Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04245852 |
| Other study ID # |
2020-0007 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 11, 2020 |
| Est. completion date |
November 16, 2020 |
Study information
| Verified date |
December 2020 |
| Source |
University of Illinois at Chicago |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
• Patients receiving physical therapy (PT) at the University of Illinois at Chicago Faculty
Practice (UICFP) meeting inclusion and exclusion criteria will be randomly assigned to one of
two groups: control group (CG) receiving standard care and an experimental group (EG)
receiving standard care in addition to being provided a strength education video (SEV). The
SEV is a short video designed to provide instructions clarifying how to do strength-based
exercises by monitoring a fatigue response with a set of any exercise. The EG will watch the
video with headphones in the waiting room of the UICFP on an iPad. The EG will also be
provided a handout with a link and QR code to the video on YouTube.com. Functional changes
with PT will be tracked for both groups using a Patient Specific Functional Scale (PSFS)
questionnaire at initial evaluation, follow up at session 3 or 4, and at any date of
anticipated discharge. Basic demographic data (age, sex), dates of data collection, and any
discharge dates will be tracked as well. If questions arise regarding the content of the SEV
then the treating physical therapist will be permitted to answer and apply the content at
their discretion. All therapists will have pre-approved the content of the video to ensure
there are no contradictions to their usual methods of care. Data will be gathered for up to 3
months.
Description:
- Human subjects for the study will be recruited and participate in the study at the
University of Illinois at Chicago Faculty Practice (UICFP) located at 1640 West
Roosevelt Road, 3rd floor, Chicago IL. All of the treating physical therapists with the
exception of Daniel Robinson will be participating as treating physical therapists in
this study and will therefore be aware of the proceedings involved. The treating
physical therapists: Aaron Keil, Brian Baranyi, Justin Payette, Deborah Davey, Benjamin
Land, Richelle Caya, Amanda Montbriand, Adam Wielechowski will be screening and
obtaining informed consent from study participants. Additionally, Jessica Pop will be
assisting in data collection and organization of data for the study.
- Patients receiving physical therapy (PT) at the UICFP will be screened for eligibility
according to inclusion and exclusion criteria by treating physical therapists including
obtaining consent to participate in the study at date of initial physical therapy
evaluation or before the patient leaves from the second follow up visit.
- Checking for inclusion and exclusion criteria will be referenced by the treating
therapist from the "Patient Checklist Data Form" (PCDF)
- If a patient does not meet any of the inclusion criteria or meets one of the
exclusion criteria they will be excluded from the study.
- If a patient is being added in the above manner on a date past initial evaluation
the physical therapist must record previous data needed that is available from
patient records (date of evaluation, Patient Specific Functional Scale (PSFS)
average score). The PSFS will be provided to all possible candidates in the clinic
as part of the standard intake paperwork. Therefore, the PSFS should still be
available for data after obtaining consent.
- Upon passing exclusion and inclusion criteria and obtaining informed consent,
patients will be randomized into either the control or experimental group. Only
after these setup steps will the PCDF be filled out and, if appropriate, provide
the Strength Education Video (SEV) for viewing.
o Once included into the study subjects will be randomly assigned to one of two
groups: control group (CG) or experimental group (EG).
- CG will receive standard PT care
- EG will receive standard care in addition to being provided a SEV.
- The SEV must be watched by the patient at the UICFP prior to leaving from the 3rd PT
visit.
- The EG will watch the video in the waiting room or other quiet available rooms on the
3rd floor within the UICFP.
- The video will be watched from an iPad/tablet/laptop/desktop computer device as
available in the clinic.
- The EG will also be provided a handout with a link and QR code to the video on
YouTube.com and disclaimer from the consent form.
- Disclaimer quoted from consent form: "Please follow the link bellow to the video
hosted on YouTube.com. Please be aware that by viewing the video on YouTube.com you
are agreeing to YouTube and Google's terms and conditions. This will not be sharing
any of your protected health information held by the University of Illinois
Hospital system or the University of Illinois at Chicago. You are not obligated to
click on or view this link. It is intended as a helpful tool for your benefit.
Please reach out to your treating physical therapist with any questions or
concerns"
- Treating physical therapist will record the date of SEV viewing on the PCDF. - The
PCDF will be used to record patient information by the treating physical therapist
and have a study subject identification (ID) number added by either Daniel Robinson
or Jessica Pop when performing data entry described later in protocol.
- Subject information contained in the PCDF includes:
- Treating Physical Therapist
- Patient Name
- Medical Record Number
- Age
- Sex
- Subject ID code
- Which group subject is allocated to (Control or experimental)
- Inclusion criteria checklist
- Exclusion criteria checklist
- Date of evaluation
- Evaluation PSFS score
- Date of SEV viewing (if in EG)
- Session number of SEV viewing (if in EG)
- Follow up PSFS score
- Follow up session number
- Follow up date
- Discharge PSFS score
- Discharge session number
- Discharge date
- Secondary Discharge PSFS score
- Secondary Discharge Session number
- Secondary Discharge date
- Tertiary Discharge PSFS score
- Tertiary Discharge Session number
- Tertiary Discharge date
- Indication if patient was discharged early from PT or had an unplanned discharge
from PT.
- PCDF sheets will be kept with physical therapists when being used to gather data or in
the UICFP in a locked cabinet/drawer in the folder of the specific physical therapist
separate from standard treatment notes.
- Data from the PCDF will be entered without patient names into a Private Data Excel Sheet
(PDES). This spreadsheet will be kept in a Box Health Data Folder (BHDF) only available
to the study investigators (Daniel Robinson, Jessica Pop, and Brian Baranyi) using a
secure password containing at least: one uppercase letter, one lower case letter, one
number, one symbol, and at least 8 characters.
- Functional changes with PT will be tracked for both groups using a Patient Specific
Functional Scale (PSFS) questionnaire at initial evaluation, follow up at session 3 or 4
(evaluation not counting as a session), and at any date of anticipated discharge.
- The PSFS being utilized has been altered slightly from its original form for the purpose
of clarifying to patients that 10 is a high functional performance skill. This is being
done due to subjective reports from clinicians that patients commonly misread the
questionnaire selecting 10 as a score of low function based on pain being the common
question they receive. The changes made do not involve adding any new words or content
changes that would be expected to alter nature of answers.
- If questions arise regarding the content of the SEV then the treating physical
therapist will be permitted to answer and apply the content at their discretion.
All therapists will have pre-approved the content of the video to ensure there are
no contradictions to their usual methods of care. Data will be gathered for up to 3
months.
