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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
PPAL
DevicePPAL is a patented, motorized, height adjustable bedside commode with integrated transfer boards. PPAL incorporates a transfer board that moves up and down as the chair seat is raised or lowered so that the user can always perform a downhill transfer. This innovation will allow individuals with limited mobility who currently rely on caregiver assistance to transfer more independently.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: PPAL UserExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in fall efficacy with connection to toileting
We aim to determine whether the use of PPAL reduces fear of falling during toileting activities. To assess this, we will utilize the Fall Concerns Scale for individuals who use Wheelchairs and Scooters (FCS-WC/S). Items are scored on a scale of concern, with 1 being "Not at all concerned" and 4 being "Very Concerned". Scores can be analyzed from specific questions, or the questionnaire as a whole. For this result we will focus on the item specifically associated with getting on/off of a toilet or commode at home. A decrease in FCS-WC/S scores at the end of the study would indicate a reduction in fear of falling.
Time frame
Change from pre to post 6 week trialSecondary outcomes
1
Change in GG Self-Care score for Toilet Transfer
We aim to observe a change in the GG Self-Care score for toilet transfers, specifically an improvement in the individual's ability to safely get on and off a toilet or commode. This item is scored on a scale from 1 (Dependent: completely reliant on a caregiver) to 6 (Independent: no assistance required). An increase in this score would indicate improved functional independence.
Time frame
Change from pre to post 6 week trial2
System Usability Scale (SUS)
We aim to find that PPAL will have at minimum an acceptable level of usability at the end of the trial. The SUS consists of items rated on a scale of 1 (strongly disagree) to 5 (strongly agree), assessing the participants perceived usability of the system in several domain areas. A total score is computed and a score of 68 or higher would be indicative of acceptable usability (scores ranging from 0 to 100 with higher scores indicating better usability).
Time frame
At the end of the 6 week trialSponsors and contacts
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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
Source ClinicalTrials.gov