Does a Video-based Education Tool Related to Strengthening Result in Different Functional Outcomes Compared to Traditional Physical Therapy Education for Patients?
NCT ID: NCT04245852
Last Updated: 2020-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2020-02-11
2020-11-16
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
Experimental group will receive standard physical therapy care in addition to being provided a strength education video.
Strength education video
The Strength education video must be watched by the patient at the University of Illinois at Chicago Faculty Practice (UICFP) prior to leaving from the 3rd physical therapy visit. The Experimental Group (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 quick response code to the video on YouTube.com
standard PT care
standard PT care
Control Group
The control group will receive standard physical therapy care at the University of Illinois at Chicago Faculty Practice.
standard PT care
standard PT care
Interventions
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Strength education video
The Strength education video must be watched by the patient at the University of Illinois at Chicago Faculty Practice (UICFP) prior to leaving from the 3rd physical therapy visit. The Experimental Group (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 quick response code to the video on YouTube.com
standard PT care
standard PT care
Eligibility Criteria
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Inclusion Criteria
* Strength training is a component of the intervention plan for physical therapy
* Strength training is being defined as any exercise aimed at improving the force production, speed, and ability of a muscle group or group of muscles by using body weight, resistance bands/cords, free weights, medicine balls, weight machines or similar equipment.
Patient consents to be part of the study prior to leaving from 3rd physical therapy (PT) clinic visit (Eval +2 sessions)
* Age 18 or older
* Has been provided a PSFS on date of initial PT evaluation
Exclusion Criteria
* Cancer, Fibromyalgia, Polymyositis, muscular dystrophy, Lupus, Multiple Sclerosis, Parkinson's, or any other progressive/degenerative muscle/nervous system condition, Rheumatoid arthritis
* Cognitive/psychological disorder limiting ability to comprehend educational video
* Dementia etc.
* English not preferred language
18 Years
ALL
No
Sponsors
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University of Illinois at Chicago
OTHER
Responsible Party
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Brian Thomas Baranyi
Clinical Assistant Professor
Locations
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University of Illinois at Chicago Physical Therapy Faculty Practice
Chicago, Illinois, United States
Countries
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Related Links
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Please see the strength education video for the experimental group
Other Identifiers
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2020-0007
Identifier Type: -
Identifier Source: org_study_id