Virtual Exercise Rehabilitation In-home Therapy: A Randomized Study (VERITAS)
Phase: NA
Conditions: Total Knee Replacement
Sponsor: Duke University

Virtual Exercise Rehabilitation In-home Therapy: A Randomized Study (VERITAS) 
NCT02914210 
Unique Protocol ID: 
Pro00074409 
Document Date: 
March 2, 2017

 
 
 
VERITAS 
 
 
 
 
 
Virtual Exercise Rehabilitation In-home Therapy: 
A Randomized Study 
 
 
 
Protocol  
 
 
 
Version 1.4 
March 2, 2017 
 
 
 
 
 
 
 
 
CONFIDENTIAL

VERITAS Protocol v1.4 
March 2, 2017 
 
Page 1 of 16 
Contents 
INVESTIGATOR AGREEMENT .................................................................... 1 
1. 
Background ..................................................................................... 2 
1.1. 
Rehabilitation for Total Knee Replacement .......................................................................2 
1.2. 
Integrating Technology into Post-surgical Joint Replacement Rehabilitation Care ..............2 
1.3. 
Rationale for VERITAS Randomized Controlled Trial ..........................................................2 
2. 
Study Aims ...................................................................................... 3 
3. 
Study Design .................................................................................... 3 
3.1.  General Overview ............................................................................................................3 
3.2.  Site Selection Criteria .......................................................................................................5 
3.3.  Patient Selection Criteria ..................................................................................................5 
3.3.1.  Inclusion Criteria .......................................................................................................... 5 
3.3.2.  Exclusion Criteria ......................................................................................................... 5 
3.4 
Study Arms ......................................................................................................................5 
3.4.1 
Tele-rehab (Intervention) Group ................................................................................. 5 
3.4.2 
Traditional PT (Control) Group .................................................................................... 6 
3.5 
Patient-Reported Outcomes .............................................................................................6 
3.6 
Data Collection Methods ..................................................................................................7 
3.6.1 
Screening Log ............................................................................................................... 7 
3.6.2 
DCRI Registry System ................................................................................................... 7 
3.6.3 
DCRI Call Center ........................................................................................................... 7 
4.  
Study Procedures ............................................................................. 8 
4.1. 
Screening and Informed Consent ......................................................................................8 
4.2.  Baseline ...........................................................................................................................9 
4.2.1 
Randomization .............................................................. Error! Bookmark not defined. 
4.2.2 
Patient Contact Form and Medical Record Release ................................................... 9 
4.2.3  Patient-Reported Baseline Assessments .................................................................. 10 
4.2.4 
Baseline Case Report Form ........................................................................................ 10 
4.2.5  Patient Diary .............................................................................................................. 10 
4.3 
Surgical Hospitalization and Discharge .......................................................................... 111 
4.4 
6 Weeks Post-Op............................................................................................................ 11 
4.5 
12 Weeks Post-Op ........................................................................................................ 122 
5. 
Statistical Methods ....................................................................... 122 

VERITAS Protocol v1.4 
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5.1.  Sample Size.................................................................................................................... 12 
5.2.  Data Analyses ................................................................................................................ 13 
5.3.  Data Quality Assurance .................................................................................................. 14 
6.  
Ethical Considerations and Trial Oversight ..................................... 14 
6.1.  Ethical Considerations .................................................................................................... 14 
6.2.  Trial Oversight ............................................................................................................... 14 
6.3.  Trial Leadership ........................................................................................................... 155 
7.  
Administrative Requirements ....................................................... 155 
7.1.  Study Completion ........................................................................................................ 155 
7.2 
Adverse Experience Reporting ...................................................................................... 155 
7.3.  Source Documentation ................................................................................................... 15 
7.4 
Patient Reimbursement ................................................................................................. 15 
7.6.  Record Retention ........................................................................................................... 15 
8.  
References .................................................................................... 16 
 

VERITAS Protocol v1.4 
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Page 1 of 16 
INVESTIGATOR AGREEMENT 
 
I have read the VERITAS study protocol version 1.4 (March 2, 2017), including all appendices, 
and I agree that it contains all necessary details for my staff and me to conduct this protocol as 
described.  I will personally oversee protocol conduct as outlined herein. 
 
I will provide all study personnel under my supervision with copies of the protocol and access to 
all information provided by DCRI or the sponsor.  I will discuss this material with personnel to 
ensure that they are fully informed about the conduct of the protocol and the information being 
collected from patients enrolled in the VERITAS study.  I am aware that, before commencement 
of this study at my clinical facility, the local (or central) institutional review board must approve 
this protocol.  I agree to make all reasonable efforts to adhere to the VERITAS study protocol. 
 
I, or my designee, agree to be present at all site visits and investigator meetings. In addition, I 
will ensure the presence of relevant study personnel under my supervision at these visits and 
meetings. 
 
I agree to provide all subjects with a signed copy of the informed consent form, as required by 
government and International Conference on Harmonization regulations.  I further agree to 
report to the DCRI any protocol deviations in accordance with the terms of this protocol, Good 
Clinical Practice Guidelines, and applicable regulatory requirements.  All information pertaining 
to the protocol shall be treated in a confidential manner. 
 
