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. 2022 Jan 21;12(1):371–380. doi: 10.3233/JPD-212935

Table 1.

Study Characteristics

FIVE VALOR-PD AT-HOME PD
Study Design Study Design Cross-Sectional Longitudinal Longitudinal
Study Duration 36 months 24 months
Target Population Fox Insight clinical research participants 23andMe Research Program participants STEADY-PD IIIa and SURE-PD3b clinical trial participants
Number of Investigators 4 5 6
Initial Point of Contact Fox Insight team 23andMe team AT-HOME PD team
Initial Outreach Batched email invitations Batched email invitations Rolling contact by email, mail, and telephone
Customized URL Yes Yes No
Electronic Consent to Contact Yes Yes No
Prescreening Telephone Call Yes Yes Yes
Electronic Consent to Participation Yes Yes Yes
Compensation No Yes Yes
Target number of participants 200 300 420
Main Eligibility Criteria –Adults with and without PD Insight visit –Adult LRRK2 G2019S carriers with and without PD –Adults with PD
–Completed baseline Fox –Aware of carrier status –Participated in STEADY-PD III or SURE-PD3
–Stable medication regimen –Prior consent to research contact –Prior consent to research contact
–Willing to complete all activities within 6 weeks of baseline Fox Insight visit –Access to internet-enabled device –Access to internet-enabled device
–Access to internet-enabled device –U.S. residence
–U.S residence
Study Enrollment Recruitment funnel
  Participants invited, n 2,125 3,808 634c
  Consented to contact, n (%) 374 (17.6%) 376 (9.9%) 505d (79.7%)
  Pre-screened, n (%, %)e 265 (12.5%, 70.9%) 336 (8.8%, 89.4%) 348 (68.9%, 68.9%)
  Consented to study, n (%, %)e 223 (10.5%, 63.5%) 293 (7.7%, 79.2%) 240 (47.5%, 48.4%)
Completed baseline visit, n (%, %)f 203 (101.5%, 57.8%) 277 (92.3%, 74.9%) 226 (53.8%, 45.6%)
Weeks to complete enrollment, n 33 59 61
Enrolled per week, meang 6.2 4.7 3.7
U.S. states represented, n 40 34 42 (+1 Canadian province)
Living in Health Professional Shortage Areash, n (%) 87 (42.9%) 84 (30.3%) 76 (33.6%)
Living in rural areasi, n (%) 29 (14.3%) 13 (4.7%) 20 (8.9%)

aSTEADY-PDIII (Efficacy of Isradipine in Early Parkinson Disease; NCT02168842) was a phase III clinical trial of isradipine, ongoing at the time of AT-HOME PD enrollment. bSURE-PD3 (Study of Urate Elevation in Parkinson’s Disease, Phase 3; NCT02642393) was a phase III clinical trial of inosine, ongoing at the time of AT-HOME PD enrollment. cAs participation in either STEADY-PDIII or SURE-PD3 was an eligibility requirement for AT-HOME PD, the pool of all participants from the parent studies (n = 634) were considered to be the maximum number of individuals “invited” to participate. dAll participants from the STEADY-PDIII and SURE-PD3 studies that 1) were not deceased, 2) had not left the study and 3) had given consent to be contacted for future research studies (n = 505) were considered potentially eligible for AT-HOME PD. ePercentages reported are (%of participants invited, %of those consented to contact). fPercentages reported are (%of target, %of those consented to contact). gNumber of participants enrolled per week calculated by dividing the number of completed baseline visits by the number of weeks to complete enrollment. hParticipants were determined to live in a Health Professional Shortage Area (HPSA) if their mailing address zip code was included on the list of all U.S. HPSA zip codes, as determined by the Centers for Medicare & Medicaid Services. iParticipants were determined to live in a rural area if their mailing address zip code was included on the list of all U.S. Federal Office of Rural Health Policy-eligible zip codes, as determined by the Health Resources & Services Administration.