Project VOICE: vascular Outcomes Improvement Through Collection of PatiEnt Reported Data

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
This is a two center, non‐blinded, 2 period randomized crossover trial. 50 patient subjects are planned. Patient participants will be identified and recruited from clinical environments (including clinics and diagnostic testing departments) at participating sites. Diagnosis and testing will occur through usual clinical care, and participants will not incur financial costs related to participation. A crossover design will be utilized, where all participants will use the VOICE platform with activity tracking for 35 days and usual care for 30 days. Randomization will determine the order in which participation in the VOICE phase versus the usual care phase occur. Randomization will occur using a closed envelope system. For patients in the VOICE platform group, data collection will occur over a total of 35 days, including an initial 5‐day "run in" period during which participants will orient themselves to the system. Each provider participant will receive a single end‐user survey evaluating VOICE from their perspective. Screening of patients electronic medical records will be done to determine subject eligibility. Subjects who meet all inclusion criteria will be approached to participate. Total duration of subject participation will be 9 weeks during the control and intervention phases, with a final follow‐up survey at 6 months post‐enrollment.
Epistemonikos ID: 487c4a9aacf5159770c1d3f963c7c3de8b2ec74e
First added on: May 21, 2024