_________________________________ 
_____________________________ 
Principal Investigator Name (print) 
 
Signature 
 
_________________________________ 
 
Date 
 

VERITAS Protocol v1.4 
March 2, 2017 
 
Page 2 of 16 
1. 
Background 
 
1.1.  
Rehabilitation for Total Knee Replacement 
Physical therapy (PT) is an important component of care for patients who have total knee 
replacement (TKR) surgery.  The focus of this rehabilitative care is to promote mobilization and 
the achievement of functional goals.  A meta-analysis evaluating the effectiveness of post-
surgical PT in 18 randomized clinical trials for a total of 1,739 patients with primary TKR 
concluded that patients who received PT had improved physical function and decreased pain at 
3-4 months after hospital discharge, and the benefit extended to 6 months in some studies.1 In the 
United States, PT after hospital discharge is provided in rehabilitation facilities, in the home by 
home health therapists, and in community-based clinics.  Although widely supported as the 
standard of care with evidence of effectiveness, there is significant variation in what is provided, 
to whom, and for what duration.  Post-acute care including utilization of PT for joint replacement 
is the single largest driver in the variation of Medicare spending.2  
 
Gaps exist in the ability of PT to support all patients in need, including a projected nationwide 
shortage of therapists, few therapists available in underserved areas, and limited numbers of PT 
visits covered by insurance for those who have it.  These gaps make it necessary to develop other 
effective, low-cost and accessible options to help patients regain physical function after TKR, 
and improve pain and other patient-centered outcomes.  This randomized clinical trial will 
compare the costs and clinical effectiveness of traditional PT versus a technology-supported 
home-based PT rehabilitation program for patients with TKR.   
 
1.2.  
Integrating Technology into Post-surgical Joint Replacement Rehabilitation Care  
A growing body of scientific literature exists with respect to leveraging technology in support of 
various approaches to tele-rehabilitation, which can be an innovative way to deliver PT after 
TKR to increase access to care without additional patient risks.3-6 A Canadian study of tele-
rehabilitation providing PT in real-time via video and audio interaction between therapist and 
patient demonstrated non-inferiority of outcomes compared with traditional in-person PT after 
TKR.7 This was confirmed with a meta-analysis of tele-rehabilitation which also found patients 
were highly satisfied with the use of telerehabilitation.8 Remote guidance and supervision 
address issues with geographic access due to lack of availability or transportation.  However, the 
ratio of physical therapists to patients remains an issue, and total costs for care are likely similar 
once accounting for costs of technology and technological support.   
 
1.3. 
Rationale for VERITAS Randomized Controlled Trial  
The use of digital technology where the patient and therapist can interact both in real-time and 
asynchronously (e.g., patient completes recommended activities and therapist reviews 
performance at different times) can alleviate scheduling issues for both the therapists and 
patients, allowing therapists to potentially manage more patients (higher case load) and patients 
to follow recommendations and complete activities when most convenient.  Having the PT 
program entirely available to the patient via technology may be cost efficient for both the patient 
and health system as more therapy sessions could be completed by the patient on their own 
schedule, without co-pays, and requiring less real-time PT supervision over time.  The primary 
aim of this project is to determine if a technology-supported home-based PT rehabilitation 
program is a cost-saving approach and at least clinically equivalent to traditional PT. 
 

VERITAS Protocol v1.4 
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2. Study Aims 
The goals of this research study are the following: 
 
1. To compare the effects of tele-rehab-supported PT versus traditional home and/or 
clinic-based PT for TKR on 90-day health service use costs.   
Hypothesis (Superiority):  Patients who receive tele-rehab-supported PT will have 
lower total 90-day episode of care costs compared with patients in the traditional PT 
group. 
 
2. To compare tele-rehab-supported PT and traditional PT on patient-centered outcomes   
a. Effectiveness hypothesis (Non-Inferiority):  The tele-rehab intervention will be 
non-inferior to traditional PT at 6 weeks (differences between groups <5% for 
clinical and patient-reported outcomes) and 12 weeks (difference <5% patient-
reported outcomes).  
b. Safety hypothesis (Non-Inferiority):  The tele-rehab intervention will be non-
inferior to traditional PT at 12 weeks (pain, self-reported number of re-
hospitalizations and number of reported falls).  
 
3. To explore whether individual patient characteristics are associated with differential 
improvement from 6 to 12 weeks assessed by patient-reported outcomes. 
  
 
3. 
Study Design 
3.1.  
General Overview 
VERITAS (Virtual Exercise Rehabilitation In-home Therapy: A randomized Study) is a 
multicenter randomized clinical trial aimed at evaluating the costs and clinical effectiveness of 
technology-supported home-based PT compared with traditional PT in the home or clinic.  
Patients in both groups will be prescribed exercises by a physical therapist and this trial is 
focused on the delivery of the PT program: VERA™ in the home with virtual PT support 
compared with PT provided through traditional methods (e.g., home health, clinic, printed 
instructions).  This study will recruit approximately 6 practice groups to enroll 300 patients with 
unilateral TKR who are planned to return home after hospital discharge. 
  
This study will be undertaken only after the site’s Independent Ethics Committee (IEC) or 
Institutional Review Board (IRB) of record has given full approval of the final protocol, 
informed consent form, and applicable patient recruitment materials.  Site coordinators will also 
need to complete appropriate training on the protocol and data collection systems prior to being 
activated for enrollment.  Participating sites may begin screening patients upon written 
authorization from DCRI Coordinating Center staff. 
 
