xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06036771</url>
    </required_header>
    <id_info>
      <org_study_id>HSEARS20221107005</org_study_id>
      <nct_id>NCT06036771</nct_id>
    </id_info>
    <brief_title>Voice-activated Intelligent Personal Assistant (VIPA) Intervention for People With Parkinson's Disease</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Hong Kong Polytechnic University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Hong Kong Polytechnic University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This pilot randomized control trial (RCT) aims to develop a Voice-activated Intelligent&#xD;
        Personal Assistance (VIPA) user protocol and study its feasibility and preliminary efficacy&#xD;
        among 60 People with Parkinson's disease (PWP). The research questions are:&#xD;
  &#xD;
        Phase 1:&#xD;
  &#xD;
          1. What components should be included in the VIPA user protocol community-dwelling PWP?&#xD;
  &#xD;
          2. Is it feasible to implement the VIPA intervention in the PD population?&#xD;
  &#xD;
        3 focus group interviews and 3 cognitive interviews will be held to formulate the VIPA user&#xD;
        protocol. 5 healthcare and information technology experts will be invited to rate the&#xD;
        relevancy of the formulated protocol and the item content validity index will be calculated&#xD;
        by the researcher.&#xD;
  &#xD;
        Phase 2:&#xD;
  &#xD;
          1. What is the preliminary efficacy of VIPA intervention on SOC and psychosocial&#xD;
             well-being?&#xD;
  &#xD;
          2. Can such effect sustain for 4 weeks?&#xD;
  &#xD;
          3. What is the users' experience on the VIPA intervention?&#xD;
  &#xD;
        60 participants will be randomized into the intervention group (IG) and control group (CG).&#xD;
        During the 8-week intervention period, IG participants will receive the following materials:&#xD;
  &#xD;
          1. User protocol&#xD;
  &#xD;
          2. Designate VIPA&#xD;
  &#xD;
          3. 30-minute VIPA training on day 1&#xD;
  &#xD;
          4. Weekly technical support phone calls. CG participants will receive usual care, no&#xD;
             intervention will be provided to CG participants, and they will continue their daily&#xD;
             life during the intervention period.&#xD;
  &#xD;
        The researcher will compare both groups to study the feasibility and preliminary efficacy of&#xD;
        the VIPA on the participants' psychosocial well-being and sense of coherence.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background:&#xD;
  &#xD;
        Parkinson's disease (PD) is one of the two most common neurodegenerative diseases affecting&#xD;
        millions worldwide. PD research generally focuses on motor functioning and calls for more&#xD;
        psychosocial interventions for people with Parkinson's disease (PWP).&#xD;
  &#xD;
        The proposed VIPA intervention is an artificial intelligent personal assistant commonly used&#xD;
        within Western society but not Asian countries, facilitating users' daily living by&#xD;
        performing audio calls, messaging, and information searching. Recent literature showed VIPA&#xD;
        Implementation is promising for rehabilitation in older adults but warrants more&#xD;
        interventional studies to examine its efficacy and if it applies to other illnesses.&#xD;
        Therefore, this study will formulate a positive health-orientated VIPA intervention protocol&#xD;
        and investigate its efficacy in promoting PWP's sense of coherence and psychosocial&#xD;
        well-being.&#xD;
  &#xD;
        Objectives of the study:&#xD;
  &#xD;
        This is a 2-phase study, and the objectives are:&#xD;
  &#xD;
        Phase 1:&#xD;
  &#xD;
          1. To develop and validate the VIPA user protocol.&#xD;
  &#xD;
          2. To examine the feasibility of the VIPA intervention.&#xD;
  &#xD;
        Phase 2:&#xD;
  &#xD;
          1. To investigate the preliminary efficacy of the VIPA intervention on PWP's SOC&#xD;
  &#xD;
          2. To explore the users' experience of VIPA intervention among PWP.&#xD;
  &#xD;
        Method:&#xD;
  &#xD;
        Phase 1: 3 semi-structured focus group interviews will be held to generate items in user&#xD;
        protocol. Another 3 cognitive interviews will be held with PWP to test the face validity and&#xD;
        feasibility of the user protocol. 5 healthcare and information technology experts will then&#xD;
        be invited to assess the content validity of the protocol. Any item with an item content&#xD;
        validity index (i-CVI) score lower than 0.78 will be discarded or revised.&#xD;
  &#xD;
        Phase 2: 60 participants will be randomized into the intervention group (IG) and control&#xD;
        group (CG). During the 8-week intervention period, IG participants will receive the user&#xD;
        protocol, a designated VIPA, a 30-minute VIPA training on day 1, and weekly technical support&#xD;
        phone calls. CG participants will receive usual care (no intervention will be provided to CG&#xD;
        participants), and they will continue their daily life during the intervention period. The&#xD;
        13-item Sense of Coherence Scale (SOC-13) will be set as the primary outcome, and secondary&#xD;
        outcomes are: 1. University of California, Los Angeles (UCLA) three-item loneliness scale; 2.&#xD;
        Parkinson's Disease Questionnaire (PDQ-8); 3. EuroQol-5 dimension-5 level; 4. Mental Health&#xD;
