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Virtual Reality for Mental Well-being in Older People With Physical Disabilities

  • NCT ID: NCT05818579
  • Time Stamp: February 14, 2024
  • Source Node: 146089
  • Name: Fowie Ng, PhD
  • Email: fowieng@twc.edu.hk
  • Phone: 852-34686789
  • Objectives This study aims to examine the effects of the therapeutic virtual reality (VR) experience in older people with physical disabilities in long-term care facilities (LTCF) in 1) increasing mental well-being, 2) reducing depressive symptoms, 3) reducing loneliness, 4) increasing health-related quality of life, and 5) increasing perceived social support. If this intervention is successful, this study will yield new knowledge about the effects of this innovative intervention. Also, an innovative VR intervention will be available to promote the mental well-being of older residents in LTCF. Trial design This study employs a single-blinded, two-parallel-group (intervention-to-control group ratio=1:1), non-inferiority, randomized controlled trial. Study setting This study will be conducted in the LTCF. Participants will be recruited from Care & Attention Homes for the Elderly and Nursing Homes under the governance of the Social Welfare Department in Hong Kong. Eligibility criteria Inclusion: 1) Aged 60 years or above; 2) LTCF residents; and 3) Physical disability, defined as the Modified Barthel Index (MBI) score of ≤ 90 (i.e., moderately dependent or worse). Exclusion: 1) Probably dementia, as defined by a Montreal Cognitive Assessment score of < 20, 2) Severe visual impairment, as defined by a lens-corrected visual acuity score of < 6/60, 3) Severe hearing impairment, as defined by failed whispered voice test, 4) Bilateral upper limb paralysis, as defined by the Medical Research Council Muscle Power Scale of < 4, or 5) Participated in any VR activities in the past six months or concurrently. Consent All participants will be asked to give their written informed consent to participate in the proposed study. Groups Participants allocated to the intervention group will participate in the 6-week VR experience programme. Participants allocated to the control will receive the usual care provided by the LTCF, such as personal care, regular basic medical and nursing care, and social support, as committed by the Social Welfare Department. The participants allocated to the intervention group receive the same usual care provided by the LTCF. The research team does not interfere with the services provided to the participants in either group. Outcomes Demographic data including age, gender, level of education, number of chronic illnesses, length of stay in the LTCF, and experience of participation in VR activities will be collected. Outcomes include mental well-being, depressive symptoms, loneliness, health-related quality of life, and perceived social support. Participant timeline Potential participants will be recruited in the phase of Enrolment, in which the eligibility screen and informed consent will be implemented. Then, in the phase of the Pre-treatment Assessment (i.e., T0,), demographic and outcome data will be collected. Subsequently, in the phase allocation, participants will be randomly allocated to either the therapeutic virtual reality experience group or the control group. Then, interventions will be implemented. In the phase of the Post-treatment Assessment (i.e., T1), outcome data will be collected once again. Analysis methods Demographic and outcome data collected at baseline will be reported either as means with standard deviation or as frequencies with percentages according to their levels of measurement as a whole sample and by groups. Generalized estimating equations (GEE) will be employed to separately test the hypothesis on the five outcomes as dependent variables (i.e., mental well-being, depressive symptoms, loneliness, health-related quality of life, perceived social support), The independent variables will be the same across all GEEs: group (two categories: intervention and control groups), timepoint (two categories: T0 and T1), and group x timepoint. The primary interpretation of the results will be based on the intention-to-treat analysis without adjusting for covariates. The level of significance will be set at 0.05. Missing data will be managed following a practical guide with flowcharts using various methods (e.g., multiple imputation, single imputation, or no imputation).

Studies

Study First Submitted Date 2023-04-05
Study First Posted Date 2023-04-19
Last Update Posted Date 2023-04-19
Start Month Year February 15, 2024
Primary Completion Month Year February 14, 2025
Verification Month Year April 2023
Verification Date 2023-04-30
Last Update Posted Date 2023-04-19

Conditions

Sequence: 52434269 Sequence: 52434270
Name Mental Health Wellness 1 Name Physical Disability
Downcase Name mental health wellness 1 Downcase Name physical disability

Id Information

Sequence: 40345923
Id Source org_study_id
Id Value MHI2_0071

Design Groups

Sequence: 55884980 Sequence: 55884981
Group Type Experimental Group Type No Intervention
Title Virtual reality Title Usual care
Description The investigators will administer a virtual reality experience programme to promote mental wellbeing of the participants Description The investigators will not provide any interventions to the participants.

