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Parkinson's Disease and ParkinsonismNCT06036771

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

A study testing Voice-activated Intelligent Personal Assistant (VIPA) in people with Parkinson's Disease and Parkinsonism, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 48 People with Parkinson's disease (PWP). The research questions are: Phase 1: 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson's Disease and Parkinsonism
What is being tested?
Voice-activated Intelligent Personal Assistant (VIPA)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteHong Kong
Study dates
6 Aug 2023to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The Hong Kong Polytechnic University

    Kowloon, Hong Kong, 0000

Other trials in Hong Kong

About this study

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

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:

Read more
  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.

Read the 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: 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.

Being tested
Voice-activated Intelligent Personal Assistant (VIPA)
Keywords
sense of coherence, psychosocial well-being, Voice-activated Intelligence Personal assistant
Medical subject headings
Parkinson Disease, Parkinsonian Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Voice-activated Intelligent Personal Assistant (VIPA)Device

    Apple HomePod mini is selected as the intervention medium of this study as it is the only available smart speaker that supports Cantonese

Study groups in NCT06036771
Study groupRoleWhat they receive
Voice-activated Intelligent Personal Assistant (VIPA) interventionExperimentalIG 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.
Receives: Device: Voice-activated Intelligent Personal Assistant (VIPA)
Usual care, no intervention providedNo interventionCG participants will be placed under usual care, no intervention will be provided and PWP will continue their daily life during the intervention period

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 13-item Sense of Coherence Scale

    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.

    Measured: [Time Frame: Baseline; 8 weeks; 12 weeks]

Secondary outcomes (8)

  1. UCLA three-item loneliness scale

    The UCLA three-item loneliness scale is a 3 item, 3-point Likert scale that measures PWP's perceived loneliness. Its score ranges from 3-9, with a higher score indicating a more lonely sensation.

    Measured: [Time Frame: Baseline; 8 weeks; 12 weeks]

  2. Parkinson's Disease Questionnaire (PDQ-8)

    Parkinson's Disease Questionnaire (PDQ-8) is an 8 item, 5-point Likert scale commonly adopted to measure PWP's quality of life. The higher summative score indicates a lower quality of life experienced.

    Measured: [Time Frame: Baseline; 8 weeks; 12 weeks]

  3. EuroQol- 5 dimension- 5 level

    EuroQol- 5 dimension- 5 level utilized a visual analogue scale from 1-100 and 5 descriptive statements to explore an individual's quality of life. This scale is adopted to validate the newly translated PDQ-8

    Measured: [Time Frame: Baseline]

  4. Mental Health Continuum Short Form

    The Mental Health Continuum Short Form is a 14 item, 6-point Likert scale measuring PWP's psychosocial well-being. Its score ranges from 0-70, with a higher score indicating higher psychosocial well-being.

    Measured: [Time Frame: Baseline; 8 weeks; 12 weeks]

  5. Brief Resilient Coping Scale

    The Brief Resilient Coping Scale is a 4 item, 5-point Likert scale measuring an individual's coping. Its score ranges from 4-20, with a higher score indicating better coping.

    Measured: [Time Frame: Baseline; 8 weeks; 12 weeks]

  6. Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) is a professional administrated assessment to evaluate an individual's cognitive functioning. This scale will be first administered to screen out PWP with dementia. Its score ranges from 0-30, with a higher score representing higher cognitive functioning.

    Measured: [Time Frame: Screening]

  7. System Usability Scale

    System Usability Scale is a 10 item,5-point Likert scale that assess the usability of the implemented intervention. Its score ranges from 0-100, with a higher score indicates a higher usability

    Measured: [Time Frame: 8 weeks]

  8. Self-report VIPA usage

    PWP will report self-report VIPA usage across the intervention period. A logbook will be provided to PWP to log down their daily usage.

    Measured: [Time Frame: 8 weeks]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2023
  2. Study start6 Aug 2023
  3. Primary completion31 Mar 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
48 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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06036771
Sponsor's protocol ID
HSEARS20221107005
Status last verified
Sep 2023
First submitted
21 Aug 2023
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arnold A, Kolody S, Comeau A, Miguel Cruz A. What does the literature say about the use of personal voice assistants in older adults? A scoping review. Disabil Rehabil Assist Technol. 2024 Jan;19(1):100-111. doi: 10.1080/17483107.2022.2065369. Epub 2022 Apr 22.

    PubMed 35459429

  • Antonovsky, A. (1987). Unravelling the mystery of health: How people manage stress

  • Jenkinson, C., Fitzpatrick, R., Peto, V., Greenhall, R., & Hyman, N. (1997). The PDQ-8: development and validation of a short-form Parkinson's disease questionnaire. Psychology and Health, 12(6), 805-814.

  • Szende A, Janssen B, Cabases J, editors. Self-Reported Population Health: An International Perspective based on EQ-5D [Internet]. Dordrecht (NL): Springer; 2014. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK500356/

    PubMed 29787044

  • Keyes, C. L. (2018). Overview of The Mental Health Continuum Short Form (MHC-SF). doi: 10.13140/RG.2.2.24204.62088.

  • Brooke, J. (1996). SUS-A quick and dirty usability scale. Usability evaluation in industry, 189(194), 4-7.

  • Sinclair VG, Wallston KA. The development and psychometric evaluation of the Brief Resilient Coping Scale. Assessment. 2004 Mar;11(1):94-101. doi: 10.1177/1073191103258144.

    PubMed 14994958

  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PubMed 15817019

  • Subramanian I, Hinkle JT, Chaudhuri KR, Mari Z, Fernandez H, Pontone GM. Mind the gap: Inequalities in mental health care and lack of social support in Parkinson disease. Parkinsonism Relat Disord. 2021 Dec;93:97-102. doi: 10.1016/j.parkreldis.2021.11.015. Epub 2021 Nov 27.

    PubMed 34887173

  • Cools CI, de Vries NM, Bloem BR. Happiness: A Novel Outcome in Parkinson Studies? J Parkinsons Dis. 2020;10(3):1261-1266. doi: 10.3233/JPD-201999.

    PubMed 32568107

  • NIEHS(2021). Neurodegenerative Diseases. Retrieved from United States Department of Health and Human Services, The National Institute of Environmental Health Sciences (NIEHS) Web site: https://www.niehs.nih.gov/research/supported/health/neurodegenerative/index.cfm

Questions about this trial

What is this clinical trial studying?

A study testing Voice-activated Intelligent Personal Assistant (VIPA) in people with Parkinson's Disease and Parkinsonism, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

13-item Sense of Coherence Scale (time frame: [Time Frame: Baseline; 8 weeks; 12 weeks]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06036771, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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