GAPS: Digital Engagement: The Impact on Subject Compliance and Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in compliance using Cirvo compression therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Change in compliance using Cirvo compression therapy
时间窗: 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
次要结局
- 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)