Interventions

Sequence: 52743675
Intervention Type Other
Name Virtual reality experience
Description The VR experience is launched on the participants using all-in-one VR head-mount devices. Tablet computers are used to optimize the settings by the intervention facilitators. Each session lasts for approximately one hour with 10 minutes spent on the briefing, 20 minutes spent on the VR experience, and 30 minutes spent on the post-VR group discussion. There are two sessions per week. The whole course lasts for six weeks and there are a total of 12 sessions.

Keywords

Sequence: 80224396 Sequence: 80224397 Sequence: 80224398 Sequence: 80224399
Name Mental wellbeing Name Virtual reality Name Physical disability Name Older people
Downcase Name mental wellbeing Downcase Name virtual reality Downcase Name physical disability Downcase Name older people

Design Outcomes

Sequence: 178367862 Sequence: 178367863 Sequence: 178367864 Sequence: 178367865 Sequence: 178367866
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Mental well-being Measure Depressive symptoms Measure Loneliness Measure Health-related quality of life Measure Perceived social support
Time Frame 6 weeks Time Frame 6 weeks Time Frame 6 weeks Time Frame 6 weeks Time Frame 6 weeks
Description The World Health Organization Five Well-being Index will be used to measure mental well-being. Description The 9-item Patient Health Questionnaire will be used to measure depressive symptoms over the past two weeks. Description The Chinese version of the 6-item De Jong Gierveld Loneliness Scale will be used to measure loneliness. Description The Hong Kong version of the EuroQol 5-dimensions instrument with a five-level scale will be used to measure health-related quality of life. Description The Chinese version of the Multiple Scale of Perceived Social Support (MSPSS) will be used to measure perceived social support.

Sponsors

Sequence: 48562811 Sequence: 48562812 Sequence: 48562813 Sequence: 48562814
Agency Class OTHER Agency Class OTHER Agency Class UNKNOWN Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Tung Wah College Name Chinese University of Hong Kong Name Golden Age Foundation Name Pok Oi Hospital

Central Contacts

Sequence: 12077583 Sequence: 12077584
Contact Type primary Contact Type backup
Name Rick Kwan, PhD Name Fowie Ng, PhD
Phone 852-34686813 Phone 852-34686789
Email rickkwan@twc.edu.hk Email fowieng@twc.edu.hk
Phone Extension 6813 Phone Extension 6789
Role Contact Role Contact

Design Group Interventions

Sequence: 68509068
Design Group Id 55884980
Intervention Id 52743675

Eligibilities

Sequence: 30916066
Gender All
Minimum Age 60 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria: Aged 60 years or above; LTCF residents; and Physical disability, defined as the Modified Barthel Index (MBI) score of ≤ 90 (i.e., moderately dependent or worse). Exclusion Criteria: Probably dementia, as defined by a Montreal Cognitive Assessment (MoCA) score of < 20, Severe visual impairment, as defined by a lens-corrected visual acuity score of < 6/60, Severe hearing impairment, as defined by failed whispered voice test. Bilateral upper limb paralysis, as defined by the Medical Research Council Muscle Power Scale of < 4. or Participated in any virtual reality activities in the past six months or concurrently.
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254181116
Registered In Calendar Year 2023
Were Results Reported False
Has Single Facility False
Minimum Age Num 60
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 4

Designs

Sequence: 30661752
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Masking Description In the proposed study, only the outcome assessor will be blinded to the group labels. Participants and interventionists are impossible to be blinded in this study. The group labels will not be known to the outcome assessors and will not appear on any documents that the outcome assessors can access. The participants, family members, and staff members of the LTCF are prohibited to disclose the group labels of the participants to the outcome assessors.
Outcomes Assessor Masked True

Links

Sequence: 4408136
Url https://www.healthbureau.gov.hk/en/fund/210700_mhifs/approved_projects_2.html
Description List of approved project, Mental Health Initiative Funding Scheme Phase 2, Health Bureau, Hong Kong Government

Responsible Parties

Sequence: 29028434
Responsible Party Type Sponsor

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