Personalized Virtual Environments for Patients with Cognitive Impairment Exhibiting Responsive Behaviors: Proof-of-Concept and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility based on the health staff operator perspective using the System Usability Scale (SUS)
研究概览
简要总结
The goal of this feasibility study is to explore the feasibility of using realistic, customizable virtual reality (VR) environments in response to the onset of Responsive Behaviors in elderly residents with cognitive impairment.
Specifically, the study will assess;
- feasibility through acceptance metrics (including recruitment rate, adherence rate, attrition rate, and tolerance to the intervention);
- safety (monitoring for adverse effects related to VR headset use);
- user engagement, enjoyment, and overall experience.
Participants will be exposed to three VR sessions conducted before, during, or after a situation deemed activating (e.g., personal hygiene activities). Operators will conduct a baseline assessment to identify specific moments when the participant experiences responsive behaviors. Additionally, operators may administer the Oculus VR headset when responsive behaviors occur outside of baseline-identified moments.
详细描述
Study Site and Environment: Data collection will occur at the Azienda Pubblica di Servizi alla Persona "Margherita Grazioli" in Povo, Trento. The experimental setup will be free from external interference to minimize distractions and ensure a smooth study process. The study will be conducted in familiar, ecologically relevant settings within APSP, selecting environments likely to stimulate activation states in participants.
Duration and Procedure: The study is expected to last six months. Each participant will undergo at least three VR sessions about situations that may trigger activation, such as personal hygiene activities. A baseline assessment will pinpoint specific times when participants exhibit responsive behaviors. Additionally, VR sessions may be initiated if responsive behaviors arise outside the predicted times using the Oculus headset.
Procedure and Timing for Each VR Session:
Preliminary Assessment (Participant Selection) (~30 minutes):
Participants are selected based on inclusion/exclusion criteria and provided with informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 18 years of age.
- •Native Italian speakers.
- •Can provide written informed consent for study participation or have a legal guardian who can give consent on their behalf.
排除标准
- •Presence of any psychiatric diagnoses as recorded in medical records.
- •A total score of ≥ 40 on the Neuropsychiatric Inventory (NPI) indicates neuropsychiatric symptoms.
- •A partial NPI score > 6 in the domains of agitation/aggression or delusions.
- •Enrollment in palliative care services.
- •Severe neurological damage, a positive diagnosis of epilepsy, or having first-degree relatives diagnosed with epilepsy.
- •Presence of a cardiac pacemaker or other metallic devices.
- •Infectious or gastrointestinal disorders.
- •Open facial wounds, motor or visual impairments, or neuromuscular pain that would prevent using the Oculus VR headset.
- •Refusal to consent, either by the individual or their legal representative, for study participation.
结局指标
主要结局
Feasibility based on the health staff operator perspective using the System Usability Scale (SUS)
时间窗: From enrollment to the end of treatment at 3 weeks
The SUS scale permitted the obtaining of information about the system's usability. The SUS range raw score from 0 to 100.
Feasibility using an Ad-hoc questionnaire
时间窗: From enrollment to the end of treatment at 3 weeks
The ad-hoc questionnaire permitted information about usability, engagement, satisfaction, and pleasure during exposure to the VR environment, as well as feelings and relaxation. The questionnaire is composed of 30 items based on a Likert scale from 1 to 5 (range score from 0 to 4), 15 items based on a Likert scale from 1 to 4 (range score from 0 to 3), and five open-ended questions.
Feasibility using the Non-pharmacological Therapy Experience Scale (NPT-ES)
时间窗: From enrollment to the end of treatment at 3 weeks
The NPT-ES permitted obtaining information about the subjective experience during the administration of non-pharmacological therapy. Five items are assessed on a Likert scale from 0 to 3. The total raw score is from 0 to 15.
Feasibility based on the health staff operator perspective using Focus Groups
时间窗: From enrollment to the end of treatment at 3 weeks
次要结局
- Assessment of the Responsive Behaviors administering the COHEN MANSFIELD - AGITATION INVENTORY (CMAI)(From enrollment to the end of treatment at 3 weeks)
- Assessment of the Responsive Behaviors administering the Functional Assessment Staging Tool (FAST)(From enrollment to the end of treatment at 3 weeks)
- Investigation of Adverse Symptoms Associated with Exposure to the Virtual Reality Device using the Virtual Reality Symptoms Questionnaire (VRSQ)(From enrollment to the end of treatment at 3 weeks)
- Assessment of the pharmacotherapy administration and the users'behaviors before or during the VR sessions using the DataSheet 2(From enrollment to the end of treatment at 3 weeks)
- Pain experience assessment using the Pain Assessment in Advanced Dementia (PAINAD)(From enrollment to the end of treatment at 3 weeks)
- Assessment of the state-anxiety using the State-Trait Anxiety Inventory-Y1 (STAI-Y1)(From enrollment to the end of treatment at 3 weeks)
- Emotional and behavioral assessment using the Observed Emotion Rating Scale (OERS)(From enrollment to the end of treatment at 3 weeks)
研究者
Susanna Pardini
Researcher
Fondazione Bruno Kessler