Evaluation of the PPAL

Alicia Koontz

Status

Enrolling

Conditions

Age Problems

Treatments

Device: PPAL

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07221552

STUDY25100178

5R44NR019516-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This research study is being done 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 the user to assist with their own transfers to/from bed or chair to the PPAL for toileting, with little manual help provided by user's caregivers. Users who require assistance with transfers and their caregivers have a high likelihood of experiencing and 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 in a 6-week at home trial. Participants will be asked to schedule a home visit with the research team to screen their home and ask questions and observe the participant's current transfer methods to their toilet/commode to ensure that they and the caregiver are an appropriate candidate 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 6-week trial, the study team will arrange a final study visit date 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 the caregiver to ask them about their satisfaction with device. This interview will be audio recorded.

This study involves minimal risks which are expected to occur infrequently. There is the possibility that the participant could obtain a scrape, bruise, cut or pinch injury as you will be working with a device that they are not familiar with. 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 your use of it to minimize this risk. There is a risk of breach of confidentiality as text messages and emails may not be encrypted or secure during their transmission or storage and it is possible they could be intercepted and used by others not associated with this study.

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

Enrollment

16 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Toileter Inclusion Criteria:

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
If sitting for longer than 2 minutes (with or without assistance), does not get dizzy or lightheaded - residence is able to accommodate the PPAL in the Bedroom or designated space.

Toileter Exclusion Criteria:

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.

Caregiver Inclusion Criteria:

Age 18 years or above
Formal/paid or informal/unpaid caregiver for the patient participant (toileter) who provides toileting assistance at least 3 days per week

Caregiver Exclusion Criteria:

-Physical limitations that prevent caregiver from manually assisting with PPAL transfer or from maneuvering the PPAL around the end-user's residence