Pressure Injury, Pressure Ulcer, Wheelchair
Conditions
Keywords
Pressure Injury, Pressure Ulcer, Weight Shift, Wheelchair, Pressure monitoring, Pressure relief
Brief summary
Pressure-related injuries in individuals with SCI and persons who use wheelchairs are one of the most dangerous secondary health problems encountered throughout the lifespan. With recurrence rates as high as 79% and mortality rates as high as 48% when sepsis is present, there exists a critical clinical need to target prevention of pressure injuries. This study will examine the effects of two novel seat mapping technologies (AW-Shift and Sensoria) on increasing in-seat movement in persons who may be at risk for pressure injuries due to altered sensation on their sitting surface. AW-Shift provides a visual display about pressure distribution directly between the body and the seat cushion to a wheelchair user outside of a clinical setting. Sensoria represents a novel technology to promote tissue health by providing users with information about their daily in-seat movement and providing weight shift reminders that are based on time since previous weight shift activities. Changes in the frequency of in-seat movement behaviors will be compared between baseline and each intervention period.
Detailed description
For almost 50 years, clinicians and researchers have been interested in devices to monitor pressure and weight shift frequency, send alerts, provide cues, or track movement patterns in wheelchair users. Despite the prevention efforts implemented over the years, pressure injuries continue to occur at a high rate of incidence. Without sensation to guide the need for changes in position to alleviate pressure, individuals with decreased sensation move significantly less than individuals with normal sensory systems. Thus, movement is a potentially robust protective factor to target. When focusing on movement as a modifiable risk factor, there is evidence that more in-seat movement is protective in wheelchair users. Behaviors, such as weight shifting to relieve pressure, decay over time, which could be attributed to lack of sensation to provide a natural cue to move. More work is needed to understand the types of movement that are most beneficial, and how to empower wheelchair users to move more often. Our hypotheses are that A) Individuals will complete more frequent and more consistent weight shifts with access to the feedback systems compared to baseline and B) Self-efficacy beliefs for completing weight shifts will increase with use of the feedback systems. This study will examine the effects of two novel seat mapping technologies (AW-Shift and WiSAT) on increasing in-seat movement in persons who may be at risk for pressure injuries due to altered sensation on their sitting surface. AW-Shift provides a rich visual display about pressure distribution directly between the body and the seat cushion to a wheelchair user outside of a clinical setting. WiSAT represents a novel technology to promote tissue health by providing users with information about their daily in-seat movement and providing weight shift reminders that are based on time since previous weight shift activities. Changes in the frequency of in-seat movement behaviors will be compared between baseline and each intervention period. The successful completion of this project will make large advancements in optimizing feedback about pressure and movement that will help wheelchair users become more effective in managing pressure distribution on an ongoing, daily basis.
Interventions
BEHAVIORALSensoria
The Sensoria system uses a force-sensing mat installed under the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays information about weight shifts, goal-setting functions, and feedback on performance/outcomes.
BEHAVIORALAW-Shift
The AW-Shift system uses a pressure-sensing mat installed on top of the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays visual representation of the seating surface and can set reminders for weight shifts.
Sponsors
National Institute on Aging (NIA)
University of Minnesota
Georgia Institute of Technology
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Be able to come to Mayo Clinic, UMN, or Georgia Tech campuses for study visits, or participate in virtual video study visits; * Use a skin protection and positioning wheelchair cushion; * Be able to perform weight shifts independently without assistance of another person (by moving themselves or using of power tilt); * Own and are able to operate a smartphone with Apple or Android operating system; * Are willing to download and use the mobile apps on their phone
Exclusion criteria
* Are scheduled for flap surgery; * There is an active stage 3, 4, or unstageable pressure injury as defined by the National Pressure Injury Advisory Panel definitions anywhere on their sitting surface at time of enrollment; * Use of a custom molded wheelchair cushion or alternating air cushion; * Have/use the recline function on their manual or power wheelchair; * Have a prescribed or limited sitting time of less than 5 hours per day; * Live in a long-term care facility or group home and require 24 hours/day assistance; * Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normalized Weight Shift Frequency (Weight Shifts/Hour) | The outcome measure was assessed at week 4 (the end) of each intervention period. | The normalized average weight shift frequency per hour of wheelchair occupancy for each intervention phase. For each day of the intervention phases, a total number of weight shifts are measured per day in each phase. The total number of weight shifts are normalized by dividing by the number of hours of wheelchair occupancy for each day. Then finally, for each phase, the normalized average weight shift frequency is calculated by averaging across the daily normalized weight shift frequency for each phase. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sensoria First Intervention Group 1 participants will receive the Sensoria intervention during the first intervention phase for 4 weeks, and then the AW-Shift intervention during the second intervention phase for 4 weeks.
Sensoria: The Sensoria system uses a force-sensing mat installed under the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays information about weight shifts, goal-setting functions, and feedback on performance/outcomes.
AW-Shift: The AW-Shift system uses a pressure-sensing mat installed on top of the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays visual representation of the seating surface and can set reminders for weight shifts. | 18 |
| AW-Shift First Intervention Group 2 participants will receive the AW-Shift intervention during the first intervention phase for 4 weeks, and then the Sensoria intervention during the second intervention phase for 4 weeks.
Sensoria: The Sensoria system uses a force-sensing mat installed under the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays information about weight shifts, goal-setting functions, and feedback on performance/outcomes.
AW-Shift: The AW-Shift system uses a pressure-sensing mat installed on top of the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays visual representation of the seating surface and can set reminders for weight shifts. | 12 |
| Total | 30 |
Baseline characteristics
| Characteristic | AW-Shift First Intervention | Total | Sensoria First Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 4 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 26 Participants | 14 Participants |
| Age, Continuous | 42.92 years STANDARD_DEVIATION 12 | 46.47 years STANDARD_DEVIATION 13.48 | 48.83 years STANDARD_DEVIATION 14.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 11 Participants | 26 Participants | 15 Participants |
| Region of Enrollment United States | 12 participants | 30 participants | 18 participants |
| Sex: Female, Male Female | 6 Participants | 14 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 16 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 12 |
| other Total, other adverse events | 0 / 18 | 0 / 12 |
| serious Total, serious adverse events | 0 / 18 | 0 / 12 |
Outcome results
Primary
Normalized Weight Shift Frequency (Weight Shifts/Hour)
The normalized average weight shift frequency per hour of wheelchair occupancy for each intervention phase. For each day of the intervention phases, a total number of weight shifts are measured per day in each phase. The total number of weight shifts are normalized by dividing by the number of hours of wheelchair occupancy for each day. Then finally, for each phase, the normalized average weight shift frequency is calculated by averaging across the daily normalized weight shift frequency for each phase.
Time frame: The outcome measure was assessed at week 4 (the end) of each intervention period.
Population: Analysis population for each arm includes participants who had usable data who completed that intervention, regardless of which was completed first. Some participants completed both interventions and will be included in both arms. Some participants were not appropriate for both interventions and only completed 1, but were still included in analysis because they had usable data and completed at least 1 intervention period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Who Completed Sensoria Intervention | Normalized Weight Shift Frequency (Weight Shifts/Hour) | 2.41 normalized weight shifts per hour | Standard Deviation 1.93 |
| Participants Who Completed AW-Shift Intervention | Normalized Weight Shift Frequency (Weight Shifts/Hour) | 2.38 normalized weight shifts per hour | Standard Deviation 2.03 |