Rapid dEvice Testing pROtocol for Parkinson's Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Healthy Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mobile Clinical Research Site

New York, 10001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The feasibility of digital and remote monitoring technologies

Time frame: 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 outcomes

Correlation with standard measures

Time frame: 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)

Sponsors and collaborators

Lead sponsor

HealthMode Inc.

Industry

Registry information

Official study title

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

Acronym: RETRO-PD

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Dec 19, 2020
Registry last updated: Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed