NCT06036771

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 48 People with Parkinson's disease (PWP). The research questions are: Phase 1:

  1. 1.What components should be included in the VIPA user protocol community-dwelling PWP?
  2. 2.Is it feasible to implement the VIPA intervention in the PD population?
  3. 3.What is the preliminary efficacy of VIPA intervention on SOC and psychosocial well-being?
  4. 4.Can such effect sustain for 4 weeks?
  5. 5.What is the users' experience on the VIPA intervention?
  6. 6.User protocol
  7. 7.Designate VIPA
  8. 8.30-minute VIPA training on day 1
  9. 9.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

January 21, 2026

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

August 21, 2023

Last Update Submit

January 17, 2026

Conditions

Keywords

sense of coherencepsychosocial well-beingVoice-activated Intelligence Personal assistant

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (8)

  • UCLA three-item loneliness scale

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

  • Parkinson's Disease Questionnaire (PDQ-8)

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

  • EuroQol- 5 dimension- 5 level

    [Time Frame: Baseline]

  • Mental Health Continuum Short Form

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

  • Brief Resilient Coping Scale

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

  • +3 more secondary outcomes

Study Arms (2)

Voice-activated Intelligent Personal Assistant (VIPA) intervention

EXPERIMENTAL

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.

Device: Voice-activated Intelligent Personal Assistant (VIPA)

Usual care, no intervention provided

NO INTERVENTION

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

Interventions

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

Voice-activated Intelligent Personal Assistant (VIPA) intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, Hong Kong, 0000, Hong Kong

Location

Related Publications (11)

  • 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.

    PMID: 35459429BACKGROUND
  • Antonovsky, A. (1987). Unravelling the mystery of health: How people manage stress

    BACKGROUND
  • 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.

    BACKGROUND
  • 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/

    PMID: 29787044BACKGROUND
  • Lamers SM, Westerhof GJ, Bohlmeijer ET, ten Klooster PM, Keyes CL. Evaluating the psychometric properties of the Mental Health Continuum-Short Form (MHC-SF). J Clin Psychol. 2011 Jan;67(1):99-110. doi: 10.1002/jclp.20741.

    PMID: 20973032BACKGROUND
  • Brooke, J. (1996). SUS-A quick and dirty usability scale. Usability evaluation in industry, 189(194), 4-7.

    BACKGROUND
  • 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.

    PMID: 14994958BACKGROUND
  • 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.

    PMID: 15817019BACKGROUND
  • 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.

    PMID: 34887173BACKGROUND
  • 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.

    PMID: 32568107BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseParkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
outcome assessors will be blinded to the group allocation.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 21, 2023

First Posted

September 14, 2023

Study Start

August 6, 2023

Primary Completion

March 31, 2025

Study Completion

May 31, 2025

Last Updated

January 21, 2026

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations