4461</phone>
    <email>s.benham@usciences.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Journey's Way</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19128</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Benham, OTD, OTR/L</last_name>
      <phone>317-979-4461</phone>
      <email>s.benham@usciences.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Law, M., Baptiste, S., Carswell, A., McColl, M., Polatajko, H., &amp; Pollock, N. (2005). Canadian occupational performance measure (4th ed.). Ottawa, Ont.: Canadian Association of Occupational Therapists.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9626712</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26346644</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of the Sciences in Philadelphia</investigator_affiliation>
    <investigator_full_name>Sara Benham</investigator_full_name>
    <investigator_title>Assistant Professor and Director of Doctoral Projects</investigator_title>
  </responsible_party>
  <keyword>Older adults</keyword>
  <keyword>Virtual reality</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Occupation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03784053
org study id: 1341686
nct id: NCT03784053
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: The Canadian Occupational Therapy Performance Measure (COPM)
time frame: 10 minutes
description: 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.
measure: World Health Organization Quality of Life BREF (WHOQOL-BREF)
time frame: 10 minutes
description: 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.
arm group label: Immersive virtual reality
description: Participants will receive eight 30-minute sessions of immersive virtual reality.
intervention type: Other
intervention name: Immersive virtual reality
description: 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.
arm group label: Immersive virtual reality
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sara Benham, OTD, OTR/L
role: Principal Investigator
affiliation: University of the Sciences
last name: Sara Benham, OTD, OTR/L
phone: 317-979-4461
email: s.benham@usciences.edu
facility: 
status: Recruiting
contact: 
country: United States
citation: 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.
citation: 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: 9626712
citation: 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: 26346644
responsible party type: Principal Investigator
investigator affiliation: University of the Sciences in Philadelphia
investigator full name: Sara Benham
investigator title: Assistant Professor and Director of Doctoral Projects
sharing ipd: No