Once authorized to begin, sites will pre-screen patients scheduled for TKR for eligibility.  Those 
appearing to meet the inclusion criteria will be approached by the site coordinator and invited to 
participate.  Those who qualify and express interest will be scheduled to meet with the site 
coordinator when they come in for their pre-operative clinic visit.  If the pre-operative visit 
timing is not conducive to enrollment, the site coordinator may schedule a separate visit for 
enrollment purposes.  The baseline study visit will be completed at least 10 days prior to surgery.  
After informed consent is obtained, patients will complete the baseline assessments and be 

VERITAS Protocol v1.4 
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randomized to either tele-rehab supported PT or traditional PT.  Intervention group patients will 
have the tele-rehab system installed in their home prior to surgery, virtually meet the physical 
therapist, receive recommendations for a pre-operative exercise program (“prehab”), and 
continue the recommended tele-rehab PT program after hospital discharge until discharged by 
the physical therapist.  Control group patients will follow the clinical team’s recommendations 
for PT as organized and delivered in traditional care (home health, clinic, paper instructions). 
There are no differences in risk to patients between the two study arms.   
 
Data capture will occur at the following time points, and is detailed in Table 1 below: 
 Pre-enrollment:  Screening log (monthly submission) 
 Baseline (10 or more days prior to surgery):  Randomization form, patient contact 
information and medical record release, patient surveys, case report form 
 Hospital discharge:  Case report form 
 6 weeks after surgery:  Case report form, patient surveys and diary (collected by DCRI 
Call Center)  
 12 weeks after surgery:  Patient surveys and diary (collected by DCRI call center), chart 
review for service utilization (among select sites) 
 
Table 1:  Study Activities and Data Capture 
Activity 
Screening 
Enrollment / 
Baseline 
D/C 
6 weeks 
post-op 
12 weeks 
post-op 
Complete screening log for all patients 
X1 
 
 
 
 
Invite patient to participate via letter or other 
IRB-approved method 
X2 
X2 
 
 
 
RAPT score and living situation assessment 
X2 
X2 
 
 
 
Consent and randomization 
 
X3 
 
 
 
Medical record release, patient contact form 
 
X 
 
 
 
Gait speed measurement 
 
X4 
X4 
X4 
 
Range of motion measurement 
 
 
 
 
X4 
 
Data collection form entered in DCRI 
Registry System 
 
X 
X 
X 
 
Chart review for health resource use 
 
 
 
 
X 
Patient-reported health outcomes 
 
 
 
 
 
KOOS 
 
X5 
 
Call Ctr 
Call Ctr 
PROMIS Global Health 
 
X5 
 
 
Call Ctr 
Satisfaction with Physical Function 
 
X5 
 
 
Call Ctr 
Adherence to PT regimen 
 
 
 
Call Ctr 
Call Ctr 
Pain6 
 
 
X4,6 
Call Ctr6 
 
Falls 
 
X5  
(in prior 3m) 
X4 
Call Ctr 
Call Ctr 
Physical activity 
 
X5 
 
Call Ctr 
Call Ctr 
Healthcare encounters / service use 
 
X5  
(hosp. in prior 3m) 
 
Call Ctr 
(pt diary) 
Call Ctr 
(pt diary) 
Thoughts about tele-rehab system7 
 
 
 
 
Call Ctr 
1 Submitted monthly via email to DCRI Coordinating Center. 
2 Completed at either timepoint as approved by local IRB. 
 
3 If surgery date is unknown at time of consent, randomization may be delayed, but must occur no less than 10 days prior to  
   surgery. 
4 Results recorded in medical record and entered on data collection form in DCRI Registry System. 
5 BL assessments collected by study site and faxed to DCRI Call Center. 
6 Collected using pain scale from PROMIS survey when full PROMIS is not administered. 
7 Collected only among patients randomized to tele-rehab. 
 

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3.2.  
Site Selection Criteria 
Approximately 6 orthopedic surgical practice groups will be selected to enroll patients in the 
VERITAS clinical trial.  Sites will be identified and approached based on estimated surgery 
volume, and the availability of staff resources to support successful participation.  Site selection 
will be limited geographically to a 50-mile radius around the Durham-Chapel Hill 
Comprehensive Joint Replacement (CJR) bundle region to minimize the variation of in-hospital 
costs. Site start-up may be staged to allow for controlled run-in of the first patients at each site. 
 
3.3.  
Patient Selection Criteria 
3.3.1.  Inclusion Criteria 
Patients are eligible to be included in the trial if they meet the following criteria: 
 ≥ 18 years of age  
 Scheduled to have a non-traumatic TKR 
 Can be enrolled a minimum of 10 days prior to surgery (in-person visit) 
 Have a Risk Assessment and Prediction Tool (RAPT) score of ≥ 6 indicating 
expected discharge home after surgical hospitalization  
 
3.3.2.  Exclusion Criteria 
Patients are excluded if they meet any of the following criteria: 
 Unable or unwilling to provide informed consent, including but not 
limited to cognitive or language barriers (comprehension) 
 Scheduled for staged bilateral TKR 
 Living in a nursing home prior to surgery 
 
3.4 
Study Arms 
This study will enroll 150 patients into each of two groups, for a total enrollment of 300 
patients. 
 
3.4.1 Tele-rehab (Intervention) Group 
The tele-rehab PT-supported system for this study is the Virtual Exercise Rehabilitation 
Assistant (VERA™) system developed by Reflexion Health.  VERA™ is a cloud-based 
virtual tele-health system that functions using 3D motion tracking technology to measure 
motion, remotely monitor the effectiveness of a prescribed regimen, and provide detailed 
audible instructions and immediate feedback to patients on exercise quality.  A therapist 
or other healthcare provider issues a therapy regimen through the clinician interface, and 
the VERA™ system installed in the patient’s home delivers the therapy using interactive, 
motion-capturing technology and an avatar to demonstrate, track, and monitor the 
patient’s exercise performance.  Patients are able to view their own progress in the 
system and perform prescribed exercises and activities selected by the treating physical 
therapist.  Performance is remotely monitored either in real-time or asynchronously, and 
as in traditional PT, the program of activities can be revised by the physical therapist to 
best match the progress of the patient.  The therapist and patient can “meet” for virtual 
real-time appointments as needed.  The VERA™ system received FDA 510(k) clearance 
in October, 2015, and is available on the public market for purchase by healthcare 
providers.   
 

VERITAS Protocol v1.4 
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The coordinating center will organize VERA™ installation into patients’ homes for those 
randomized to the intervention group.  Participants will be contacted by staff of Reflexion 
Health to schedule installation after enrollment and prior to surgery.  After installation, 
the intervention patients will virtually meet with the physical therapist to begin prehab.  
All patients in the intervention arm will have their PT regimen designed and monitored 
by a study PT based in the Duke Department of PT/OT, using the remote clinician 
interface that is incorporated into the VERA™ platform.   
 
After the system is in the patient’s home and the patient has spoken with the study 
therapist, s/he will be encouraged to access the system to begin pre-operative activities 
and become familiar with the system.  Patients will be able to access the system as often 
as they like.  Participants who do not interact with the system during the first 7 days after 
installation will be contacted by the study therapist encouraging them to begin.  
 
Within 2 business days of hospital discharge, the study therapist will contact the patient 
to review the post-surgical PT program and recommend any changes to therapeutic 
activities or intensity.  Participants will be encouraged to be as active with the program as 
their abilities, health conditions, and pain allow. 
 
Patient progress will be monitored remotely by the study therapist.  If at any time the 
study therapist feels that the patient requires additional support to ensure the success of 
their post-discharge therapy, s/he may escalate the patient back to the orthopedic 
surgeon’s office for assessment.  This assessment may include the prescription of 
supplemental PT with one or more local, in-person visits, at the orthopedic surgeon’s 
discretion, to be completed in addition to continuing with in-home PT sessions via the 
tele-rehab platform.  A VERA™ progress report from the study therapist will be provided 
to the site coordinator to deliver to the surgeon ahead of the 6-week follow-up visit.  
Discharge from VERA™ will be determined by the study physical therapist. 
 
Patients will be given a telephone number to contact the Reflexion Health technical 
support team if they need technical support with VERA™.  These telephone contacts will 
not involve any program participation guidance in order to ensure validity of the study 
results.   
 
3.4.2 Traditional PT (Control) Group 
Patients randomized to traditional PT will complete care as usual.  This includes prehab 
as recommended by the participating site, in-hospital care, and home health or clinic-
based PT as directed by the clinical team.  There will be no restriction on the timing or 
number of PT encounters.  
 
3.5 
Patient-Reported Outcomes 
Both standardized and de novo instruments will be utilized to collect patient-reported 
information regarding health.  Domains of health data will include knee feeling and function, 
overall perception of his/her own health, activity level, pain, falls, and health service utilization.  
Assessments will be collected at multiple time points throughout the study, and include the 
following items: 

VERITAS Protocol v1.4 
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 Knee Injury and Osteoarthritis Outcome Score (KOOS)9 – pain, symptoms, 
activities of daily living, function in sports and recreation, and knee-related 
quality of life. 
 Patient-Reported Outcomes Measurement Information System (PROMIS) Global 
Health survey10 – outcomes and health-related quality of life. 
 Satisfaction with Physical Function questionnaire11 – satisfaction with ability to 
complete basic functional tasks. 
 Physical activity – frequency and duration of moderate activity/exercise. 
 Pain – scale from 0 (no pain) to 10 (worst pain imaginable). 
 Falls – number occurring since last contact. 
 Return to work – resumption of pre-injury working status 
 Health service utilization – healthcare encounters including office visits, phone 
calls and emails, and hospitalizations.  Captured with the aid of a patient diary 
tool (see section 4.2.5). 
 
3.6 
Data Collection Methods 
Three data collection methodologies will be used for this study:  an Excel spreadsheet to track 
patient screening, a web-based data capture system for use by site coordinators in chart 
abstraction, and a Call Center to perform patient follow-up interviews. 
 
