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

HealthMode

Status: Completed

Conditions: Healthy; Parkinson Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT04675853

HM041001

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 2 patient groups

Participants with PD

Care Partners of PD participants