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

Primary Purpose

Parkinson's Disease and Parkinsonism

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Voice-activated Intelligent Personal Assistant (VIPA)
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Parkinson's Disease and Parkinsonism focused on measuring sense of coherence, psychosocial well-being, Voice-activated Intelligence Personal assistant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Voice-activated Intelligent Personal Assistant (VIPA) intervention

Usual care, no intervention provided

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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.
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.
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.
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
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.

Full Information

First Posted
August 21, 2023
Last Updated
September 11, 2023
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT06036771
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.
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: To develop and validate the VIPA user protocol. To examine the feasibility of the VIPA intervention. Phase 2: To investigate the preliminary efficacy of the VIPA intervention on PWP's SOC 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease and Parkinsonism
Keywords
sense of coherence, psychosocial well-being, Voice-activated Intelligence Personal assistant

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
outcome assessors will be blinded to the group allocation.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Voice-activated Intelligent Personal Assistant (VIPA) intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care, no intervention provided
Arm Type
No Intervention
Arm 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
Intervention Type
Device
Intervention Name(s)
Voice-activated Intelligent Personal Assistant (VIPA)
Intervention Description
Apple HomePod mini is selected as the intervention medium of this study as it is the only available smart speaker that supports Cantonese
Primary Outcome Measure Information:
Title
13-item Sense of Coherence Scale
Description
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
[Time Frame: Baseline; 8 weeks; 12 weeks]
Secondary Outcome Measure Information:
Title
UCLA three-item loneliness scale
Description
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.
Time Frame
[Time Frame: Baseline; 8 weeks; 12 weeks]
Title
Parkinson's Disease Questionnaire (PDQ-8)
Description
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.
Time Frame
[Time Frame: Baseline; 8 weeks; 12 weeks]
Title
EuroQol- 5 dimension- 5 level
Description
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
Time Frame
[Time Frame: Baseline]
Title
Mental Health Continuum Short Form
Description
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.
Time Frame
[Time Frame: Baseline; 8 weeks; 12 weeks]
Title
Brief Resilient Coping Scale
Description
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.
Time Frame
[Time Frame: Baseline; 8 weeks; 12 weeks]
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
[Time Frame: Screening; 8 weeks; 12 weeks]
Title
System Usability Scale
Description
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
Time Frame
[Time Frame: 8 weeks]
Title
Self-report VIPA usage
Description
PWP will report self-report VIPA usage across the intervention period. A logbook will be provided to PWP to log down their daily usage.
Time Frame
[Time Frame: 8 weeks]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Leung, PhD
Phone
+852 2766 5587
Email
angela.ym.leung@polyu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Terence Lau, MSc
Phone
+852 3400 8297
Email
terence.lau@connect.polyu.hk
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Kowloon
ZIP/Postal Code
0000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Leung, PhD
Phone
+852 2766 5587
Email
angela.ym.leung@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
Terence Lau, MSc
Phone
+852 3400 8297
Email
terence.lau@connect.polyu.hk
First Name & Middle Initial & Last Name & Degree
Angela Leung, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35459429
Citation
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. 2022 Apr 22:1-12. doi: 10.1080/17483107.2022.2065369. Online ahead of print.
Results Reference
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Citation
Antonovsky, A. (1987). Unravelling the mystery of health: How people manage stress
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
29787044
Citation
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/
Results Reference
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Citation
Keyes, C. L. (2018). Overview of The Mental Health Continuum Short Form (MHC-SF). doi: 10.13140/RG.2.2.24204.62088.
Results Reference
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Citation
Brooke, J. (1996). SUS-A quick and dirty usability scale. Usability evaluation in industry, 189(194), 4-7.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
15817019
Citation
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. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
Results Reference
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PubMed Identifier
34887173
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Citation
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
Results Reference
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Voice-activated Intelligent Personal Assistant (VIPA) Intervention for People With Parkinson's Disease

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