Rapid dEvice Testing pROtocol for Parkinson's Disease

NCT ID: NCT04675853

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-25
• Study Completion Date: 2021-11-25

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.

Conditions

Parkinson Disease; Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with PD

No interventions assigned to this group

Care Partners of PD participants

No interventions assigned to this group

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthMode Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mobile Clinical Research Site

New York, New York, United States

Countries

United States

Other Identifiers

HM041001

Identifier Type: -

Identifier Source: org_study_id