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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Parkinson Disease

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Mobile Clinical Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study will enroll at least 25 dyads consisting of participants with PD and their care partners recruited from multiple clinical practices and the general public. Participants who withdraw from the study before completing virtual visit V04 (day 28) will be replaced. Enrollment will be enriched to ensure that participants are distributed across mild to severe PD.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Participants with PD
Care Partners of PD participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The feasibility of digital and remote monitoring technologies	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	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation with standard measures	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)	8 weeks

Collaborators and Investigators

• Sponsor: HealthMode Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Actual): November 25, 2021
• Study Completion (Actual): November 25, 2021

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: HM041001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No