        Continuum Short Form; 5. System Usability Scale; 6. Brief Resilient Coping Scale; 7. Montreal&#xD;
        Cognitive Assessment; and 8. Self-report VIPA usage.&#xD;
  &#xD;
        12 participants will then be selected through extreme case sampling to partake in&#xD;
        explanatory, in-depth interviews based on their SOC-13 score differences between baseline and&#xD;
        post-intervention tests to explore VIPA user experience.&#xD;
  &#xD;
        Data analysis:&#xD;
  &#xD;
        For qualitative data, content analysis will be used in phase 1, while in phase 2, in-depth&#xD;
        interview data will be analyzed through deductive thematic analysis according to the&#xD;
        salutogenic model. Quantitative data, such as demographic data, will be presented with&#xD;
        descriptive statistics. Chi-square test and independent t-test will be performed for baseline&#xD;
        comparison. Generalized Estimating Equations will be used to analyze group differences in all&#xD;
        primary and secondary outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 6, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>outcome assessors will be blinded to the group allocation.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>13-item Sense of Coherence Scale</measure>
      <time_frame>[Time Frame: Baseline; 8 weeks; 12 weeks]</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>UCLA three-item loneliness scale</measure>
      <time_frame>[Time Frame: Baseline; 8 weeks; 12 weeks]</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parkinson's Disease Questionnaire (PDQ-8)</measure>
      <time_frame>[Time Frame: Baseline; 8 weeks; 12 weeks]</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EuroQol- 5 dimension- 5 level</measure>
      <time_frame>[Time Frame: Baseline]</time_frame>
      <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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mental Health Continuum Short Form</measure>
      <time_frame>[Time Frame: Baseline; 8 weeks; 12 weeks]</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brief Resilient Coping Scale</measure>
      <time_frame>[Time Frame: Baseline; 8 weeks; 12 weeks]</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montreal Cognitive Assessment (MoCA)</measure>
      <time_frame>[Time Frame: Screening; 8 weeks; 12 weeks]</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>System Usability Scale</measure>
      <time_frame>[Time Frame: 8 weeks]</time_frame>
      <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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-report VIPA usage</measure>
      <time_frame>[Time Frame: 8 weeks]</time_frame>
      <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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Parkinson's Disease and Parkinsonism</condition>
    <arm_group>
      <arm_group_label>Voice-activated Intelligent Personal Assistant (VIPA) intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>IG participants will receive&#xD;
  The developed VIPA user protocol&#xD;
  30-minute training session on day 1&#xD;
  Weekly technical tele-support&#xD;
  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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual care, no intervention provided</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <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</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Voice-activated Intelligent Personal Assistant (VIPA)</intervention_name>
      <description>Apple HomePod mini is selected as the intervention medium of this study as it is the only available smart speaker that supports Cantonese</description>
      <arm_group_label>Voice-activated Intelligent Personal Assistant (VIPA) intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Cantonese-speaking Hong Kong permanent resident&#xD;
  &#xD;
            -  Diagnosed with Parkinson's disease&#xD;
  &#xD;
            -  Level 1-4 in the H&amp;Y scale (Hoehn &amp; Yahr, 1967)&#xD;
  &#xD;
            -  Not currently using or owning VIPA&#xD;
  &#xD;
            -  Has stable Wi-Fi connection at home.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  PWP or their caregivers that fails to provide valid consent&#xD;
  &#xD;
            -  Individuals with hearing loss in both ears&#xD;
  &#xD;
            -  Severe voice impairment&#xD;
  &#xD;
            -  Dementia patients (MoCA score &lt;21)&#xD;
  &#xD;
            -  PWP will leave Hong Kong during the intervention period.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Angela Leung, PhD</last_name>
      <phone>+852 2766 5587</phone>
      <email>angela.ym.leung@polyu.edu.hk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Terence Lau, MSc</last_name>
      <phone>+852 3400 8297</phone>
      <email>terence.lau@connect.polyu.hk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Hong Kong Polytechnic University</name>
        <address>
          <city>Kowloon</city>
          <zip>0000</zip>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Angela Leung, PhD</last_name>
        <phone>+852 2766 5587</phone>
        <email>angela.ym.leung@polyu.edu.hk</email>
      </contact>
      <contact_backup>
        <last_name>Terence Lau, MSc</last_name>
        <phone>+852 3400 8297</phone>
        <email>terence.lau@connect.polyu.hk</email>
      </contact_backup>
      <investigator>
        <last_name>Angela Leung, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <reference>
      <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.</citation>
