Older Adults Institutionalized in Residential HomesNCT07879677
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
A study testing Psychological intervention in people with Older Adults Institutionalized in Residential Homes, run by Tung Wah College.
Trial summary
This project will evaluate how well the immersive virtual reality psychological program works in residential care homes and how it can be used in everyday practice. We will test its effects on mood, well-being, social connection, and related outcomes, while also examining what helps or hinders delivery in real-world… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Older Adults Institutionalized in Residential Homes
- What is being tested?
- Psychological intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 13 Oct 2026to 11 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 years or above
- Current resident of a residential care home
- Physical disability indicated by a Modified Barthel Index (MBI) score ≤ 90 (i.e., moderately dependent or worse)
Who cannot join
- Probable dementia, defined by a Mainland Chinese version of the Montreal Cognitive Assessment score
- Severe visual impairment, defined as best-corrected visual acuity < 6/60
- Severe hearing impairment, indicated by a failed whisper voice test [27],
- Bilateral upper-limb paralysis, defined by a Medical Research Council Muscle Power Scale score < 4
- Participation in any virtual reality program within the past six months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects of a Therapeutic Immersive Virtual Reality Program for Residential Care Home Older Adults Living With Physical Disabilities: A Hybrid Type 1 Effectiveness - Implementation Trial
This project will evaluate how well the immersive virtual reality psychological program works in residential care homes and how it can be used in everyday practice. We will test its effects on mood, well-being, social connection, and related outcomes, while also examining what helps or hinders delivery in real-world settings, including any adaptations needed to make routine use feasible.
It is needed to close the gap between success shown in controlled research and the realities of daily care, where staffing, management support, and diverse resident needs can affect results. By studying effectiveness and implementation together, we can learn whether the program works across different homes and how to sustain it over time.
Residents may benefit through improved mood, well-being, and feelings of social support. Care homes may gain an engaging, adaptable activity that fits limited mobility and sensory needs, and the broader community and policymakers may receive practical guidance to implement, scale, and maintain an evidence-based mental health program for older adults in residential care.
Read the detailed description
This study uses a Type 1 hybrid effectiveness-implementation design with a single-blind, two-arm, three-matched-pair cluster randomized controlled trial (cRCT) and mixed-methods evaluation. Residential homes serve as clusters to minimize contamination, improve efficiency, and enhance real-world applicability. The trial follows SPIRIT guidelines and will recruit 400 participants from six residential homes in Sichuan Province, China.
Homes will be matched and randomized to intervention or usual care. Written informed consent will be obtained after full explanation of procedures, risks, and benefits, following ethics approval and the Declaration of Helsinki.
Intervention and Procedures
Intervention (IVRPP): 12 sessions (~60 minutes each) delivered twice weekly over 6 weeks by trained college student volunteers. Each session includes ~10 min briefing, ~30 min immersive VR (Natural Scenes, Tourism, or Reminiscence via Oculus Quest 2), and ~10 min debrief. Sessions occur in small groups (2-3 participants) with nurse oversight and real-time tablet monitoring. Safety protocols include seated positioning and 10-minute postsession observation for VR sickness.
Control: Usual care only.
Justification: The program integrates evidence-based immersive VR with intergenerational support to improve mental well-being in a scalable, low-resource format suitable for residential care.
Assessments (T0: baseline, T1: post-intervention, T2: 3-month follow-up):
- Primary: GAD-7 and PHQ-9 (~5-10 min).
- Secondary: WHO-5, curiosity scale, loneliness scale, TALE reminiscence, EQ-5D-5L (~20-30 min total per timepoint).
Implementation evaluation (RE-AIM framework): Quantitative indicators (recruitment, fidelity, retention) plus semi-structured interviews with staff/leaders (~30-45 min) and participant exit interviews (~10-20 min).
Data Analysis Quantitative: Data will be analyzed using descriptive statistics and generalized estimating equations (GEE) Qualitative: Thematic analysis of interview transcripts. Mixed-methods triangulation will link effectiveness and implementation findings.
Roles and Timeline
- Research team: Lead design, training, oversight, and analysis.
- Service team (college faculty/students, home staff): Co-implementation, scheduling, and supervision. Nurse coordinates clinical aspects.
Timeline (approx. 9-18 months total):
- Months 1-3: Preparation and baseline.
- Months 4-15: Intervention delivery.
- Months 16-18: Follow-ups, interviews, and analysis.
This pragmatic design rigorously evaluates both effectiveness and real-world implementability while keeping participant burden low.
- Being tested
- Psychological intervention
- Keywords
- immersive virtual reality, mental health, depression, loneliness, health-related quality of life, older people
- Medical subject headings
- Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological interventionOther
Intervention (IVRPP): 12 sessions (~60 minutes each) delivered twice weekly over 6 weeks by trained college student volunteers. Each session includes ~10 min briefing, ~30 min immersive VR (Natural Scenes, Tourism, or Reminiscence via Oculus Quest 2), and ~10 min debrief. Sessions occur in small groups (2-3 participants) with nurse oversight and real-time tablet monitoring. Safety protocols include seated positioning and 10-minute post-session observation for VR sickness.
| Study group | Role | What they receive |
|---|---|---|
| IVR Therapeutic Program | Experimental | Immersive Virtual Reality (Natural Scenes, Tourism, or Reminiscence via Oculus Quest 2) Receives: Other: Psychological intervention |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAD-7
Depression
Measured: From enrollment to the end of intervention and three-month follow-up
PHQ-9
Anxiety
Measured: From enrollment to the end of intervention and three-month follow-up
Secondary outcomes (5)
World Health Organization-Five Well-Being Index (WHO-5)
Well-being
Measured: From enrolment to the end of intervention and three-month follow-up
Curiosity Scale
Curiosity
Measured: From enrolment to the end of intervention and three-month follow-up
Loneliness Scale
Loneliness
Measured: From enrolment to the end of intervention and three-month follow-up
Thinking About Life Experiences (TALE) Reminiscence
Reminiscence
Measured: From enrolment to the end of intervention and three-month follow-up
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
Quality of Life
Measured: From enrolment to the end of intervention and three-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start13 Oct 2026 (estimated)
- Primary completion11 Jun 2027 (estimated)
- Study completion11 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Older Adults Institutionalized in Residential HomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tung Wah College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879677
- Sponsor's protocol ID
- REC2026306
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant Privacy \& the Lack of Ethics Committee Approval for IPD sharing
Publications
Pachana NA. Using implementation science to progress psychogeriatrics. Int Psychogeriatr. 2021 Sep;33(9):847-849. doi: 10.1017/S1041610221001198. No abstract available.
PubMed 34607622Hawe P. Lessons from complex interventions to improve health. Annu Rev Public Health. 2015 Mar 18;36:307-23. doi: 10.1146/annurev-publhealth-031912-114421. Epub 2015 Jan 7.
PubMed 25581153Kwan RYC, Su JJ, Lee JLC, Ng F, Lai M, Lei C, Chan S. The effects of a therapeutic immersive virtual reality programme on the mental health of residential care home residents living with physical disabilities: A multi-centre randomised controlled trial. Int J Nurs Stud. 2026 Feb;174:105307. doi: 10.1016/j.ijnurstu.2025.105307. Epub 2025 Nov 25.
PubMed 41349267Johnson AL, Ecker AH, Fletcher TL, Hundt N, Kauth MR, Martin LA, Curran GM, Cully JA. Increasing the impact of randomized controlled trials: an example of a hybrid effectiveness-implementation design in psychotherapy research. Transl Behav Med. 2020 Aug 7;10(3):629-636. doi: 10.1093/tbm/iby116.
PubMed 30476315Wong AKC, Wong FKY, Chow KKS, Kwan DKS, Lau DYS, Lau ACK. A health-social service partnership programme for improving the health self-management of community-dwelling older adults: a hybrid effectiveness-implementation pilot study protocol. Pilot Feasibility Stud. 2023 Nov 8;9(1):184. doi: 10.1186/s40814-023-01412-0.
PubMed 37941087Batalden M, Batalden P, Margolis P, Seid M, Armstrong G, Opipari-Arrigan L, Hartung H. Coproduction of healthcare service. BMJ Qual Saf. 2016 Jul;25(7):509-17. doi: 10.1136/bmjqs-2015-004315. Epub 2015 Sep 16.
