Clinical trial NCT06923358: Virtual Nature as a Health-promoting Intervention for Nursing Home Residents With Dementia
Official title: Virtual Nature as a Health-promoting Intervention for Nursing Home Residents With Dementia - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Nursing Home Resident
Virtual Reality
Quality of Life
Mental Health
Keywords: Virtual nature
Lead sponsor: University of South-Eastern Norway
Sponsor class: OTHER
Collaborators: name: Drammen municipality, Norway
First posted: 2025-04-11
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Rationale and Objectives:

Despite significant efforts from healthcare professionals, nursing home residents with dementia often face isolation and a reduced quality of life. Increasing attention has been given to digital solutions as a complement to pharmaceutical treatments. In particular, Virtual Nature (VN; i.e., virtual reality simulations that simulate nature experiences) has emerged as a promising, cost-effective approach to enhancing quality of life and slowing cognitive decline in nursing home residents with dementia. This project aims to assess the long-term effects of a VN intervention on various health and well-being indicators in nursing home residents with dementia.

Design:

The study will be conducted as a randomized controlled trial with parallel conditions. Participants will be randomly assigned to either a treatment or a control group. The treatment group will undergo a 12-week VN intervention in addition to usual medications and nursing home activities, while the control group will continue with their usual medications and activities. Assessments will be performed at baseline, in concomitance with the first VN session, and at 4 and 12 weeks into the intervention.

VN intervention:

The intervention will consist of undergoing a 10-minute VN session twice a week for 12 consecutive weeks. The participants will choose a 360° video from a library of different VN scenarios. The 360° videos within the library will be filmed by the researchers in locations near or in the same region of the participant's nursing homes, and will consist of scenes from various seasons in Norway (spring, summer, fall, winter) and depict popular outdoor recreations such as hiking and cross-country skiing. The VN sessions will be delivered in the participants' room. The playback will be done through a Meta Quest 3 (Reality Labs

, USA). The intervention will be delivered by the researchers in collaboration with caregivers and/or nursing students in practice.

Participants:

Sixty nursing home residents with dementia will be recruited from different nursing homes in Drammen municipality and randomly assigned to the treatment or the control condition. The treatment group will undergo the VN intervention while continuing to receive their usual medications and attending regular activities at their respective nursing homes. The control group will only continue receiving their usual medication and attending regular activities at their respective nursing homes. Inclusion criteria are: being a nursing-home resident with a dementia diagnosis, having normal or corrected-to-normal sight and being able to communicate in Norwegian. Additionally, participants will be excluded if deemed to have poor tolerance to the VN experience (this will be evaluated based on preliminary trials and discussions with caregivers). Written informed consent will be collected for all participants (either directly from the participant or, in case they are not legally competent, their caregivers), after having explained the benefits and risks of participating to them.

Instruments:

Basic demographic data (age and gender) will be recorded. To assess potential long-term effects, the following measures will be collected at baseline, week 4, and week 12 for both the treatment and control groups: Quality of Life in Late-stage Dementia scale, Cornell Scale for Depression in Dementia, Brief Agitation Rating Scale, Clinical Dementia Rating scale, and Use of psychotropic drugs.


Eligibility criteria: Inclusion Criteria:

* Nursing-home resident
* Dementia or pre-dementia

Exclusion Criteria:

* Sub-normal sight even when corrected
* Unable to communicate in Norwegian
* Reported or exhibited high intolerance to VN exposure

Primary outcomes:
measure: Quality of Life in Late-stage Dementia scale
timeFrame: Before the intervention (baseline)
measure: Quality of Life in Late-stage Dementia scale
timeFrame: During the intervention (4 weeks)
measure: Quality of Life in Late-stage Dementia scale
timeFrame: Immediately after the intervention (12 weeks)
Secondary outcomes:
measure: Cornell Scale for Depression in Dementia
timeFrame: Before the intervention (baseline)
measure: Cornell Scale for Depression in Dementia
timeFrame: During the intervention (4 weeks)
measure: Cornell Scale for Depression in Dementia
timeFrame: Immediately after the intervention (12 weeks)
measure: Brief Agitation Rating Scale
timeFrame: Before the intervention (baseline)
measure: Brief Agitation Rating Scale
timeFrame: During the intervention (4 weeks)
measure: Brief Agitation Rating Scale
timeFrame: Immediately after the intervention (12 weeks)
measure: Clinical Dementia Rating scale
timeFrame: Before the intervention (baseline)
measure: Clinical Dementia Rating scale
timeFrame: During the intervention (4 weeks)
measure: Clinical Dementia Rating scale
timeFrame: Immediately after the intervention (12 weeks)
measure: Use of psychotropic drugs
timeFrame: Before the intervention (baseline)
measure: Use of psychotropic drugs
timeFrame: During the intervention (4 weeks)
measure: Use of psychotropic drugs
timeFrame: Immediately after the intervention (12 weeks)
Other outcomes:
measure: Age
timeFrame: Before the intervention (baseline)
measure: Gender
timeFrame: Before the intervention (baseline)
Locations:
Study officials:
affiliation: University of South-Eastern Norway
name: Giovanna Calogiuri
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.
citation: Finkel SI, Lyons JS, Anderson RL. A brief agitation rating scale (BARS) for nursing home elderly. J Am Geriatr Soc. 1993 Jan;41(1):50-2. doi: 10.1111/j.1532-5415.1993.tb05948.x.
citation: Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.
citation: Roen I, Selbaek G, Kirkevold O, Engedal K, Lerdal A, Bergh S. The Reliability and Validity of the Norwegian Version of the Quality of Life in Late-Stage Dementia Scale. Dement Geriatr Cogn Disord. 2015;40(3-4):233-42. doi: 10.1159/000437093. Epub 2015 Jul 28.