Clinical trial NCT04675853: Rapid dEvice Testing pROtocol for Parkinson's Disease
Official title: Rapid dEvice Testing pROtocol for Parkinson's Disease (RETRO-PD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Healthy
Lead sponsor: HealthMode Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-19
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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
* 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

Primary outcomes:
measure: The feasibility of digital and remote monitoring technologies
timeFrame: 8 weeks
Secondary outcomes:
measure: Correlation with standard measures
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Mobile Clinical Research Site
state: New York
Study officials:
References: