## Protocol Section
### Identification Module
**NCT ID:** NCT05818579

**Brief Title:** 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

#### Organization Study ID Info
**ID:** MHI2_0071
#### Organization
**Class:** OTHER
**Full Name:** Tung Wah College
### Status Module
#### Completion Date
**Date:** 2025-05-14

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-04-19

**Type:** ACTUAL

**Last Update Submit Date:** 2023-04-05

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-02-14

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-15

**Type:** ESTIMATED

**Status Verified Date:** 2023-04

#### Study First Post Date
**Date:** 2023-04-19
**Type:** ACTUAL
**Study First Submit Date:** 2023-04-05
**Study First Submit QC Date:** 2023-04-05
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Chinese University of Hong Kong

**Class:** UNKNOWN

**Name:** Golden Age Foundation

**Class:** OTHER

**Name:** Pok Oi Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Tung Wah College

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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).

### Conditions Module

**Conditions:**

- Mental Health Wellness 1

- Physical Disability

**Keywords:**

- Mental wellbeing

- Virtual reality

- Physical disability

- Older people

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**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.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 216

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The investigators will administer a virtual reality experience programme to promote mental wellbeing of the participants

**Intervention Names:**

- Other: Virtual reality experience

**Label:** Virtual reality

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The investigators will not provide any interventions to the participants.

**Label:** Usual care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Virtual reality

**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.

**Name:** Virtual reality experience

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The World Health Organization Five Well-being Index will be used to measure mental well-being.

**Measure:** Mental well-being

**Time Frame:** 6 weeks

#### Secondary Outcomes

**Description:** The 9-item Patient Health Questionnaire will be used to measure depressive symptoms over the past two weeks.

**Measure:** Depressive symptoms

**Time Frame:** 6 weeks

**Description:** The Chinese version of the 6-item De Jong Gierveld Loneliness Scale will be used to measure loneliness.

**Measure:** Loneliness

**Time Frame:** 6 weeks

**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.

**Measure:** Health-related quality of life

**Time Frame:** 6 weeks

**Description:** The Chinese version of the Multiple Scale of Perceived Social Support (MSPSS) will be used to measure perceived social support.

**Measure:** Perceived social support

**Time Frame:** 6 weeks

### Eligibility Module

**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.

**Minimum Age:** 60 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rickkwan@twc.edu.hk

**Name:** Rick Kwan, PhD

**Phone:** 852-34686813

**Phone Ext:** 6813

**Role:** CONTACT

**Contact 2:**

**Email:** fowieng@twc.edu.hk

**Name:** Fowie Ng, PhD

**Phone:** 852-34686789

**Phone Ext:** 6789

**Role:** CONTACT

### IPD Sharing Statement Module

**Description:** The data will be provided upon request.

**IPD Sharing:** UNDECIDED

### References Module

#### See Also Links

**Label:** List of approved project, Mental Health Initiative Funding Scheme Phase 2, Health Bureau, Hong Kong Government

**URL:** https://www.healthbureau.gov.hk/en/fund/210700_mhifs/approved_projects_2.html

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
