Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Pressure Injury
  • Pressure Ulcer
  • Pressure Ulcer, Buttock
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 consequence...

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. Seventy-six 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 5 months: 2 weeks baseline, four weeks passive visual feedback only, and 3.5 months of passive and/or active feedback. Once the participants have completed their 5 months of using WiSAT, they will return to clinic for their second visit. The second visit will last for approximately one hour. During this visit, the WiSAT system will be to removed and the study team will collect feedback on usability and acceptability of the activity tracker.

Tracking Information

NCT #
NCT04168450
Collaborators
  • Georgia Institute of Technology
  • United States Department of Defense
Investigators
Study Director: Patricia E Karg, MS University of Pittsburgh