OsteoarthritisNCT04163913
Radial Medical - GAPS
A study testing Change in User interfaces of Cirvo compression device application. and Change in Satisfaction in use of Cirvo device in people with Osteoarthritis, run by NYU Langone Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Change in User interfaces of Cirvo compression device application. and Change in Satisfaction in use of Cirvo device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of Pulmonary Embolism
- Active cancer
- BMI >40
- Current smoker
- History of a hyper-coaguable condition
- Actual or expected prolonged bedrest for >3 days
Show all 9Show fewer
- 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)
About this study
Official title: GAPS: Digital Engagement: The Impact on Subject Compliance and Satisfaction
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Change in User interfaces of Cirvo compression device application., Change in Satisfaction in use of Cirvo device
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in User interfaces of Cirvo compression device application.Other
Comparison of 2 versions of the Circo user interface
Change in Satisfaction in use of Cirvo deviceOther
Comparison of how satisfied patients are with the Cirvo device to a different compression device (ActiveCare)
| Study group | Role | What they receive |
|---|---|---|
| Cirvo Device | Experimental | 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. Receives: Other: Change in User interfaces of Cirvo compression device application.; Other: Change in Satisfaction in use of Cirvo device |
| ActiveCare DVT | Active comparator | A commercially available device was previously used to assess patient satisfaction with compression therapy for DVT prophylaxis as per standard of care. Receives: Other: Change in User interfaces of Cirvo compression device application.; Other: Change in Satisfaction in use of Cirvo device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 day visit (+7 days)
Secondary outcomes (3)
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.
Measured: 14 day visit (+7 days)
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.
Measured: 14 day visit (+7 days)
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.
Measured: 30 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study startNov 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Slover, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163913
- Sponsor's protocol ID
- 19-01399
- Status last verified
- Oct 2020
- First submitted
- 24 Oct 2019
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GAPS: Digital Engagement: The Impact on Subject Compliance and Satisfaction
- ClinicalTrials.gov ID
- NCT04163913
- Acronym / sponsor ID
- 19-01399
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cirvo Device | Experimental | Other: Change in User interfaces of Cirvo compression device application., Other: Change in Satisfaction in use of Cirvo deviceThe 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. |
| ActiveCare DVT | Active comparator | Other: Change in User interfaces of Cirvo compression device application., Other: Change in Satisfaction in use of Cirvo deviceA commercially available device was previously used to assess patient satisfaction with compression therapy for DVT prophylaxis as per standard of care. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- History of Pulmonary Embolism
- Active cancer
- BMI >40
- Current smoker
- History of a hyper-coaguable condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change in User interfaces of Cirvo compression device application.Comparison of 2 versions of the Circo user interface | Other | ActiveCare DVT, Cirvo Device |
| Change in Satisfaction in use of Cirvo deviceComparison of how satisfied patients are with the Cirvo device to a different compression device (ActiveCare) | Other | ActiveCare DVT, Cirvo Device |
Primary outcome
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
3 secondary outcomes
Change in patient satisfaction using Cirvo compression therapy
Time frame: 14 day visit (+7 days)
Change in staff satisfaction using Cirvo compression therapy.
Time frame: 14 day visit (+7 days)
Change in patients satisfaction using Cirvo compression therapy
Time frame: 30 day visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Slover, MD principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
A study testing Change in User interfaces of Cirvo compression device application. and Change in Satisfaction in use of Cirvo device in people with Osteoarthritis, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in compliance using Cirvo compression therapy (time frame: 14 day visit (+7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.