Clinical trial NCT05818579: Virtual Reality for Mental Well-being in Older People With Physical Disabilities
Official title: The Effects of Therapeutic Virtual Reality Experience to Promote Mental Well-being in Older People Living With Physical Disabilities in Long-term Care Facilities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Wellness 1
Physical Disability
Keywords: Mental wellbeing
Virtual reality
Physical disability
Older people
Lead sponsor: Tung Wah College
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
name: Golden Age Foundation
name: Pok Oi Hospital
First posted: 2023-04-19
Enrollment: 216
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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.

Primary outcomes:
measure: Mental well-being
timeFrame: 6 weeks
Secondary outcomes:
measure: Depressive symptoms
timeFrame: 6 weeks
measure: Loneliness
timeFrame: 6 weeks
measure: Health-related quality of life
timeFrame: 6 weeks
measure: Perceived social support
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
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