Study Rationale: The Parkinson’s Disease-Health Index (PD-HI) is a novel, disease specific patient-reported outcome (PRO) measure designed for use in clinical trials to track clinically meaningful changes in health in response to therapeutic intervention in Parkinson’s disease (PD). The goal of this research is to collect longitudinal data using the PD-HI and other commonly used PRO measures to add to existing PD clinical trial infrastructure, optimize existing outcome measures, identify potentially modifiable factors that are associated with disease progression and promote future therapeutic development for people with PD.
Hypothesis: This research seeks to determine the longitudinal performance metrics of the PD-HI, collect detailed natural history data in PD and determine demographic and disease-specific characteristics associated with faster or slower disease progression.
Study Design: Study participants will complete demographic questions, the PD-HI, the Neuro-Qol, the MDS-UPDRS, and an instrument preference survey at baseline, 6 months, 12 months, 18 months and 24 months. In addition, participants will complete a global impression of change survey at 6 months, 12 months, 18 months, and 24 months. These surveys will track patient-reported disease burden over time, determine participant preferences in using the different clinical trial PROs and obtain detailed demographic and disease-specific characteristics of the study sample population.
Impact on Diagnosis/Treatment of Parkinson’s disease: This research will provide longitudinal data across 24 months, enabling researchers to efficiently plan future clinical trials and interpret data collected using the PD-HI. This work will also maximize the ability of the PD-HI to measure small but clinically relevant changes in health in response to therapeutic intervention.
Next Steps for Development: Upon completion of this work, we will partner with academic groups, foundations, and pharmaceutical companies to implement the PD-HI in clinical trials and studies of PD. We will publish this longitudinal data for the PD research community to facilitate the planning and efficiency of future PD clinical trials.