Virtual Nature as a Health-promoting Intervention for Nursing Home Residents With Dementia - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quality of Life in Late-stage Dementia scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nursing-home resident
- •Dementia or pre-dementia
排除标准
- •Sub-normal sight even when corrected
- •Unable to communicate in Norwegian
- •Reported or exhibited high intolerance to VN exposure
研究组 & 干预措施
Virtual Nature intervention (VN)
A 12-week virtual nature (VN) intervention, alongside regular medications and nursing home activities.
干预措施: Virtual Nature intervention (VN) (Other)
Control (TAU)
Only the regular medications and nursing home activities ("treatment as usual")
结局指标
主要结局
Quality of Life in Late-stage Dementia scale
时间窗: 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.
Quality of Life in Late-stage Dementia scale
时间窗: 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.
Quality of Life in Late-stage Dementia scale
时间窗: 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.
次要结局
- Cornell Scale for Depression in Dementia(Before the intervention (baseline))
- Cornell Scale for Depression in Dementia(During the intervention (4 weeks))
- Brief Agitation Rating Scale(Before the intervention (baseline))
- Brief Agitation Rating Scale(During the intervention (4 weeks))
- Clinical Dementia Rating scale(Before the intervention (baseline))
- Clinical Dementia Rating scale(During the intervention (4 weeks))
- Use of psychotropic drugs(Before the intervention (baseline))
- Use of psychotropic drugs(During the intervention (4 weeks))
- Use of psychotropic drugs(Immediately after the intervention (12 weeks))
- Cornell Scale for Depression in Dementia(Immediately after the intervention (12 weeks))
- Brief Agitation Rating Scale(Immediately after the intervention (12 weeks))
- Clinical Dementia Rating scale(Immediately after the intervention (12 weeks))
研究者
Giovanna Calogiuri
Professor
University of South-Eastern Norway