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RETRO-PD: Rapid dEvice Testing pROtocol for Parkinson's Disease

Sponsor
HealthMode Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04675853
Collaborator
(none)
12
Enrollment
1
Location
12
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an 8 week observational study to evaluate the feasibility of using remote monitoring technologies in future studies of PD. The study will 2 clinical evaluations (one initial, one final), and an 8-week monitoring period including 4 virtual visits where participants will use a combination of digital devices (Emerald touchless sensor system with associated ankle accelerometer, iPhone, Apple Watch, iPad, Fitbit Aria, FitBit Versa, Withings Blood Pressure Monitor Connect, and/or Withings Sleep Mat) during their daily lives.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    12 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Rapid dEvice Testing pROtocol for Parkinson's Disease (RETRO-PD)
    Actual Study Start Date :
    Nov 25, 2020
    Actual Primary Completion Date :
    Nov 25, 2021
    Actual Study Completion Date :
    Nov 25, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Participants with PD
    Care Partners of PD participants

    Outcome Measures

    Primary Outcome Measures

    1. The feasibility of digital and remote monitoring technologies [8 weeks]

      determined by evaluating: Ease of deployment and initial set-up, utility of technology and user experience as reported by the usability surveys and interview questionnaires (measured by means of Standard Usability Questionnaire score ranges from 10 to 50, higher score indicating a better usability) Total time and percentage of continuous data collection for each stream of data and frequency and distribution of missing data points. Mutual consistency of data from multiple, related data streams Data utility reports Responses from participants with PD and care partners regarding ease of use and comfort of technologies in study Adherence of participants to active tasks and use of the devices

    Secondary Outcome Measures

    1. Correlation with standard measures [8 weeks]

      Correlation of data from the included digital technologies and their relationship to standard measures (correlations with scores from MDS-UPDRS, PDQ-8 and SE-ADL)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Participants with PD

    • At least 30 years of age

    • Clinical diagnosis of PD by a neurologist or other movement disorder specialist as reported by the participant, with current motor symptoms

    • Able to ambulate independently (assistance of minor walking aids such as a cane is permitted, but depending on a walker for ambulation is not)

    • Have a BMI of 33 or below calculated by participant reported height and weight at the time of screening

    • Have a care partner who meets the study's inclusion criteria

    • Able to read, understand, and provide written informed consent in English

    • Able, either alone or with a care partner, to operate digital devices

    • Have reliable wifi in their home and the ability to connect new devices to their home wifi

    Care partners

    • At least 18 years of age

    • Able to read, understand, and provide written informed consent in English

    • Able to operate digital devices

    • Care partner for the participant with PD enrolled in the study

    • Lives with the participant with PD enrolled in the study

    • Able to ambulate independently (assistance of minor walking aids such as a cane is permitted, but depending on a walker for ambulation is not)

    • Willing to exclude pet from the participant's bedroom at night for the duration of the study

    Exclusion Criteria:

    Participants with PD

    • Any non-PD forms of Parkinsonism

    • Active psychiatric disorders that affect the ability to complete study tasks

    • Any other medical condition that is the primary cause of the present movement disorder

    • Cognitive dysfunction (score > 7 on the Six-Item Cognitive Impairment Test)

    • Considered by the investigator to be an unsuitable participant

    • Live in a household with more than three people

    • Unwilling to exclude pet from their bedroom at night for the duration of the study

    Care partners

    • Cognitive dysfunction (score > 7 on the Six-Item Cognitive Impairment Test)

    • Considered by the investigator to be an unsuitable participant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mobile Clinical Research Site New York New York United States 10001

    Sponsors and Collaborators

    • HealthMode Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HealthMode Inc.
    ClinicalTrials.gov Identifier:
    NCT04675853
    Other Study ID Numbers:
    • HM041001
    First Posted:
    Dec 19, 2020
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Jul 22, 2022