Trial Outcomes & Findings for Wearable Technology to Reduce Risk of DVT and Increase Patient Compliance (NCT NCT04995601)
NCT ID: NCT04995601
Last Updated: 2024-09-05
Results Overview
Compare patient compliance (percentage of prescribed use/24hr) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients.
COMPLETED
NA
106 participants
day 1 postoperative joint replacement
2024-09-05
Participant Flow
Participant milestones
| Measure |
Standard of Care
Participants received DVT prophylaxis using standard intermittent pneumatic compression during postoperative care after total joint replacement.
|
Recovery Force MAC
Participants received DVT prophylaxis using the RF Health MAC during postoperative care after total joint replacement.
RF Health MAC: The RF Health MAC is a novel device that is applied to the lower legs of patients that provides intermittent active compressions to the calf muscles which results in increased blood flow in the veins, moving blood towards the direction of the heart and reducing the risk of clot formation.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
57
|
|
Overall Study
COMPLETED
|
49
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wearable Technology to Reduce Risk of DVT and Increase Patient Compliance
Baseline characteristics by cohort
| Measure |
Standard of Care
n=49 Participants
Participants received DVT prophylaxis using standard intermittent pneumatic compression during postoperative care after total joint replacement.
|
Recovery Force MAC
n=57 Participants
Participants received DVT prophylaxis using the RF Health MAC during postoperative care after total joint replacement.
RF Health MAC: The RF Health MAC is a novel device that is applied to the lower legs of patients that provides intermittent active compressions to the calf muscles which results in increased blood flow in the veins, moving blood towards the direction of the heart and reducing the risk of clot formation.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Age, Continuous
|
63.6 years
n=5 Participants
|
64.4 years
n=7 Participants
|
64.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
49 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
57 participants
n=7 Participants
|
106 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: day 1 postoperative joint replacementPopulation: Percent Compliance for Day 1 postop
Compare patient compliance (percentage of prescribed use/24hr) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients.
Outcome measures
| Measure |
Standard of Care
n=26 Participants
Participants received DVT prophylaxis using standard intermittent pneumatic compression during postoperative care after total joint replacement.
|
Recovery Force MAC
n=48 Participants
Participants received DVT prophylaxis using the RF Health MAC during postoperative care after total joint replacement.
RF Health MAC: The RF Health MAC is a novel device that is applied to the lower legs of patients that provides intermittent active compressions to the calf muscles which results in increased blood flow in the veins, moving blood towards the direction of the heart and reducing the risk of clot formation.
|
|---|---|---|
|
Compliance to Prescribed Use
|
67.7 percentage of prescribed use/24hr
Standard Deviation 40.1
|
83.3 percentage of prescribed use/24hr
Standard Deviation 25.8
|
PRIMARY outcome
Timeframe: at the end of 14-day data collection periodPopulation: Patient reported outcomes in the hospital (Standard of care vs RF MAC) for overall comfort, where higher score is better device performance (5-pt Likert Scale; 1=Strongly disagree, 2=Disagree, 3=Neutral, 4=Agree, 5=Strongly Agree).
Compare patient-reported comfort (patient reported outcomes in the hospital-standard of care vs RF MAC-for overall comfort, where higher score is better device performance (5-pt Likert Scale; 1=Strongly disagree, 2=Disagree, 3=Neutral, 4=Agree, 5=Strongly Agree) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients.
Outcome measures
| Measure |
Standard of Care
n=36 Participants
Participants received DVT prophylaxis using standard intermittent pneumatic compression during postoperative care after total joint replacement.
|
Recovery Force MAC
n=44 Participants
Participants received DVT prophylaxis using the RF Health MAC during postoperative care after total joint replacement.
RF Health MAC: The RF Health MAC is a novel device that is applied to the lower legs of patients that provides intermittent active compressions to the calf muscles which results in increased blood flow in the veins, moving blood towards the direction of the heart and reducing the risk of clot formation.
|
|---|---|---|
|
Patient-reported Comfort
|
3.1 units on a scale
Standard Deviation 0.5
|
3.5 units on a scale
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: at the end of 14-day data collection periodPopulation: Patient reported ease-of-use (using the System Usability Scale, with a range of 0-21, where higher score =higher ease of use) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients.
Compare patient-reported ease-of-use (using the System Usability Scale, with a range of 0-21, where higher score =higher ease of use) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients.
Outcome measures
| Measure |
Standard of Care
n=36 Participants
Participants received DVT prophylaxis using standard intermittent pneumatic compression during postoperative care after total joint replacement.
|
Recovery Force MAC
n=44 Participants
Participants received DVT prophylaxis using the RF Health MAC during postoperative care after total joint replacement.
RF Health MAC: The RF Health MAC is a novel device that is applied to the lower legs of patients that provides intermittent active compressions to the calf muscles which results in increased blood flow in the veins, moving blood towards the direction of the heart and reducing the risk of clot formation.
|
|---|---|---|
|
Patient-reported Ease-of-use
|
2.6 units on a scale
Standard Deviation 0.4
|
2.3 units on a scale
Standard Deviation 0.3
|
Adverse Events
Standard of Care
Recovery Force MAC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeff Schwegman (PI), Dr. Karen Giuliano (PI, clinical trial subaward)
Recovery Force Health, University of Massachusetts Amherst
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place