NCT06923358

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

March 6, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

September 8, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

March 6, 2025

Last Update Submit

April 21, 2026

Conditions

Keywords

Virtual nature

Outcome Measures

Primary Outcomes (3)

  • Quality of Life in Late-stage Dementia scale

    The Quality of Life in Late-Stage Dementia (QUALID) scale is an observational tool used to assess quality of life in individuals with advanced dementia. It consists of 11 items that evaluate various aspects of well-being, including physical comfort, social interaction, and emotional state. The scale is completed by caregivers or healthcare professionals based on their observations of the individual's behavior and condition. Each item is rated on a 5-point scale, resulting in a total score ranging from 11 to 55, where lower scores indicate better quality of life. The QUALID scale is widely used to assess the impact of interventions and care strategies, helping to ensure comfort and dignity in the final stages of life.

    Before the intervention (baseline)

  • Quality of Life in Late-stage Dementia scale

    The Quality of Life in Late-Stage Dementia (QUALID) scale is an observational tool used to assess quality of life in individuals with advanced dementia. It consists of 11 items that evaluate various aspects of well-being, including physical comfort, social interaction, and emotional state. The scale is completed by caregivers or healthcare professionals based on their observations of the individual's behavior and condition. Each item is rated on a 5-point scale, resulting in a total score ranging from 11 to 55, where lower scores indicate better quality of life. The QUALID scale is widely used to assess the impact of interventions and care strategies, helping to ensure comfort and dignity in the final stages of life.

    During the intervention (4 weeks)

  • Quality of Life in Late-stage Dementia scale

    The Quality of Life in Late-Stage Dementia (QUALID) scale is an observational tool used to assess quality of life in individuals with advanced dementia. It consists of 11 items that evaluate various aspects of well-being, including physical comfort, social interaction, and emotional state. The scale is completed by caregivers or healthcare professionals based on their observations of the individual's behavior and condition. Each item is rated on a 5-point scale, resulting in a total score ranging from 11 to 55, where lower scores indicate better quality of life. The QUALID scale is widely used to assess the impact of interventions and care strategies, helping to ensure comfort and dignity in the final stages of life.

    Immediately after the intervention (12 weeks)

Secondary Outcomes (12)

  • Cornell Scale for Depression in Dementia

    Before the intervention (baseline)

  • Cornell Scale for Depression in Dementia

    During the intervention (4 weeks)

  • Cornell Scale for Depression in Dementia

    Immediately after the intervention (12 weeks)

  • Brief Agitation Rating Scale

    Before the intervention (baseline)

  • Brief Agitation Rating Scale

    During the intervention (4 weeks)

  • +7 more secondary outcomes

Other Outcomes (2)

  • Age

    Before the intervention (baseline)

  • Gender

    Before the intervention (baseline)

Study Arms (2)

Virtual Nature intervention (VN)

EXPERIMENTAL

A 12-week virtual nature (VN) intervention, alongside regular medications and nursing home activities.

Other: Virtual Nature intervention (VN)

Control (TAU)

NO INTERVENTION

Only the regular medications and nursing home activities ("treatment as usual")

Interventions

The intervention will consist of a 12-week virtual nature program in which participants will engage in two sessions per week. During each session, they will watch a 10-minute 360° video depicting a natural setting. Participants will select videos from a curated library of nature scenarios filmed by researchers in locations near or within the same region as their nursing homes. The videos will showcase various seasons in Norway (spring, summer, fall, and winter) and include popular activities such as hiking and cross-country skiing. The videos will be played using a Meta Quest 3 headset, with sessions conducted in participants' rooms by nursing home staff-except for the first session, which will be facilitated by the researchers.

Virtual Nature intervention (VN)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nursing-home resident
  • Dementia or pre-dementia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sykehjem, bo- og servicesentre og serviceboliger

Drammen, Norway

Location

Related Publications (4)

  • 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.

    PMID: 8232972BACKGROUND
  • 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.

    PMID: 8418123BACKGROUND
  • 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.

    PMID: 3337862BACKGROUND
  • 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.

    PMID: 26227299BACKGROUND

Related Links

MeSH Terms

Conditions

DementiaPsychological Well-Being

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersPersonal SatisfactionBehavior

Study Officials

  • Giovanna Calogiuri

    University of South-Eastern Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2025

First Posted

April 11, 2025

Study Start

September 8, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations