Osteoarthritis Clinical Trial
Official title:
GAPS: Digital Engagement: The Impact on Subject Compliance and Satisfaction
NCT number | NCT04163913 |
Other study ID # | 19-01399 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2019 |
Est. completion date | June 2022 |
Verified date | October 2020 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2022 |
Est. primary completion date | June 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in compliance using Cirvo compression therapy | A sample size of 100 subjects is powered at 90% to show a difference of 10% in compliance between the 2 digital engagement cohorts. For each subject, Compliance will be calculated for each participant during the course of therapy in terms of the number of hours of actual use/number of hours of prescribed use. The number of hours will be summarized as days of use for each group. The means of each group will be presented. The primary endpoint is the difference in compliance between the group assigned to digital engagement versus no digital engagement with the Cirvo app. The mean difference will be compared to zero using the paired t-test |
14 day visit (+7 days) | |
Secondary | Change in patient satisfaction using Cirvo compression therapy | A comparison between the satisfaction of CirvoTM therapy versus the historical data from comparator device use will be performed. Results of the usability questionnaire (Patient Satisfaction Intermittent Compression Devices Questionnaire) will be qualitatively summarized. | 14 day visit (+7 days) | |
Secondary | Change in staff satisfaction using Cirvo compression therapy. | A comparison between the satisfaction of CirvoTM therapy versus the historical data from comparator device use will be performed. Results of the usability questionnaire will be qualitatively summarized. Staff Satisfaction Intermittent Compression Devices Questionnaire will be administered. | 14 day visit (+7 days) | |
Secondary | Change in patients satisfaction using Cirvo compression therapy | A comparison between the satisfaction of CirvoTM therapy versus the historical data from comparator device use will be performed. Results of the usability questionnaire (Patient Satisfaction Intermittent Compression Devices Questionnaire) will be qualitatively summarized. | 30 day visit |
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