- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06923358
Virtual Nature as a Health-promoting Intervention for Nursing Home Residents With Dementia (VR&Dementia)
Virtual Nature as a Health-promoting Intervention for Nursing Home Residents With Dementia - a Randomized Controlled Trial
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Drammen, Norway
- Sykehjem, bo- og servicesentre og serviceboliger
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Nature intervention (VN)
A 12-week virtual nature (VN) intervention, alongside regular medications and nursing home activities.
|
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.
|
|
No Intervention: Control (TAU)
Only the regular medications and nursing home activities ("treatment as usual")
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life in Late-stage Dementia scale
Time Frame: Before the intervention (baseline)
|
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
Time Frame: During the intervention (4 weeks)
|
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
Time Frame: Immediately after the intervention (12 weeks)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Use of psychotropic drugs
Time Frame: Before the intervention (baseline)
|
Use of psychotropic drugs, as reported by nursing staff, including medications for mood disorders, anxiety, depression, and sleep disturbances, are commonly prescribed to manage symptoms in dementia patients.
Nursing staff are asked to provide detailed information on the types, dosages, and frequency of psychotropic drugs administered to residents throughout the study period.
This measure will help evaluate potential changes in medication usage related to the virtual nature intervention, providing insight into its effects on behavioral and psychological symptoms of dementia.
|
Before the intervention (baseline)
|
|
Use of psychotropic drugs
Time Frame: During the intervention (4 weeks)
|
Use of psychotropic drugs, as reported by nursing staff, including medications for mood disorders, anxiety, depression, and sleep disturbances, are commonly prescribed to manage symptoms in dementia patients.
Nursing staff are asked to provide detailed information on the types, dosages, and frequency of psychotropic drugs administered to residents throughout the study period.
This measure will help evaluate potential changes in medication usage related to the virtual nature intervention, providing insight into its effects on behavioral and psychological symptoms of dementia.
|
During the intervention (4 weeks)
|
|
Use of psychotropic drugs
Time Frame: Immediately after the intervention (12 weeks)
|
Use of psychotropic drugs, as reported by nursing staff, including medications for mood disorders, anxiety, depression, and sleep disturbances, are commonly prescribed to manage symptoms in dementia patients.
Nursing staff are asked to provide detailed information on the types, dosages, and frequency of psychotropic drugs administered to residents throughout the study period.
This measure will help evaluate potential changes in medication usage related to the virtual nature intervention, providing insight into its effects on behavioral and psychological symptoms of dementia.
|
Immediately after the intervention (12 weeks)
|
|
Cornell Scale for Depression in Dementia
Time Frame: Before the intervention (baseline)
|
The Cornell Scale for Depression in Dementia (CSDD) is a clinician-administered assessment tool developed to evaluate depressive symptoms in individuals with dementia.
It combines information from direct interviews with the patient and observations reported by caregivers, allowing for the detection of mood-related symptoms that may not be reliably self-reported due to cognitive impairment.
The scale includes 19 items across domains such as mood, behavior, physical signs, and circadian functions.
Each item is rated on a 3-point scale (0 = absent, 1 = mild or intermittent, 2 = severe), resulting in a total score ranging from 0 to 38, where higher scores indicate more severe depressive symptoms.
The CSDD is commonly used in both clinical and research contexts to identify and monitor depression in individuals with dementia.
|
Before the intervention (baseline)
|
|
Cornell Scale for Depression in Dementia
Time Frame: During the intervention (4 weeks)
|
The Cornell Scale for Depression in Dementia (CSDD) is a clinician-administered assessment tool developed to evaluate depressive symptoms in individuals with dementia.
It combines information from direct interviews with the patient and observations reported by caregivers, allowing for the detection of mood-related symptoms that may not be reliably self-reported due to cognitive impairment.
The scale includes 19 items across domains such as mood, behavior, physical signs, and circadian functions.
Each item is rated on a 3-point scale (0 = absent, 1 = mild or intermittent, 2 = severe), resulting in a total score ranging from 0 to 38, where higher scores indicate more severe depressive symptoms.
The CSDD is commonly used in both clinical and research contexts to identify and monitor depression in individuals with dementia.
|
During the intervention (4 weeks)
|
|
Cornell Scale for Depression in Dementia
Time Frame: Immediately after the intervention (12 weeks)
|
The Cornell Scale for Depression in Dementia (CSDD) is a clinician-administered assessment tool developed to evaluate depressive symptoms in individuals with dementia.
It combines information from direct interviews with the patient and observations reported by caregivers, allowing for the detection of mood-related symptoms that may not be reliably self-reported due to cognitive impairment.
The scale includes 19 items across domains such as mood, behavior, physical signs, and circadian functions.
Each item is rated on a 3-point scale (0 = absent, 1 = mild or intermittent, 2 = severe), resulting in a total score ranging from 0 to 38, where higher scores indicate more severe depressive symptoms.
The CSDD is commonly used in both clinical and research contexts to identify and monitor depression in individuals with dementia.
|
Immediately after the intervention (12 weeks)
|
|
Brief Agitation Rating Scale
Time Frame: Before the intervention (baseline)
|
The Brief Agitation Rating Scale (BARS) is an observational assessment tool developed to measure the severity of agitation in individuals with cognitive impairments, including dementia.
The scale includes 10 items that evaluate behaviors such as restlessness, irritability, verbal aggression, and physical aggression.
Each item is rated on a 4-point scale (0 = not present, 1 = mild, 2 = moderate, 3 = severe), resulting in a total score ranging from 0 to 30, where higher scores indicate more severe agitation.
The BARS is designed to be brief and practical, enabling quick assessment by caregivers or clinicians in both clinical and research settings.
|
Before the intervention (baseline)
|
|
Brief Agitation Rating Scale
Time Frame: During the intervention (4 weeks)
|
The Brief Agitation Rating Scale (BARS) is an observational assessment tool developed to measure the severity of agitation in individuals with cognitive impairments, including dementia.
The scale includes 10 items that evaluate behaviors such as restlessness, irritability, verbal aggression, and physical aggression.
Each item is rated on a 4-point scale (0 = not present, 1 = mild, 2 = moderate, 3 = severe), resulting in a total score ranging from 0 to 30, where higher scores indicate more severe agitation.
The BARS is designed to be brief and practical, enabling quick assessment by caregivers or clinicians in both clinical and research settings.
|
During the intervention (4 weeks)
|
|
Brief Agitation Rating Scale
Time Frame: Immediately after the intervention (12 weeks)
|
The Brief Agitation Rating Scale (BARS) is an observational assessment tool developed to measure the severity of agitation in individuals with cognitive impairments, including dementia.
The scale includes 10 items that evaluate behaviors such as restlessness, irritability, verbal aggression, and physical aggression.
Each item is rated on a 4-point scale (0 = not present, 1 = mild, 2 = moderate, 3 = severe), resulting in a total score ranging from 0 to 30, where higher scores indicate more severe agitation.
The BARS is designed to be brief and practical, enabling quick assessment by caregivers or clinicians in both clinical and research settings.
|
Immediately after the intervention (12 weeks)
|
|
Clinical Dementia Rating scale
Time Frame: Before the intervention (baseline)
|
The Clinical Dementia Rating (CDR) scale is a widely used clinical tool for assessing the severity of dementia by evaluating both cognitive and functional decline.
It examines six domains: memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care.
Each domain is scored on a 5-point scale, ranging from "no impairment" to "severe impairment".
The total CDR score (0, 0.5, 1, 2, or 3) reflects the overall stage of dementia, where higher scores indicate more severe impairment.
|
Before the intervention (baseline)
|
|
Clinical Dementia Rating scale
Time Frame: During the intervention (4 weeks)
|
The Clinical Dementia Rating (CDR) scale is a widely used clinical tool for assessing the severity of dementia by evaluating both cognitive and functional decline.
It examines six domains: memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care.
Each domain is scored on a 5-point scale, ranging from "no impairment" to "severe impairment".
The total CDR score (0, 0.5, 1, 2, or 3) reflects the overall stage of dementia, where higher scores indicate more severe impairment.
|
During the intervention (4 weeks)
|
|
Clinical Dementia Rating scale
Time Frame: Immediately after the intervention (12 weeks)
|
The Clinical Dementia Rating (CDR) scale is a widely used clinical tool for assessing the severity of dementia by evaluating both cognitive and functional decline.
It examines six domains: memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care.
Each domain is scored on a 5-point scale, ranging from "no impairment" to "severe impairment".
The total CDR score (0, 0.5, 1, 2, or 3) reflects the overall stage of dementia, where higher scores indicate more severe impairment.
|
Immediately after the intervention (12 weeks)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age
Time Frame: Before the intervention (baseline)
|
Participant's age, as reported by the nursing-home staff
|
Before the intervention (baseline)
|
|
Gender
Time Frame: Before the intervention (baseline)
|
Participant's gender, as reported by the nursing-home staff
|
Before the intervention (baseline)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Giovanna Calogiuri, University of South-Eastern Norway
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 819127
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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