PubMed 26376674
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Therapeutic Immersive Virtual Reality Program for Residential Care Home Older Adults Living With Physical Disabilities: A Hybrid Type 1 Effectiveness - Implementation Trial
- ClinicalTrials.gov ID
- NCT07879677
- Acronym / sponsor ID
- REC2026306
- Keywords
- immersive virtual reality, mental health, depression, loneliness, health-related quality of life, older people
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tung Wah CollegeUniversity, hospital or other
- Study start
- 13 Oct 2026 (estimated)
- Primary completion
- 11 Jun 2027 (estimated)
- Study completion
- 11 Aug 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will evaluate how well the immersive virtual reality psychological program works in residential care homes and how it can be used in everyday practice. We will test its effects on mood, well-being, social connection, and related outcomes, while also examining what helps or hinders delivery in real-world settings, including any adaptations needed to make routine use feasible.
It is needed to close the gap between success shown in controlled research and the realities of daily care, where staffing, management support, and diverse resident needs can affect results. By studying effectiveness and implementation together, we can learn whether the program works across different homes and how to sustain it over time.
Residents may benefit through improved mood, well-being, and feelings of social support. Care homes may gain an engaging, adaptable activity that fits limited mobility and sensory needs, and the broader community and policymakers may receive practical guidance to implement, scale, and maintain an evidence-based mental health program for older adults in residential care.
Detailed description
This study uses a Type 1 hybrid effectiveness-implementation design with a single-blind, two-arm, three-matched-pair cluster randomized controlled trial (cRCT) and mixed-methods evaluation. Residential homes serve as clusters to minimize contamination, improve efficiency, and enhance real-world applicability. The trial follows SPIRIT guidelines and will recruit 400 participants from six residential homes in Sichuan Province, China.
Homes will be matched and randomized to intervention or usual care. Written informed consent will be obtained after full explanation of procedures, risks, and benefits, following ethics approval and the Declaration of Helsinki.
Intervention and Procedures
Intervention (IVRPP): 12 sessions (~60 minutes each) delivered twice weekly over 6 weeks by trained college student volunteers. Each session includes ~10 min briefing, ~30 min immersive VR (Natural Scenes, Tourism, or Reminiscence via Oculus Quest 2), and ~10 min debrief. Sessions occur in small groups (2-3 participants) with nurse oversight and real-time tablet monitoring. Safety protocols include seated positioning and 10-minute postsession observation for VR sickness.
Control: Usual care only.
Justification: The program integrates evidence-based immersive VR with intergenerational support to improve mental well-being in a scalable, low-resource format suitable for residential care.
Assessments (T0: baseline, T1: post-intervention, T2: 3-month follow-up):
- Primary: GAD-7 and PHQ-9 (~5-10 min).
- Secondary: WHO-5, curiosity scale, loneliness scale, TALE reminiscence, EQ-5D-5L (~20-30 min total per timepoint).
Implementation evaluation (RE-AIM framework): Quantitative indicators (recruitment, fidelity, retention) plus semi-structured interviews with staff/leaders (~30-45 min) and participant exit interviews (~10-20 min).
Data Analysis Quantitative: Data will be analyzed using descriptive statistics and generalized estimating equations (GEE) Qualitative: Thematic analysis of interview transcripts. Mixed-methods triangulation will link effectiveness and implementation findings.
Roles and Timeline
- Research team: Lead design, training, oversight, and analysis.
- Service team (college faculty/students, home staff): Co-implementation, scheduling, and supervision. Nurse coordinates clinical aspects.
Timeline (approx. 9-18 months total):
- Months 1-3: Preparation and baseline.
- Months 4-15: Intervention delivery.
- Months 16-18: Follow-ups, interviews, and analysis.