3.6.1 Screening Log 
Sites will be provided a screening log in Excel format, on which they will record de-
identified information about all patients screened for potential inclusion in this study.  
The log will be maintained on an ongoing basis, and will be submitted to the DCRI 
Coordinating Center once per month, or ad hoc as requested by coordinating center staff.  
The log will serve to document how patients are included or excluded based on eligibility 
requirements, and whether eligible patients consent or decline to participate. 
 
3.6.2 DCRI Registry System 
The study will use a secure, password protected web-based electronic data collection tool 
(DCRI Registry System) for site coordinators to abstract medical record information 
about each patient after informed consent is obtained.  Collection time points include 
randomization, baseline (enrollment visit), hospital discharge, and 6 weeks after 
discharge.  Data are expected to be present in the patient’s medical record, either as 
standard of care or as documented for study purposes. 
 
Access to the data capture system is role-based, with each authorized person receiving a 
unique user ID and password with appropriate permissions.  Prior to being granted access 
to the system, site staff will be required to undergo appropriate training by the DCRI 
coordinating center. 
 
3.6.3 DCRI Call Center 
DCRI Call Center staff will contact all patients via telephone approximately 6 and 12 
weeks after discharge to administer the follow-up assessments and collect details from 
the patient diary.  The Call Center will attempt to contact patients using the information 
provided on the patient contact form at the time of consent.  Additionally, the Call Center 

VERITAS Protocol v1.4 
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provides a toll-free number for patients to use to either complete their follow-up 
interviews, or to schedule their interviews at a convenient time.  The Call Center is 
staffed days, nights, and weekends to facilitate a high completion rate.  Interviewers 
receive standardized training in data collection, and follow a prepared script to minimize 
variation and missing variables. 
 
 
4.  
Study Procedures 
4.1. 
Screening and Informed Consent 
After obtaining written authorization from the DCRI Coordinating Center that study activities 
may begin, the site coordinator will review participating surgeons’ schedules for adult patients 
(age ≥ 18) scheduled for TKR at least 10 days into the future. Whenever possible, potentially 
eligible patients will be introduced to the study with a letter mailed to their homes in advance of 
their pre-op visit.  The study coordinator may then complete a follow-up phone call to those 
patients to assess interest, and complete the pre-screening assessment of RAPT score and living 
situation (not in a nursing home).  If the patient qualifies and is interested, he or she will be 
asked to meet with study staff during his/her regular pre-op visit to further discuss the study, and 
be enrolled if he/she agrees. 
 
It is expected that enrollment (consent, medical record release, and patient contact information) 
and baseline data collection (surveys) will be completed concurrently with the routine pre-op 
visit.  If this is not possible, a separate study visit can be scheduled for this purpose.  
Additionally, patients who are unable to be contacted prior to their pre-op visit, but still able to 
meet the requirement for enrollment at least 10 days prior to surgery, may have their interest 
assessment, screening, and enrollment all completed at the pre-op visit, or at a separate study 
visit.  Patients whose surgery dates have not been finalized at the time of the enrollment visit 
may be enrolled, but should not be randomized until the surgery date is scheduled.  Sites should 
not submit baseline enrollment materials (signed consent, medical record release, contact form, 
and baseline survey) to the DCRI Coordinating Center until randomization occurs.  
 
Regardless of timing for the interest assessment, screening procedures, and randomization, all 
enrollment, baseline data collection, and randomization activities must be completed at least 10 
days prior to the patient’s surgery date.  Otherwise, the patient will be considered ineligible. 
 
Information regarding all screened patients will be documented on a study screening log 
(spreadsheet) and submitted to the DCRI Coordinating Center on a monthly basis via email.  The 
log will contain de-identified information regarding all patients who were screened, were 
excluded (RAPT < 6, nursing home resident, scheduled for bilateral TKR, unable to consent, 
unable to enroll at least 10 days prior to surgery), declined to participate, or were enrolled. 
 
Each patient who agrees to participate must provide written consent in person, prior to 
completing any study activities.  The informed consent explains to potential patients the study 
aims, procedures, and any potential risks.  Patients will be informed that their participation is 
voluntary and that they may withdraw consent to participate at any time without affecting their 
care in any way.  They will be given sufficient time to review the informed consent document, 
discuss the consent with the investigator or an authorized member of the investigational staff, ask 
any additional questions, and record consent by means of their dated signature.  The patient will 

VERITAS Protocol v1.4 
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receive a copy of the signed consent form.  Only the patient is authorized to provide written 
informed consent, unless an alternative consent method (e.g., a legally authorized representative) 
has been approved in advance by the DCRI Coordinating Center and the study site’s IRB of 
record.  
 
A copy of the signed informed consent will be faxed to the DCRI Call Center within 1 business 
day of randomization.  The original signed paper document will be retained by the site and stored 
in a secure location, according to the site’s IRB-approved procedures. 
 
4.2.  
Baseline  
The following procedures will be completed at the enrollment/baseline study visit, which will be 
performed during the routine pre-op visit whenever possible.  All baseline activities must be 
completed no less than 10 days prior to the patient’s surgery date.   
 
4.2.1 Randomization 
After providing written informed consent, patients will be randomized to either 
traditional PT or the tele-rehab platform for PT.  Site coordinators will obtain the 
patient’s assignment by completing a short randomization form in the DCRI Registry 
System.  After saving the form with a Complete status, the system will return a 
randomization result.  The coordinator will note this information in the patient’s study 
record, as it will be required in order to manage the patient’s discharge orders for 
traditional PT services versus the tele-rehab system.  Randomization assignment will also 
be recorded on the baseline DCF. 
 
