# Assessing Tele-Health Outcomes in Multiyear Extensions of Parkinson's Disease Trials-2 (AT-HOME PD-2)

> **NIH NIH R01** · UNIVERSITY OF ROCHESTER · 2024 · $954,355

## Abstract

The COVID-19 pandemic has disrupted clinical research and highlighted the value of patient centered research
methods that enable participation from the home and collection of data directly from participants. Such
decentralized research studies that harness video visits, digital tools and participant reporting, can reach a large,
geographically dispersed population of participants, increase the frequency and scope of evaluation, and reduce
the burden of participation. Parkinson’s disease, a clinically heterogeneous neurodegenerative disorder that
causes progressive disability, is well suited to such a model. Traditional assessments are typically subjective,
insensitive to change, and limited to episodic administration and therefore fail to capture the complexity of
Parkinson’s disease. AT-HOME PD, the largest on-going decentralized longitudinal observational Parkinson’s
disease study with digital tools, is remotely characterizing ~225 participants with Parkinson’s disease from two
NINDS-funded, phase 3 clinical trials, STEADY-PD III and SURE-PD3. These studies yielded cohorts with
comprehensive clinical phenotyping, whole genome sequencing, and serial plasma collection. AT-HOME PD
participants are being characterized through video visits, smartphone-based assessments, and an online survey
platform. The cohort is now approaching mid-stage Parkinson’s disease, presenting an opportunity to advance
our understanding of this under-studied population, improve the prediction of clinically relevant disease
milestones like falls and cognitive impairment, quantify physical activity, and identify sensitive remote disease
measures. This project will extend the follow-up of this cohort by 3 years and expand digital phenotyping of
participants, using smartphone-based assessments and two wrist-worn sensors. The aims of this project are to
1) evaluate the extent to which digital tools and remote participant reporting can improve the prediction of
clinically relevant disease milestones compared with traditional measures, 2) quantify longitudinal change in
physical activity, steps taken, and gait in mid-stage Parkinson’s disease in the real-world, and 3) explore the
relationship between physical activity and clinical outcomes in mid-stage Parkinson’s disease. We will generate
a dataset with approximately 10 continuous years of data on PD progression that begins prior to use of
dopaminergic medications and progresses to midstage Parkinson’s disease and beyond. This rich dataset will
accelerate therapeutic development by filling knowledge gaps in the mid-stage Parkinson’s disease population,
helping to optimize models for conducting patient-centered remote research, evaluating new methods for
predicting disease outcomes, and evaluating remote outcome measures.

## Key facts

- **NIH application ID:** 10819599
- **Project number:** 5R01NS126933-02
- **Recipient organization:** UNIVERSITY OF ROCHESTER
- **Principal Investigator:** Ruth Schneider
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $954,355
- **Award type:** 5
- **Project period:** 2023-05-01 → 2028-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10819599

## Citation

> US National Institutes of Health, RePORTER application 10819599, Assessing Tele-Health Outcomes in Multiyear Extensions of Parkinson's Disease Trials-2 (AT-HOME PD-2) (5R01NS126933-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10819599. Licensed CC0.

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