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Evaluation of Wheelchair In-Seat Activity Tracker (WiSAT)

Primary Purpose

Pressure Ulcer, Buttock, Pressure Injury, Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WiSAT System, Passive Feedback
WiSAT System, Active Feedback
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer, Buttock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Use a wheelchair as their primary means of mobility
  • Have a self-reported history of pressure ulcers on the buttocks within the past three years
  • Age 18 or older
  • Use a smartphone with an operating system upgraded in the last 5 years
  • Use a skin protection cushion or skin protection/positioning cushion

Exclusion Criteria:

  • None

Sites / Locations

  • Edward Hines, Jr. VA Hospital
  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

WiSAT Passive

WiSAT Active

Arm Description

This arm is composed of participants who meet their activity threshold over the 4-week period.

This arm is composed of participants who do not meet their activity threshold over the 4-week period.

Outcomes

Primary Outcome Measures

Change from baseline in average daily movement activity at 5 months
Average daily movement activity is defined as the frequency of in-seat movement will be calculated as total number of weight shifts and pressure reliefs per unit time of wheelchair use (movements/hour).

Secondary Outcome Measures

Full Information

First Posted
November 15, 2019
Last Updated
August 9, 2022
Sponsor
University of Pittsburgh
Collaborators
Georgia Institute of Technology, United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04168450
Brief Title
Evaluation of Wheelchair In-Seat Activity Tracker
Acronym
WiSAT
Official Title
Evaluation of the Wheelchair In-Seat Activity Tracker (WiSAT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
June 17, 2022 (Actual)
Study Completion Date
June 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Georgia Institute of Technology, United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Buttock, Pressure Injury, Pressure Ulcer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WiSAT Passive
Arm Type
Other
Arm Description
This arm is composed of participants who meet their activity threshold over the 4-week period.
Arm Title
WiSAT Active
Arm Type
Other
Arm Description
This arm is composed of participants who do not meet their activity threshold over the 4-week period.
Intervention Type
Other
Intervention Name(s)
WiSAT System, Passive Feedback
Intervention Description
The WiSAT system is installed in the participant's wheelchair cushion and a smartphone application is installed on his/her cellphone. Participants are able to view the application as they please and they will receive no notifications from the app regarding their movement goals.
Intervention Type
Other
Intervention Name(s)
WiSAT System, Active Feedback
Intervention Description
The WiSAT system is installed in the participant's wheelchair cushion and smartphone application is installed on his/her cellphone. Participants receive notifications from the app to help them meet their movement goals.
Primary Outcome Measure Information:
Title
Change from baseline in average daily movement activity at 5 months
Description
Average daily movement activity is defined as the frequency of in-seat movement will be calculated as total number of weight shifts and pressure reliefs per unit time of wheelchair use (movements/hour).
Time Frame
baseline (2 weeks) and 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Use a wheelchair as their primary means of mobility Have a self-reported history of pressure ulcers on the buttocks within the past three years Age 18 or older Use a smartphone with an operating system upgraded in the last 5 years Use a skin protection cushion or skin protection/positioning cushion Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia E Karg, MS
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
Facility Information:
Facility Name
Edward Hines, Jr. VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified research data may in the future be shared upon request with investigators external to the study team who are conducting similar research with an approved IRB. Research data including time in wheelchair, weight shift frequency, and demographics may be shared.
IPD Sharing Time Frame
Any time after primary and secondary publications
IPD Sharing Access Criteria
To be determined.

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Evaluation of Wheelchair In-Seat Activity Tracker

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