If the patient’s surgery date is known at the time of the enrollment/baseline visit, 
randomization may be completed during the visit, before or after collection of the patient 
contact form, medical record release, and patient-reported baseline assessments (see 
sections 4.2.2 and 4.2.3 below).   
 
If a patient’s surgery date is not known at the time of the enrollment/baseline visit, the 
patient contact form, medical record release, and patient-reported baseline assessments 
may still be completed, but randomization should be postponed.  All documents should 
be held at the site until a surgery date is selected, at which time randomization may occur 
and documents may be submitted to the DCRI Call Center.   
 
In either case, randomization must occur no less than 10 days prior to the patient’s 
surgery date, or the patient will be considered ineligible. 
   
4.2.2 Patient Contact Form and Medical Record Release 
After signing the consent, patients will be asked to complete a contact form providing 
their address, phone number, and email address, as well as the best time to reach them.  
They will also be asked to provide this information for alternate contacts, at least one of 
which is not related to them.  This information will be used to facilitate the 6- and 12-
week follow-up phone calls by the DCRI Call Center.  Additionally, a medical record 
release form will be collected for use in the event that the DCRI Coordinating Center 
needs to collect medical records or bills for the 12-weeks health service utilization 
assessment.   

VERITAS Protocol v1.4 
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Copies of the completed patient contact form and medical record release form will be 
faxed to the DCRI Call Center within 1 business day of randomization.  If a patient’s 
surgery date is unknown at the time of consent, a patient contact form and medical record 
release may still be completed, but randomization should be postponed.  All documents 
should be held at the site until a surgery date is selected, at which time randomization 
may occur and documents may be submitted to the DCRI Call Center.  The original 
documents will be retained by the site and stored either on paper or electronically in a 
secure location, according to the site’s IRB-approved procedures. 
 
4.2.3   Patient-Reported Baseline Assessments 
Each patient will complete following assessments at baseline, during the pre-op visit or 
study enrollment visit.  These assessments must be completed at least 10 days prior to the 
patient’s surgery date: 
 Surveys regarding health (KOOS, PROMIS Global Health, Satisfaction with 
Physical Function Scale) 
 Physical activity 
 Falls and hospitalizations in the prior 3 months 
 Comfort with using technology 
 Self-selected personal goal for recovery 
 
Copies of the completed patient-reported baseline assessments will be faxed to the DCRI 
Call Center within 1 business day of randomization.  If a patient’s surgery date is 
unknown at the time of consent, baseline assessments may still be completed, but 
randomization should be postponed.  All documents should be held at the site until a 
surgery date is selected, at which time randomization may occur and documents may be 
submitted to the DCRI Call Center.  The original documents will be retained by the site 
and stored either on paper or electronically in a secure location, according to the site’s 
IRB-approved procedures. 
 
4.2.4 Baseline Case Report Form 
The following patient data will be collected: 
 Socio-demographic information 
 Medical history and comorbidities 
 Vital signs (heart rate, blood pressure, 10m gait speed) including height and 
weight 
 
4.2.5  Patient Diary 
Sites will be provided copies of a diary form to be given to each patient after randomization, as a 
method to support recall of healthcare interactions during the 6- and 12-week follow-up 
interviews.  Patients will be instructed to use the diary to collect any interactions with the 
healthcare system that occur after they are discharged from the hospital following their surgery.  
Encounters of interest will include in-person PT visits, doctor visits, phone calls or emails to a 
PT or doctor, visits to an urgent care center or emergency room, and hospitalizations.  Patients 
will also be instructed to rate weekly (on Sunday) their level of achievement of their self-selected 

VERITAS Protocol v1.4 
March 2, 2017 
 
Page 11 of 16 
personal recovery goal.  Data recorded on the diary will be collected from the patient verbally by 
the DCRI Call Center during the planned follow-up interviews. 
 
4.3 
Surgical Hospitalization and Discharge 
Within two days of the scheduled surgery date, site coordinators will confirm the dates of 
admission and surgery, and enter these in the DCRI Registry System on the discharge data 
collection form.  This will enable the DCRI Coordinating Center to confirm follow-up by the 
study therapist for intervention patients, and timing of outcome assessments for all patients. 
When confirming admission and surgical dates, the site coordinator also should confirm the 
expected discharge plan for all study patients to be a discharge home, and coordinate with 
hospital discharge planners to ensure that intervention patients are not referred to home health or 
outpatient PT.  
 
Prior to hospital discharge, patients will be assessed for gait speed, pain, and falls during the 
hospitalization.  While these are standard physical assessments, site coordinators may need to 
coordinate collection of these in-hospital data with the hospital team and inpatient physical 
therapist, to ensure they are captured for all study patients.  The study coordinator is expected to 
enter these data on the discharge data collection form in the DCRI Registry System within 3 
calendar days of hospital discharge.  DCRI may also send an email to study staff within 1 
business day of the original surgery date to confirm whether or not the surgery occurred. 
 
Study staff should also coordinate with hospital staff, or develop an alternate method, to remind 
patients to begin completing their diary of healthcare encounters after discharge. 
 
