Immersive Virtual Reality for Older Adults in Long-Term Care Settings (VR-LTC)
Use of Immersive Virtual Reality in Long-Term Care Facilities and Seniors' Homes in Quebec
The goal of this clinical trial is to learn if an immersive virtual reality mindfulness meditation program is feasible and acceptable for older adults living in long-term care settings in Quebec who have mild to moderate neurocognitive disorder. It will also learn about the safety and potential effects of the program on well-being.
The main questions it aims to answer are:
- Is the virtual reality mindfulness meditation program feasible and acceptable for residents and staff in long-term care settings?
- Does the adapted version of the program show potential benefits for well-being, including depression, anxiety, quality of life, mindfulness, pain, and loneliness?
- What practical challenges, user experiences, and side effects, such as cybersickness, occur during the program?
Researchers will compare the original Toujours Dimanche virtual reality mindfulness meditation program, an adapted version of Toujours Dimanche designed for older adults with mild to moderate neurocognitive disorder, and standard care alone to see if the adapted program is feasible, acceptable, and potentially helpful.
Participants will:
- Take part in up to 8 virtual reality mindfulness meditation sessions over 4 weeks, if assigned to a virtual reality group
- Complete questionnaires before and after the 4-week study period
- Share feedback about their experience, when possible
- Be observed by staff or research team members to document feasibility, acceptability, user experience, and safety
研究概览
地位
条件
详细说明
This pilot feasibility trial will evaluate the use of a mindfulness meditation intervention delivered with or without the Toujours Dimanche immersive virtual reality application in long-term care settings in Quebec. The study will be conducted with older adults living in long-term care facilities, seniors' homes, and alternative seniors' homes in the Chaudière-Appalaches and Capitale-Nationale regions who have mild to moderate cognitive impairment or neurocognitive disorder.
The pilot phase will use a randomized experimental design. The purpose of this phase is to evaluate the feasibility, acceptability, safety, user experience, and preliminary effects of the intervention in real-world long-term care settings. This phase will also help identify practical issues related to time management, human resources, data collection, and intervention delivery before a future larger-scale effectiveness trial.
A total of 36 residents will be recruited. This sample size is based on recommendations for feasibility studies, with 12 participants per group. Staff members who regularly work with participating residents and who have completed virtual reality training through Super Splendide and/or Martine Bordeleau will also be recruited. These staff members will deliver the intervention and provide feedback on its feasibility and acceptability.
Residents who meet the inclusion and exclusion criteria will be assigned to one of three groups. Group A will receive standard care and guided mindfulness meditation sessions designed for people with cognitive impairment. Group B will receive standard care and the adapted version of the Toujours Dimanche program, which includes guided mindfulness meditation sessions designed for people with cognitive impairment. Group C will receive standard care for four weeks.
Allocation to the groups will be performed using minimization, a method recognized as an acceptable alternative to randomization when the sample size is small. The allocation procedure will consider sex, gender, and age group. The study coordinator will have access to participants' group allocation. The long-term care team will plan the intervention sessions and inform the study coordinator of the selected dates and times.
Participants in Groups A and B will be invited to complete 8 mindfulness meditation sessions over 4 consecutive weeks, with approximately 2 sessions per week. Each session will last about 5 to 15 minutes, depending on the participant's preferences, comfort, and tolerance. The sessions will be delivered by trained staff members who know the participating residents well. Sessions will take place in the resident's room. Participants may stop a session at any time.
Data will be collected from residents and staff members when possible. If a resident has difficulty communicating verbally or through gestures, the staff member who knows the resident best may provide responses using observer-rated versions of the questionnaires. Sociodemographic information will be collected at baseline. Feedback on the program will be collected after the 4-week study period from residents, when possible, and from staff members.
Feasibility outcomes will include recruitment, adherence, attrition, intervention completion, and practical challenges encountered during implementation. Acceptability will be assessed from the perspectives of residents and staff using researcher-developed questions, including visual analogue scales and open-ended questions. User experience, perceived presence, potential risks, side effects, and other practical issues will also be documented.
Preliminary clinical outcomes will be assessed before the beginning of the intervention and after the end of the 4-week period. The primary clinical outcomes are depression and anxiety. Quality of life will be assessed as a secondary outcome. Mindfulness, pain, and loneliness will be assessed as tertiary or exploratory outcomes. Measures will be administered in a predefined order, beginning with depression and anxiety, followed by quality of life, and then the exploratory outcomes. If a participant shows signs of excessive fatigue or reduced motivation, data collection may be paused or stopped.
Because the study includes residents with cognitive impairment, consent and assent procedures will be adapted to protect residents' rights, comfort, and dignity. When residents are able to provide informed consent, consent will be obtained directly from them. When needed, consent will be obtained from a legal representative or from a person authorized to consent on behalf of the resident. Resident assent will also be sought verbally or behaviorally before participation. Before each visit, residents will be asked whether they are still interested in participating. If a resident refuses, shows distress, or no longer wishes to participate, study activities will stop.
The purpose of this pilot trial is not to determine definitive effectiveness. Rather, it will assess whether the intervention and study procedures are feasible, acceptable, and safe for older adults with mild to moderate cognitive impairment or neurocognitive disorder living in long-term care settings.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Martine Bordeleau, PhD
- 电话号码：581-490-2626
- 邮箱：martine.bordeleau@outlook.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
For resident participants:
- Resident of a participating long-term care facility, seniors' home, or alternative seniors' home in the Chaudière-Appalaches or Capitale-Nationale regions of Quebec
- Aged 60 years or older
- Able to understand French or English
- Able to provide informed consent or assent, or have consent provided by a legally authorized representative or person authorized to consent
- Mild to moderate cognitive impairment or neurocognitive disorder
- Normal or corrected vision and hearing
For staff participants:
- Regularly works with at least one resident participating in Phase 3
- Has completed the revised virtual reality training provided by Super Splendide and/or Martine Bordeleau
Exclusion Criteria:
For resident participants:
- Recurrent migraines
- Epilepsy
- Traumatic brain injury during the past year
- Glaucoma or recovery from eye surgery
- Diagnosed uncontrolled epilepsy
- Diagnosed severe vertigo
- Severe hearing impairment without a corrective hearing device
- Significant visual impairment that would prevent use of a virtual reality headset
- Motion sickness that would prevent use of a virtual reality headset
- Any health condition that restricts movement or prevents safe participation, such as a significant reduction in neck or upper-limb range of motion
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Guided Mindfulness Meditation
Participants in this group will receive standard care and guided mindfulness meditation sessions designed for people with cognitive impairment.
Participants will be invited to complete 8 sessions over 4 consecutive weeks, with approximately 2 sessions per week.
Each session will last about 5 to 15 minutes, depending on participant preferences, comfort, and tolerance.
|
Mindfulness Meditation for Cognitive Impairment
Standard Care
|
|
实验性的：Adapted Toujours Dimanche Virtual Reality Meditation
Participants in this group will receive standard care and the adapted Toujours Dimanche immersive virtual reality program.
The intervention includes guided mindfulness meditation sessions designed for older adults with mild to moderate cognitive impairment or neurocognitive disorder.
Participants will be invited to complete 8 sessions over 4 consecutive weeks, with approximately 2 sessions per week.
Each session will last about 5 to 15 minutes.
|
Standard Care
Immersive Virtual Reality Mindfulness Meditation
|
|
有源比较器：Standard Care
Participants in this group will receive standard care alone for 4 weeks.
They will not receive the guided mindfulness meditation intervention or the Toujours Dimanche virtual reality meditation program during the study period.
|
Standard Care
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recruitment, Retention, Adherence, Blinding, and Safety Feasibility Indicators
大体时间：Up to 4 weeks
|
Feasibility will be assessed descriptively using feasibility indicators recommended by Thabane et al. for pilot studies.
These indicators will include recruitment feasibility, assessed by the recruitment rate; intervention completion, assessed through adherence to planned sessions and attrition/retention rates; blinding feasibility, assessed through the effectiveness of blinding procedures; potential risks, assessed through the number, type, frequency, and severity of adverse events; and practical implementation challenges requiring modification of the intervention or study procedures.
Reference: Thabane L, Ma J, Chu R, et al.
A tutorial on pilot studies: the what, why and how.
BMC Medical Research Methodology.
2010;10(1):1-10.
|
Up to 4 weeks
|
|
Acceptability of the Intervention
大体时间：At 4 weeks
|
Acceptability will be assessed from the perspectives of residents and staff using a researcher-developed acceptability questionnaire designed specifically for this study.
The questionnaire includes 1-to-7 visual analogue scales and open-ended questions about the virtual reality mindfulness meditation program.
For the 1-to-7 scales, the minimum value is 1 and the maximum value is 7, with higher scores indicating greater acceptability of the intervention.
Open-ended responses will be summarized descriptively to document participants' and staff members' perceptions, comments, and suggestions.
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At 4 weeks
|
|
Change in Depression Symptoms
大体时间：Baseline and 4 weeks
|
Depression symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), completed by the resident when possible and/or by a staff member using an observer-rated version.
Total scores range from 0 to 27.
Higher scores indicate greater depression symptom severity.
|
Baseline and 4 weeks
|
|
Change in Anxiety Symptoms
大体时间：Baseline and 4 weeks
|
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 item scale (GAD-7), completed by the resident when possible and/or by a staff member using an observer-rated version.
Total scores range from 0 to 21.
Higher scores indicate greater anxiety symptom severit
|
Baseline and 4 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Quality of Life
大体时间：Baseline and 4 weeks
|
Quality of life will be assessed using the Quality of Life in Alzheimer's Disease Scale Nursing Home version (QoL-AD-NH), completed by the resident when possible and/or by a caregiver proxy.
The QoL-AD-NH includes 13 items assessing key life domains, such as physical health, mood, memory, relationships, and finances.
Each item is scored on a 4-point scale: 1 = poor, 2 = fair, 3 = good, and 4 = excellent.
Total scores range from 13 to 52, with higher scores indicating better quality of life.
Scores from 40 to 52 indicate high quality of life, scores from 27 to 39 indicate moderate quality of life, and scores from 13 to 26 indicate low quality of life.
|
Baseline and 4 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Self-Reported Pain Intensity
大体时间：Baseline and 4 weeks
|
Self-reported pain intensity will be assessed using the Numeric Rating Scale (NRS), completed by the resident when possible.
Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Higher scores indicate greater pain intensity.
|
Baseline and 4 weeks
|
|
Change in Observed Pain
大体时间：Baseline and 4 weeks
|
Observed pain will be assessed using the Pain Assessment in Advanced Dementia Scale (PAIN-AD), completed by a staff member.
The PAIN-AD includes 5 observed behavioral indicators, each scored from 0 to 2. Total scores range from 0 to 10, with higher scores indicating more pain-related behaviors.
A score of 0 indicates no observed pain-related behavior; scores from 1 to 3 may indicate mild pain; scores from 4 to 6 may indicate moderate pain; and scores from 7 to 10 may indicate severe pain.
|
Baseline and 4 weeks
|
|
Change in Loneliness
大体时间：Baseline and 4 weeks
|
Loneliness will be assessed using the UCLA Loneliness Scale short form (ULS-6), completed by the resident when possible.
The ULS-6 includes 6 items.
Total scores range from 6 to 24, with higher scores indicating greater loneliness.
|
Baseline and 4 weeks
|
|
Change in Social Engagement
大体时间：Baseline and 4 weeks
|
Social engagement will be assessed using the Engagement of a Person with Dementia Scale (EPWDS), completed by a staff member.
The EPWDS includes 10 items assessing affective, visual, verbal, behavioral, and social engagement.
Each item is scored on a 1-to-5 scale, with some items reverse scored.
Total scores range from 10 to 50.
Higher scores indicate greater positive engagement, while lower scores indicate greater disengagement or negative engagement.
|
Baseline and 4 weeks
|
|
Change in Daily Mindful Responding
大体时间：Baseline and 4 weeks
|
Daily mindful responding will be assessed using the Daily Mindful Responding Scale (DMRS), completed by the resident when possible.
The DMRS is a 4-item scale designed to assess mindful responding in daily life.
Items are rated on a 1-to-10 scale, and item scores are averaged to compute the total score.
Total scores range from 1 to 10. Higher scores indicate greater mindful responding in daily life.
|
Baseline and 4 weeks
|
|
Change in Observed Mindfulness
大体时间：Baseline and 4 weeks
|
Observed mindfulness will be assessed using the Observed Mindfulness Measure (OMM), completed by a staff member who knows the resident.
The OMM is a 9-item observer-rated questionnaire assessing mindful behaviors, including awareness, acceptance, and attentiveness.
Total scores range from 9 to 45. Higher scores indicate greater observed mindful behavior.
|
Baseline and 4 weeks
|
合作者和调查者
调查人员
- 首席研究员：Maude Laberge, PhD、Laval University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Guided Mindfulness Meditation的临床试验
-
The Second Hospital of Shandong University完全的