      <PMID>35459429</PMID>
    </reference>
    <reference>
      <citation>Antonovsky, A. (1987). Unravelling the mystery of health: How people manage stress</citation>
    </reference>
    <reference>
      <citation>Jenkinson, C., Fitzpatrick, R., Peto, V., Greenhall, R., &amp; Hyman, N. (1997). The PDQ-8: development and validation of a short-form Parkinson's disease questionnaire. Psychology and Health, 12(6), 805-814.</citation>
    </reference>
    <reference>
      <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/</citation>
      <PMID>29787044</PMID>
    </reference>
    <reference>
      <citation>Keyes, C. L. (2018). Overview of The Mental Health Continuum Short Form (MHC-SF). doi: 10.13140/RG.2.2.24204.62088.</citation>
    </reference>
    <reference>
      <citation>Brooke, J. (1996). SUS-A quick and dirty usability scale. Usability evaluation in industry, 189(194), 4-7.</citation>
    </reference>
    <reference>
      <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.</citation>
      <PMID>14994958</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>15817019</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>34887173</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>32568107</PMID>
    </reference>
    <reference>
      <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</citation>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
      <investigator_full_name>Dr Angela Leung</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>sense of coherence</keyword>
    <keyword>psychosocial well-being</keyword>
    <keyword>Voice-activated Intelligence Personal assistant</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
      <mesh_term>Parkinsonian Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 28, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT06036771/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06036771
  org study id: HSEARS20221107005
  nct id: NCT06036771
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  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
  masking: Single (Outcomes Assessor)
  masking description: outcome assessors will be blinded to the group allocation.
  measure: 13-item Sense of Coherence Scale
  time frame: [Time Frame: Baseline; 8 weeks; 12 weeks]
  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.
  measure: UCLA three-item loneliness scale
  time frame: [Time Frame: Baseline; 8 weeks; 12 weeks]
  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.
  measure: Parkinson's Disease Questionnaire (PDQ-8)
  time frame: [Time Frame: Baseline; 8 weeks; 12 weeks]
  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.
  measure: EuroQol- 5 dimension- 5 level
  time frame: [Time Frame: Baseline]
  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
  measure: Mental Health Continuum Short Form
  time frame: [Time Frame: Baseline; 8 weeks; 12 weeks]
  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.
  measure: Brief Resilient Coping Scale
  time frame: [Time Frame: Baseline; 8 weeks; 12 weeks]
  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.
  measure: Montreal Cognitive Assessment (MoCA)
  time frame: [Time Frame: Screening; 8 weeks; 12 weeks]
  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.
  measure: System Usability Scale
  time frame: [Time Frame: 8 weeks]
  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
  measure: Self-report VIPA usage
  time frame: [Time Frame: 8 weeks]
  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.
  arm group label: Voice-activated Intelligent Personal Assistant (VIPA) intervention
  arm group type: Experimental
  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 group label: Usual care, no intervention provided
  arm group type: No Intervention
  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: Voice-activated Intelligent Personal Assistant (VIPA)
  description: Apple HomePod mini is selected as the intervention medium of this study as it is the only available smart speaker that supports Cantonese
  arm group label: Voice-activated Intelligent Personal Assistant (VIPA) intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Angela Leung, PhD
  phone: +852 2766 5587
  email: angela.ym.leung@polyu.edu.hk
  last name: Terence Lau, MSc
  phone: +852 3400 8297
  email: terence.lau@connect.polyu.hk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Hong Kong
  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.
  PMID: 35459429
  citation: Antonovsky, A. (1987). Unravelling the mystery of health: How people manage stress
  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.
  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/
  PMID: 29787044
  citation: Keyes, C. L. (2018). Overview of The Mental Health Continuum Short Form (MHC-SF). doi: 10.13140/RG.2.2.24204.62088.
  citation: Brooke, J. (1996). SUS-A quick and dirty usability scale. Usability evaluation in industry, 189(194), 4-7.
  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.
  PMID: 14994958
  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.
  PMID: 15817019
  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.
  PMID: 34887173
  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.
  PMID: 32568107
  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
  responsible party type: Principal Investigator
  investigator affiliation: The Hong Kong Polytechnic University
  investigator full name: Dr Angela Leung
  investigator title: Professor
  mesh term: Parkinson Disease
  mesh term: Parkinsonian Disorders
  sharing ipd: No
  provided document: 