Efficacy of the Voice-activated Intelligent Personal Assistant (VIPA) Intervention on Psychosocial Well-being Among People With Parkinson's Disease: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 13-item Sense of Coherence Scale
研究概览
简要总结
This pilot randomized control trial (RCT) aims to develop a Voice-activated Intelligent Personal Assistance (VIPA) user protocol and study its feasibility and preliminary efficacy among 60 People with Parkinson's disease (PWP). The research questions are:
Phase 1:
- What components should be included in the VIPA user protocol community-dwelling PWP?
- Is it feasible to implement the VIPA intervention in the PD population?
3 focus group interviews and 3 cognitive interviews will be held to formulate the VIPA user protocol. 5 healthcare and information technology experts will be invited to rate the relevancy of the formulated protocol and the item content validity index will be calculated by the researcher.
Phase 2:
- What is the preliminary efficacy of VIPA intervention on SOC and psychosocial well-being?
- Can such effect sustain for 4 weeks?
- What is the users' experience on the VIPA intervention?
60 participants will be randomized into the intervention group (IG) and control group (CG). During the 8-week intervention period, IG participants will receive the following materials:
- User protocol
- Designate VIPA
- 30-minute VIPA training on day 1
- Weekly technical support phone calls. CG participants will receive usual care, no intervention will be provided to CG participants, and they will continue their daily life during the intervention period.
The researcher will compare both groups to study the feasibility and preliminary efficacy of the VIPA on the participants' psychosocial well-being and sense of coherence.
详细描述
Background:
Parkinson's disease (PD) is one of the two most common neurodegenerative diseases affecting millions worldwide. PD research generally focuses on motor functioning and calls for more psychosocial interventions for people with Parkinson's disease (PWP).
The proposed VIPA intervention is an artificial intelligent personal assistant commonly used within Western society but not Asian countries, facilitating users' daily living by performing audio calls, messaging, and information searching. Recent literature showed VIPA Implementation is promising for rehabilitation in older adults but warrants more interventional studies to examine its efficacy and if it applies to other illnesses. Therefore, this study will formulate a positive health-orientated VIPA intervention protocol and investigate its efficacy in promoting PWP's sense of coherence and psychosocial well-being.
Objectives of the study:
This is a 2-phase study, and the objectives are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
outcome assessors will be blinded to the group allocation.
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
- •Cantonese-speaking Hong Kong permanent resident
- •Diagnosed with Parkinson's disease
- •Level 1-4 in the H&Y scale (Hoehn & Yahr, 1967)
- •Not currently using or owning VIPA
- •Has stable Wi-Fi connection at home.
排除标准
- •PWP or their caregivers that fails to provide valid consent
- •Individuals with hearing loss in both ears
- •Severe voice impairment
- •Dementia patients (MoCA score <21)
- •PWP will leave Hong Kong during the intervention period.
研究组 & 干预措施
Voice-activated Intelligent Personal Assistant (VIPA) intervention
IG participants will receive
- The developed VIPA user protocol
- 30-minute training session on day 1
- Weekly technical tele-support
Dosage of the intervention: PWP are encouraged to perform 10 voice commands/ day during the 8-week intervention period, self-reported usage will be documented by participants in a progress note.
干预措施: Voice-activated Intelligent Personal Assistant (VIPA) (Device)
Usual care, no intervention provided
CG participants will be placed under usual care, no intervention will be provided and PWP will continue their daily life during the intervention period
结局指标
主要结局
13-item Sense of Coherence Scale
时间窗: [Time Frame: Baseline; 8 weeks; 12 weeks]
The 13-item Sense of Coherence Scale is a 13 item, 7-point Likert scale that measures PWP's sense of coherence. Its score ranges from 13-91, with a higher score representing a higher sense of coherence.
次要结局
- Brief Resilient Coping Scale([Time Frame: Baseline; 8 weeks; 12 weeks])
- Montreal Cognitive Assessment (MoCA)([Time Frame: Screening; 8 weeks; 12 weeks])
- Self-report VIPA usage([Time Frame: 8 weeks])
- Mental Health Continuum Short Form([Time Frame: Baseline; 8 weeks; 12 weeks])
- Parkinson's Disease Questionnaire (PDQ-8)([Time Frame: Baseline; 8 weeks; 12 weeks])
- UCLA three-item loneliness scale([Time Frame: Baseline; 8 weeks; 12 weeks])
- EuroQol- 5 dimension- 5 level([Time Frame: Baseline])
- System Usability Scale([Time Frame: 8 weeks])
研究者
Dr Angela Leung
Professor
The Hong Kong Polytechnic University