This pragmatic design rigorously evaluates both effectiveness and real-world implementability while keeping participant burden low.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVR Therapeutic Program | Experimental | Other: Psychological interventionImmersive Virtual Reality (Natural Scenes, Tourism, or Reminiscence via Oculus Quest 2) |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 60 years or above
- Current resident of a residential care home
- Physical disability indicated by a Modified Barthel Index (MBI) score ≤ 90 (i.e., moderately dependent or worse)
Key exclusion criteria (5 listed)
- Probable dementia, defined by a Mainland Chinese version of the Montreal Cognitive Assessment score
- Severe visual impairment, defined as best-corrected visual acuity < 6/60
- Severe hearing impairment, indicated by a failed whisper voice test [27],
- Bilateral upper-limb paralysis, defined by a Medical Research Council Muscle Power Scale score < 4
- Participation in any virtual reality program within the past six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological interventionIntervention (IVRPP): 12 sessions (~60 minutes each) delivered twice weekly over 6 weeks by trained college student volunteers. Each session includes ~10 min briefing, ~30 min immersive VR (Natural Scenes, Tourism, or Reminiscence via Oculus Quest 2), and ~10 min debrief. Sessions occur in small groups (2-3 participants) with nurse oversight and real-time tablet monitoring. Safety protocols include seated positioning and 10-minute post-session observation for VR sickness. | Other | IVR Therapeutic Program |
Primary outcome
GAD-7
Time frame: From enrollment to the end of intervention and three-month follow-up
Depression
PHQ-9
Time frame: From enrollment to the end of intervention and three-month follow-up
Anxiety
5 secondary outcomes
World Health Organization-Five Well-Being Index (WHO-5)
Time frame: From enrolment to the end of intervention and three-month follow-up
Curiosity Scale
Time frame: From enrolment to the end of intervention and three-month follow-up
Loneliness Scale
Time frame: From enrolment to the end of intervention and three-month follow-up
Thinking About Life Experiences (TALE) Reminiscence
Time frame: From enrolment to the end of intervention and three-month follow-up
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
Time frame: From enrolment to the end of intervention and three-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 34607622Pachana NA. Using implementation science to progress psychogeriatrics. Int Psychogeriatr. 2021 Sep;33(9):847-849. doi: 10.1017/S1041610221001198. No abstract available.
- Background: PubMed 25581153Hawe P. Lessons from complex interventions to improve health. Annu Rev Public Health. 2015 Mar 18;36:307-23. doi: 10.1146/annurev-publhealth-031912-114421. Epub 2015 Jan 7.
- Background: PubMed 41349267Kwan RYC, Su JJ, Lee JLC, Ng F, Lai M, Lei C, Chan S. The effects of a therapeutic immersive virtual reality programme on the mental health of residential care home residents living with physical disabilities: A multi-centre randomised controlled trial. Int J Nurs Stud. 2026 Feb;174:105307. doi: 10.1016/j.ijnurstu.2025.105307. Epub 2025 Nov 25.
- Background: PubMed 30476315Johnson AL, Ecker AH, Fletcher TL, Hundt N, Kauth MR, Martin LA, Curran GM, Cully JA. Increasing the impact of randomized controlled trials: an example of a hybrid effectiveness-implementation design in psychotherapy research. Transl Behav Med. 2020 Aug 7;10(3):629-636. doi: 10.1093/tbm/iby116.
- Background: PubMed 37941087Wong AKC, Wong FKY, Chow KKS, Kwan DKS, Lau DYS, Lau ACK. A health-social service partnership programme for improving the health self-management of community-dwelling older adults: a hybrid effectiveness-implementation pilot study protocol. Pilot Feasibility Stud. 2023 Nov 8;9(1):184. doi: 10.1186/s40814-023-01412-0.
- Background: PubMed 26376674Batalden M, Batalden P, Margolis P, Seid M, Armstrong G, Opipari-Arrigan L, Hartung H. Coproduction of healthcare service. BMJ Qual Saf. 2016 Jul;25(7):509-17. doi: 10.1136/bmjqs-2015-004315. Epub 2015 Sep 16.
- Individual participant dataSharing planned: No. Participant Privacy \& the Lack of Ethics Committee Approval for IPD sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological intervention in people with Older Adults Institutionalized in Residential Homes, run by Tung Wah College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rick Yiu Cho Kwan, PhD (+852 3468 6813, rickkwan@twc.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAD-7 (time frame: From enrollment to the end of intervention and three-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07879677, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.