GAPS: Digital Engagement: The Impact on Subject Compliance and Satisfaction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- NYU Langone Health
- Primary Endpoint
- Change in compliance using Cirvo compression therapy
Study Overview
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.
- 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.
- Post procedure: After the procedure, CirvoTM device operation will be reviewed with the participant.
- Discharge: Any adverse events occurring during hospitalization will be reviewed, data capture on the CirvoTM app will be confirmed.
- 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.
- 30-day phone call/visit: Participants will be contacted at 30 days to answer questions about DVT's and readmissions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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)
Arms & Interventions
Cirvo Device
The CirvoTM device (Figure 1) is a lightweight, mobile, active, intermittent leg compression device placed on the calf of the leg, using hook and loop (e.g. Velcro) straps in the similar manner as commercially available intermittent leg compression devices The system utilizes an electro-mechanical drive system to intermittently compress the calf from the ankle toward the knee for a duration and compression level prescribed by the physician. The level of compression delivered by the CirvoTM therapy will be in the same range as existing devices which corresponds to the type of pressure applied by a blood pressure cuff.
Intervention: Change in User interfaces of Cirvo compression device application. (Other)
Cirvo Device
The CirvoTM device (Figure 1) is a lightweight, mobile, active, intermittent leg compression device placed on the calf of the leg, using hook and loop (e.g. Velcro) straps in the similar manner as commercially available intermittent leg compression devices The system utilizes an electro-mechanical drive system to intermittently compress the calf from the ankle toward the knee for a duration and compression level prescribed by the physician. The level of compression delivered by the CirvoTM therapy will be in the same range as existing devices which corresponds to the type of pressure applied by a blood pressure cuff.
Intervention: Change in Satisfaction in use of Cirvo device (Other)
ActiveCare DVT
A commercially available device was previously used to assess patient satisfaction with compression therapy for DVT prophylaxis as per standard of care.
Intervention: Change in User interfaces of Cirvo compression device application. (Other)
ActiveCare DVT
A commercially available device was previously used to assess patient satisfaction with compression therapy for DVT prophylaxis as per standard of care.
Intervention: Change in Satisfaction in use of Cirvo device (Other)
Outcomes
Primary Outcomes
Change in compliance using Cirvo compression therapy
Time Frame: 14 day visit (+7 days)
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
Secondary Outcomes
- Change in patient satisfaction using Cirvo compression therapy(14 day visit (+7 days))
- Change in staff satisfaction using Cirvo compression therapy.(14 day visit (+7 days))
- Change in patients satisfaction using Cirvo compression therapy(30 day visit)