NCT04163913

Radial Medical - GAPS

GAPS: Digital Engagement: The Impact on Subject Compliance and Satisfaction

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This study will prospectively compare compliance rates between a novel FDA cleared wearable compression therapy with and without digital engagement for DVT prophylaxis in both hospital and home environments after total knee or hip arthroplasty.

Detailed description

This study is a single-arm, open-label, prospective, single-center study designed to evaluate compliance to CirvoTM therapy use with and without digital engagement. Historical questionnaire data with a different compression device will be compared to the same questionnaire used for the prospective cohort of up to 200 subjects. All patients prescribed compression therapy following total joint arthroscopy will be offered participation. Subjects will receive CirvoTM compression therapy according to the standard of care protocol at NYU during or after surgery and 18 hours per day for 14 days. 1. Baseline: Following consent, participants will provide demographic, medical history and information with respect to their elective orthopedic procedure and receive training on the CirvoTM device. Participants will be randomized to either digital engagement or no digital engagement groups. 2. Post procedure: After the procedure, CirvoTM device operation will be reviewed with the participant. 3. Discharge: Any adverse events occurring during hospitalization will be reviewed, data capture on the CirvoTM app will be confirmed. 4. 14- day visit: Participants will complete a patient satisfaction questionnaire, provide information with respect to any adverse events including specific details about DVT and readmission and return the devices. 5. 30-day phone call/visit: Participants will be contacted at 30 days to answer questions about DVT's and readmissions.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
OTHER	Change in User interfaces of Cirvo compression device application.	Comparison of 2 versions of the Circo user interface
OTHER	Change in Satisfaction in use of Cirvo device	Comparison of how satisfied patients are with the Cirvo device to a different compression device (ActiveCare)

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-06-01
• Completion: 2022-06-01
• First posted: 2019-11-15
• Last updated: 2020-10-28