Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04168450 |
| Other study ID # |
STUDY19090305 |
| Secondary ID |
W81XWH-17-1-0221 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 13, 2020 |
| Est. completion date |
June 17, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Individuals who use wheelchairs are at an increased risk of developing pressure injuries on
the parts of the body that are in constant contact with the wheelchair. The development of
pressure injuries can cause reduced mobility, reduced activity and participation, greater
unemployment, increased risk for future pressure injury development, and premature death.
There are numerous risk factors associated with developing pressure injuries. Individuals can
reduce the risk of pressure injury formation by changing positions, weight-shifting, and
using special cushions, but many people still struggle with pressure injuries.
This study is designed to assess the clinical effectiveness of WiSAT (Wheelchair in-Seat
Activity Tracker). WiSAT is a tool designed to help prevent the development of pressure
ulcers by changing behaviors that can lead to pressure ulcers. WiSAT monitors and provides
real-time feedback on weight shifts and pressure relief behaviors while sitting in a
wheelchair.
Description:
Pressure injuries are a serious health concern for individuals who use wheelchairs.
Wheelchair users are at an increased risk of developing pressure injuries on the parts of the
body that are in constant contact with the wheelchair. The development of pressure injuries
can cause negative consequences on their lives. Pressure injuries often lead to reduced
mobility, reduced activity and participation, greater unemployment, increased risk for future
pressure injury development, and premature death. Some risk factors associated with
developing pressure injuries include continual pressure, nutrition, shear forces, and
moisture. Individuals whose use wheelchairs can reduce the risk of pressure injury formation
by changing positions, weight-shifting, and using skin protection cushions, but many people
still struggle with pressure injuries.
This study will assess the clinical effectiveness and usability of WiSAT (Wheelchair in-Seat
Activity Tracker). WiSAT provides real-time feedback on in-seat movement, including
volitional pressure reliefs and weight-shift activity. The study's aim is to assess whether
monitoring and feedback of in-seat movement can change the behavior of wheelchair users by
increasing movement activities.
Study Protocol: The study will prospectively collect in-seat movement activity during
everyday life for wheelchair users at risk for pressure ulcers. 25 individuals who are
full-time users of wheelchairs and have a self-reported risk for pressure ulcers on the
buttocks (sacrum/coccyx, ischial tuberosity, trochanter) will be recruited for the study.
Each person will have two appointments with investigators to educate, set them up with the
WiSAT system and finally to remove the sensor system from the cushion.
The first visit will take approximately 1.5 to 2 hours, in which participants will provide
written informed consent. During this visit, demographic and clinical information will be
collected via self-report. All participants will then receive education about skin health
including information about pressure ulcers, prevention strategies such as pressure relieving
techniques in both bed and wheelchair, and the importance of checking skin regularly for
signs of pressure issues. The WiSAT hardware will be placed within the cover and beneath
their current wheelchair cushion to measure and transmit baseline seat movement activity;
with no mobile application and visual feedback initiated at this time. Subjects' baseline
behavior will be monitored for two weeks to serve as the comparator for the enabled WiSAT
system.
After 14 days of baseline monitoring, the app will automatically switch to feedback mode.
Participants will be informed that they can now monitor their movement activity. Each subject
will be given the ability to set his or her own goals using the app settings. The movement
activity feedback will be provided passively for four weeks, requiring them to view the
application on their smartphone to see daily movement activity data.
After the four weeks of app use, recorded movement activity will be used to categorize
participants as meeting or not meeting the movement threshold. Subjects who do not attain
their movement threshold will be provided with active feedback using audible and/or haptic
reminders. Those who have reached their threshold will continue to access the app to review
their activity (passive feedback).
All participants will be followed for a total of 2.5 months: 2 weeks baseline, 4 weeks
passive visual feedback only, and 4 weeks of passive and/or active feedback. At the end of
the study, the team will collect feedback on usability and acceptability of the activity
tracker.
