REVI Pilot Feasibility Trial in Long-Term Care (NCT07742137) | Clinical Trial Compass
CompletedNot Applicable
REVI Pilot Feasibility Trial in Long-Term Care
Spain18 participantsStarted 2026-03-16
Plain-language summary
This pilot study evaluates the feasibility, safety, and acceptability of an immersive virtual reality (VR) intervention designed to promote psychological well-being in older adults living in a long-term care facility. The study examines whether an eight-session VR program can be delivered safely and comfortably, whether participants tolerate and engage with the sessions, and whether the intervention shows preliminary signals of benefit in emotional well-being and subjective experience of presence. The results will inform the design and implementation of a larger, ongoing study using the same protocol.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Residents of long-term care facilities.
* Age 65 years or older.
* Full functional independence (Barthel Index = 100).
* Adequate balance and gait to safely participate in VR sessions (Berg Balance Scale \> 45).
* Absence of significant cognitive impairment (MMSE ≥ 25 or CAMCOG-R ≥ 80).
* Absence of clinically significant depressive symptoms (GDS-SF ≤ 5).
* No prior experience with immersive virtual reality.
* Able to provide informed consent or have a legal representative who can do so.
* Able to remain seated for approximately 20 minutes per session.
* Willing to participate in eight VR sessions over four weeks.
Exclusion Criteria:
* Cognitive impairment that prevents understanding instructions or interacting with VR content.
* Depressive symptoms above the screening threshold established in the inclusion criteria.
* Balance or gait limitations judged by clinical staff to pose a safety risk during VR use.
* Medical or neurological conditions that contraindicate VR exposure (e.g., uncontrolled epilepsy, severe motion sickness).
* Acute medical instability or conditions requiring urgent clinical intervention.
* Any condition judged by clinical staff to pose a safety risk during VR immersion.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment Rate
Timeframe: At the end of the recruitment period (March 13, 2026).
2
Retention Rate
Timeframe: From enrollment through completion of the 4-week intervention period.
3
Adverse Events
Timeframe: From the first session through the final session of the 4-week intervention period.
4
Acceptability (NPT-ES)
Timeframe: Immediately after each session during the 4-week intervention period.