Clinical trial NCT04163913: Radial Medical - GAPS
Official title: GAPS: Digital Engagement: The Impact on Subject Compliance and Satisfaction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Male or female over the age of 18
* Undergoing elective primary total hip/knee replacement
* Planned discharge to home
* Able to train to and operate the Cirvo device with app

Exclusion Criteria:

* History of Pulmonary Embolism
* Active cancer
* BMI \>40
* Current smoker
* History of a hyper-coaguable condition
* Actual or expected prolonged bedrest for \>3 days
* Calf geometry on which Cirvo device does not appropriately fit (prospective cohort only)
* Known sensitivity to any of the materials used in the Cirvo device (prospective cohort only)
* Currently participating or planning to participate in any other investigational clinical evaluation during study period that may, in the opinion of the investigator, affect compliance (prospective cohort only)

Primary outcomes:
measure: Change in compliance using Cirvo compression therapy
timeFrame: 14 day visit (+7 days)
Secondary outcomes:
measure: Change in patient satisfaction using Cirvo compression therapy
timeFrame: 14 day visit (+7 days)
measure: Change in staff satisfaction using Cirvo compression therapy.
timeFrame: 14 day visit (+7 days)
measure: Change in patients satisfaction using Cirvo compression therapy
timeFrame: 30 day visit
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: James Slover, MD
role: PRINCIPAL_INVESTIGATOR
References: