Voice-activated Intelligent Personal Assistant (VIPA) Intervention for People With Parkinson's Disease

The Hong Kong Polytechnic University

Status: Completed

Conditions: Parkinson's Disease and Parkinsonism

Treatments: Device: Voice-activated Intelligent Personal Assistant (VIPA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06036771

HSEARS20221107005

Details and patient eligibility

About

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 48 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?

48 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. technical support hotline. 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.

Full 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: 48 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 technical support hotline. 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Voice-activated Intelligent Personal Assistant (VIPA) intervention

Experimental group

Description:

IG participants will receive 1. The developed VIPA user protocol 2. 30-minute training session on day 1 3. Technical support hotline 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.

Treatment:

Device: Voice-activated Intelligent Personal Assistant (VIPA)

Usual care, no intervention provided

No Intervention group

Description:

CG participants will be placed under usual care, no intervention will be provided and PWP will continue their daily life during the intervention period