ArticleJMIR research protocols2025
Improving Prediction of Falls and Cognitive Impairment in Parkinson Disease: Protocol for a Decentralized Observational Study.
Article in JMIR research protocols, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 3 Double-blind Placebo-controlled Parallel Group Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson Disease
A Randomized, Double-blind, Placebo-controlled Trial of Urate-elevating Inosine Treatment to Slow Clinical Decline in Early Parkinson's Disease
Tele-health Outcomes as Digital Biomarkers of Parkinson's Disease Progression During Extended Follow up of STEADY-PD3 and SURE-PD3 Trial Participants
Parkinson's Foundation: PD Generation: Mapping the Future of Parkinson's Disease
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23 authors.
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Abstract
backgroundFalls and cognitive impairment are major sources of disability in Parkinson disease (PD). The ability to accurately identify individuals with PD at high risk for falls and cognitive impairment would provide an opportunity for intervention and potentially improve long-term outcomes. In a previous study, Assessing Telehealth Outcomes in Multiyear Extensions of Parkinson Disease Trials (AT-HOME PD), we remotely characterized participants with early PD who had participated in 1 of 2 PD clinical trials over 2 years of follow-up. These participants with advancing disease provide a unique opportunity to examine whether the capture of objective in-home measures via digital tools and bothersome symptoms via direct participant report improves the prediction of disease milestones.
objectiveAssessing Telehealth Outcomes in Multiyear Extensions of Parkinson Disease Trials-2 (AT-HOME PD2) aims to examine whether digital tools and remote participant reporting can improve the prediction of falls and cognitive impairment, quantify changes in physical activity over time, and explore the relationship between physical activity and clinical progression over time.
methodsThis is a decentralized observational study of up to 200 individuals with PD, with clinical and digital phenotyping for up to 3 years of follow-up. Participants are those who took part in the STEADY-PD III (NCT02168842), Study of Urate Elevation in Parkinson's Disease, Phase 3 (SURE-PD3; NCT02642393), AT-HOME PD (NCT03538262), or PD GENEration (NCT04057794) studies. All participants complete 2 video visits per year, wear 2 wrist-worn sensors (Fitbit Charge 5 and ActiGraph CentrePoint Insight Watch) for 1 week each month, complete smartphone-based motor tasks (using the mPower 2.0 app) for 10 days each quarter, and complete online surveys (within the companion Fox Insight study) each quarter. Falls are assessed via a weekly automated telephone call. A cognitive diagnosis is determined by a consensus committee that considers scores on a global cognitive measure, detailed neuropsychological tests, a cognitive-related disability measure, and clinical information. Prediction models will be constructed, and prediction accuracy will be compared across the models.
resultsRecruitment for the study was initiated in September 2023. Enrollment is ongoing, with 142 participants enrolled as of January 2025. Within the cohort, the average age is 69.2 (SD 8.7) years; 85 (59.9%) participants are male, 137 (96.5%) are White, and 2 (1.4%) are Hispanic or Latino; and the average disease duration is 8.9 (SD 1.3) years.
conclusionsAT-HOME PD2 is remotely clinically and digitally phenotyping participants with midstage PD to predict falls and cognitive impairment and to provide insights into long-term progression. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71955.
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