Clinical trial NCT06036771: Voice-activated Intelligent Personal Assistant (VIPA) Intervention for People With Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease and Parkinsonism
Keywords: sense of coherence
psychosocial well-being
Voice-activated Intelligence Personal assistant
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 60 PWP will be randomized into the intervention group (IG) and controlled group (CG). Block randomization is performed by an independent research team member who will not be in contact with participants via a free third-party website. Allocations will only be revealed upon the commencement of the intervention period and cannot be altered.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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:

1. What components should be included in the VIPA user protocol community-dwelling PWP?
2. 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:

1. What is the preliminary efficacy of VIPA intervention on SOC and psychosocial well-being?
2. Can such effect sustain for 4 weeks?
3. 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:

1. User protocol
2. Designate VIPA
3. 30-minute VIPA training on day 1
4. 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.

Detailed description: 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:

Phase 1:

1. To develop and validate the VIPA user protocol.
2. To examine the feasibility of the VIPA intervention.

Phase 2:

1. To investigate the preliminary efficacy of the VIPA intervention on PWP's SOC
2. To explore the users' experience of VIPA intervention among PWP.

Method:

Phase 1: 3 semi-structured focus group interviews will be held to generate items in user protocol. Another 3 cognitive interviews will be held with PWP to test the face validity and feasibility of the user protocol. 5 healthcare and information technology experts will then be invited to assess the content validity of the protocol. Any item with an item content validity index (i-CVI) score lower than 0.78 will be discarded or revised.

Phase 2: 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 user protocol, a designated VIPA, a 30-minute VIPA training on day 1, and 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 13-item Sense of Coherence Scale (SOC-13) will be set as the primary outcome, and secondary outcomes are: 1. University of California, Los Angeles (UCLA) three-item loneliness scale; 2. Parkinson's Disease Questionnaire (PDQ-8); 3. EuroQol-5 dimension-5 level; 4. Mental Health Continuum Short Form; 5. System Usability Scale; 6. Brief Resilient Coping Scale; 7. Montreal Cognitive Assessment; and 8. Self-report VIPA usage.

12 participants will then be selected through extreme case sampling to partake in explanatory, in-depth interviews based on their SOC-13 score differences between baseline and post-intervention tests to explore VIPA user experience.

Data analysis:

For qualitative data, content analysis will be used in phase 1, while in phase 2, in-depth interview data will be analyzed through deductive thematic analysis according to the salutogenic model. Quantitative data, such as demographic data, will be presented with descriptive statistics. Chi-square test and independent t-test will be performed for baseline comparison. Generalized Estimating Equations will be used to analyze group differences in all primary and secondary outcomes.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 13-item Sense of Coherence Scale
timeFrame: [Time Frame: Baseline; 8 weeks; 12 weeks]
Secondary outcomes:
measure: UCLA three-item loneliness scale
timeFrame: [Time Frame: Baseline; 8 weeks; 12 weeks]
measure: Parkinson's Disease Questionnaire (PDQ-8)
timeFrame: [Time Frame: Baseline; 8 weeks; 12 weeks]
measure: EuroQol- 5 dimension- 5 level
timeFrame: [Time Frame: Baseline]
measure: Mental Health Continuum Short Form
timeFrame: [Time Frame: Baseline; 8 weeks; 12 weeks]
measure: Brief Resilient Coping Scale
timeFrame: [Time Frame: Baseline; 8 weeks; 12 weeks]
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: [Time Frame: Screening; 8 weeks; 12 weeks]
measure: System Usability Scale
timeFrame: [Time Frame: 8 weeks]
measure: Self-report VIPA usage
timeFrame: [Time Frame: 8 weeks]
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References:
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