Study Rationale: SPARX3 is a Phase 3 clinical trial designed to assess whether high intensity aerobic exercise can delay progression of Parkinson’s disease (PD) better than does moderate intensity aerobic exercise. Although SPARX3 includes 25 major medical centers in the US and Canada, these sites do not demonstrate proportional representation of the Hispanic population. Our goal is to increase the recruitment of individuals underrepresentd in PD research into SPARX3 by reducing the waiting time for appointments and by targeting population centers with a high proportion of underrepresented potential participants.
Hypothesis: We hypothesize that we can increase the enrollment of underrepresented participants in the SPARX3 clinical trial via targeted enrollment strategies.
Study Design: The three sites involved in this study — UT Health San Antonio (UT Health SA), Columbia University and the University of Utah — will develop targeted, community-based outreach programs to recruit more Hispanic participants (with Utah additionally focusing on Pacific Islander and indigenous individuals). UT Health SA and Columbia will also reach out to programs within the university that successfully recruit minority participants, and UT Health SA will work on reducing time to see a PD expert.
Impact on Diagnosis/Treatment of Parkinson’s Disease: Disparities clearly exist in enrollment in PD Phase 3 clinical trials, leaving us uncertain whether the study findings will apply to the population at large. Moreover, it is not clear that different ethnic groups will adhere to and benefit from interventions to the same extent.
Next Steps for Development: The next step will be to determine the cost associated with recruiting underrepresented participants to Phase 3 clinical trials, a value we expect to exceed $10,000 per recruit. Our findings will guide reduction of health disparities in future clinical trials.
Trial Phase: The next phase will be to demonstrate effectiveness of aerobic interventions across a broad population in implementation studies.