Evaluation of the PPAL

ConditionAge Problems
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlicia Koontz

About this trial

This research study is being conducted to better understand the impact of the PPAL assisted toileting device. The PPAL consists of a powered, height-adjustable commode chair with integrated transfer boards. The system is designed to allow users to assist with their own transfers to and from the bed or chair to the PPAL for toileting, with minimal manual assistance from caregivers. Users who require assistance with transfers, and their caregivers, have a high likelihood of experiencing injury during transfers.

The purpose of this study is to evaluate the PPAL bedside commode in a home setting to better understand the impact of the device during a six-week at-home trial. Participants will be asked to schedule a home visit with the research team to screen their home, answer questions, and observe the participant's current transfer methods to their toilet or commode to ensure that both the participant and caregiver are appropriate candidates for the device. Once approved, a delivery date will be arranged to deliver the PPAL to the participant's home. At the end of the six-week trial, the study team will arrange a final visit to retrieve the PPAL and again ask questions and observe a toilet transfer using both the PPAL and the customary commode. Finally, the investigators will interview the participant and caregiver to assess their satisfaction with the device. This interview will be audio recorded.

This study involves minimal risks, which are expected to occur infrequently. There is a possibility that the participant could experience a scrape, bruise, cut, or pinch injury while using a device with which they are not familiar. There is also the possibility that the participant could fall when attempting to transfer to or from the device; however, the investigators will thoroughly demonstrate the device and monitor its use to minimize this risk. There is also a risk of breach of confidentiality, as text messages and emails may not be encrypted or secure during transmission or storage, and it is possible they could be intercepted or accessed by individuals not associated with this study.

There will be no direct benefit to the participant from participating in the study, but participation will help developers of the PPAL better understand the opinions, needs, and abilities of caregivers and patients who may use the device.

Eligibility criteria

Qualifiers

Age 18 years or above

Weighs 300 pounds or less and is able to fit within the dimensions of the PPAL - Has difficulty with getting on or off a toilet or commode at any point in a typical 24-hour period

Resides in either a home, independent living residence, assisted living or extended care residence

Able to maintain sitting balance independently (without human assistance) for at least 2 minutes

Disqualifiers

Ventilator users

Free of acute medical events within the last 3 months

Had Stage 2 or greater pressure ulcer within the last 3 months

Upcoming planned medical procedures or surgeries in the next 3 months.

Trial design

Treatments tested in this trial

  • PPAL

Treatment groups

16 Participants
are divided into 1 treatment group

Sponsors and collaborators

Alicia Koontz

Lead sponsor

University of Pittsburgh

Sponsor institution

QUA Inc.

Collaborator

National Institute of Nursing Research (NINR)

Collaborator

National Institutes of Health (NIH)

Collaborator