4.4 
6 Weeks Post-Op  
Standard clinical follow-up for TKR patients occurs approximately 6 weeks after surgery.  At 
this routine visit, patients will be administered standard assessments for gait speed and range of 
motion (ROM) in the operated knee.  Study coordinators may need to coordinate with the clinic 
team to ensure these data are documented consistently in the medical record. 
 
The study coordinator is expected to enter these data on the 6-week data collection form in the 
DCRI Registry System within 14 calendar days of the visit. 
 
At approximately 6 weeks after surgery, the patient will also be contacted by the DCRI Call 
Center to collect the following data via telephone interview.  The interview is expected to last 
20-30 minutes: 
 Survey regarding health (KOOS) 
 Adherence to prescribed PT regimen 
 Pain  
 Physical activity  
 Falls since hospital discharge 
 Healthcare encounters since hospital discharge, and weekly status of personal recovery 
goal (patient diary entries) 
 

VERITAS Protocol v1.4 
March 2, 2017 
 
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4.5 
12 Weeks Post-Op  
At approximately 12 weeks after surgery, the patient will be contacted again by the DCRI Call 
Center to collect the following data via telephone interview.  The interview is expected to last 
approximately 20 minutes: 
 Surveys regarding health (KOOS, PROMIS, Satisfaction with Physical Function) 
 Adherence to prescribed PT regimen 
 Physical activity  
 Falls since last interview 
 Healthcare encounters since last interview, and weekly status of personal recovery goal 
(patient diary entries) 
 Thoughts about the tele-rehab platform (intervention patients only) 
 
Also at 12 weeks after surgery, select sites may be asked to provide a summary of enrolled 
patients’ outpatient clinic encounters (phone, email, in person) with orthopedic staff and physical 
therapists.  This may be used to validate patient-reported encounters from the diary.  Collection 
of the information, if requested, may be facilitated using the medical record release form signed 
by the patient at the time of enrollment. 
 
 
5. 
Statistical Methods 
The goal of this study is to assess the cost of the episode of care for total knee replacement, and 
whether the use of a tele-rehab platform is successful in mitigating some of those costs.  The 
episode for analysis will be from surgery through 3 months post-discharge, in alignment with the 
new Comprehensive Care for Joint Replacement (CJR) bundled payment model being piloted by 
the Centers for Medicare and Medicaid Services (CMS).  This will be a time-driven activity-
based cost (TDABC) analysis.  DCRI will be responsible for regular reporting of enrollment 
statistics, data quality, and data query status to the sponsor. 
 
In addition to assessing the primary objective of cost, the study also will assess standard clinical 
measures of recovery (range of motion, gait speed) and qualitative measures of patient 
perceptions regarding their health and functional status (patient surveys) using both standardized 
and non-standardized tools.  These assessments are intended to demonstrate the non-inferiority 
hypothesis that patients receiving PT via the tele-rehab platform did not have worse outcomes 
than patients receiving traditional in-person PT. 
 
5.1.  
Sample Size  
The primary aim of this study is to assess the difference in outpatient post-surgical costs between 
the control and intervention groups.  The exact post-procedure cost estimates under study are 
unknown; however, we can estimate that an effect size of approximately 0.33 can be detected 
with 150 subjects per group with at least 80% power.  The effect size is the ratio of the mean 
difference over the standard deviation (SD) assumed for each population, while the coefficient of 
variation (CV) is the ratio of the population mean over the SD.  Lower variability would enable 
detection of a smaller cost difference, or the detection of a larger difference with fewer patients.  
The below table gives several mean ratios that could be detected with 80% power and 300 
subjects where R1 is the ratio of the means (Control / Intervention) at which the power is 
calculated using a two-sample t-test with equal variance and a significance level of 0.05.   

VERITAS Protocol v1.4 
March 2, 2017 
 
Page 13 of 16 
 
 
 
 
 
 
Effect 
 
 
Power 
N1 
N2 
N 
R0 
R1 
Size 
CV 
Alpha 
0.8023 
150 
150 
300 
1.000 
1.033 
0.3255 
0.1 
0.050 
0.8070 
150 
150 
300 
1.000 
1.067 
0.3275 
0.2 
0.050 
0.8003 
150 
150 
300 
1.000 
1.100 
0.3247 
0.3 
0.050 
0.8045 
150 
150 
300 
1.000 
1.134 
0.3264 
0.4 
0.050 
0.8184 
150 
150 
300 
1.000 
1.170 
0.3324 
0.5 
0.050 
0.8101 
150 
150 
300 
1.000 
1.200 
0.3288 
0.6 
0.050 
0.8078 
150 
150 
300 
1.000 
1.230 
0.3278 
0.7 
0.050 
0.8096 
150 
150 
300 
1.000 
1.260 
0.3286 
0.8 
0.050 
0.8143 
150 
150 
300 
1.000 
1.290 
0.3306 
0.9 
0.050 
0.8209 
150 
150 
300 
1.000 
1.320 
0.3335 
1.0 
0.050 
0.8098 
150 
150 
300 
1.000 
1.340 
0.3287 
1.1 
0.050 
0.8025 
150 
150 
300 
1.000 
1.360 
0.3256 
1.2 
0.050 
0.8153 
150 
150 
300 
1.000 
1.390 
0.3310 
1.3 
0.050 
0.8125 
150 
150 
300 
1.000 
1.410 
0.3298 
1.4 
0.050 
0.8116 
150 
150 
300 
1.000 
1.430 
0.3295 
1.5 
0.050 
0.8123 
150 
150 
300 
1.000 
1.450 
0.3297 
1.6 
0.050 
0.8004 
150 
150 
300 
1.000 
1.460 
0.3247 
1.7 
0.050 
0.8039 
150 
150 
300 
1.000 
1.480 
0.3262 
1.8 
0.050 
0.8082 
150 
150 
300 
1.000 
1.500 
0.3280 
1.9 
0.050 
0.8007 
150 
150 
300 
1.000 
1.510 
0.3248 
2.0 
0.050 
 
Thus, with 300 subjects we can detect an effect size of 0.33 which represents a whole scenario of 
cost differences that can be detected with at least 80% power that is dependent on the variability 
of the costs under study.  The below table illustrates some example cost differences that could be 
detected based on the assumed SD of the costs.   
Standard Deviation 
(SD) 
Mean Cost 
Difference ($) 
 
Standard Deviation 
(SD) 
Mean Cost 
Difference ($) 
100 
32.50 
 
800 
259.60 
200 
64.90 
 
900 
292.10 
300 
97.40 
 
1000 
324.50 
400 
129.80 
 
1100 
357.00 
500 
162.30 
 
1200 
389.50 
600 
194.70 
 
1300 
421.90 
700 
227.20 
 
1400 
454.40 
750 
243.40 
 
1500 
486.80 
 
If the mean cost difference expected is around $500, then the SD should be no more than $1500 
in order to maintain at least 80% power.  If the cost difference is around $200 then the SD would 
need to be no more than $600.  
 
5.2.  
Data Analyses 
Data will be analyzed as intent-to-treat, therefore all randomized patients will be included for 
analysis as randomized, regardless of whether or not they completed all protocol requirements.  
The exception will be if a patient withdraws consent to participation and requests in writing that 
all data previously collected be removed from the study. 

VERITAS Protocol v1.4 
March 2, 2017 
 
Page 14 of 16 
Baseline patient demographics, clinical characteristics, and outcomes assessed at each time point 
will be summarized overall and for each group.  Continuous variables will be summarized using 
the mean, SD, median, inner-quartile range (IQR) and range, while categorical variables will be 
presented using counts and percentages.  The primary cost comparisons will be done using a t-
test if data are normally distributed or can be normalized using a transformation such as the 
logarithm or square root, otherwise, the nonparametric Wilcoxon Rank sum test will be used.   
 
All analyses will be completed using SAS version 9.4 or higher, and a p-value < 0.05 will be 
considered statistically significant.  A detailed statistical analysis plans will be prepared prior to 
analyses. 
 
5.3.  
Data Quality Assurance 
Missing data fields will be queried upon initial entry into the web-based data collection tool.  In 
addition to instant queries, periodic data quality reports will be sent to each site via the web-
based data collection tool to permit entry of missing or incomplete data fields.  Sites may also be 
asked to respond to data clarification requests.  In the event that missing data are not reclaimed 
on query, each variable will be evaluated separately before each analysis. This evaluation is 
necessary to explore the reason for the missing data and to check for other known variables in 
the dataset that may predict why the data are missing. 
 
 
6.  
Ethical Considerations and Trial Oversight 
6.1.  
Ethical Considerations 
This trial will be submitted to an IEC or IRB (local or central) for approval. Minimum 
supporting documentation includes the final protocol, informed consent form, data collection 
forms, surveys and interview scripts, and applicable patient recruitment materials.  Progress 
reports will be submitted to IRBs and regulatory authorities as required by local laws and 
regulations.  This trial will be conducted in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki and are consistent with good clinical practices and 
applicable laws and regulations of the institution where the trial is being conducted, as 
appropriate.  
 
As part of local IRB submission for the study, sites will be expected to outline their proposed 
methods and timeline for completing procedures to assess patient interest and pre-screen for 
eligibility.  Sites also will be expected to obtain IRB approval for verbally consenting the patient 
before completing the RAPT score assessment in order to determine eligibility.  
 
The patient will provide authorization for the uses and disclosure of their personal health 
information as described in the informed consent form. The confidential nature of the patient 
information will be maintained.  
 
6.2.  
Trial Oversight 
Trial operation management and scientific oversight for VERITAS will be performed by Duke 
Clinical Research Institute (DCRI).  Sites will be provided with both telephone numbers and 
email addresses, as appropriate, to contact the DCRI study team for assistance, which generally 
will be available from 8 am – 5 pm Eastern Time Monday through Friday, excluding holidays.  

VERITAS Protocol v1.4 
March 2, 2017 
 
Page 15 of 16 
Throughout the study, DCRI will maintain records of all issues and resolutions when a site is 
assisted.   
 
6.3.  
Trial Leadership 
Duke University and Duke Clinical Research Institute (DCRI), along with the sponsor, Reflexion 
Inc., will be responsible for VERITAS design, implementation, and leadership.  Data analysis 
and publications will be managed according to a written plan designed to maintain appropriate 
scientific oversight and rigor.   
 
 
7.  
Administrative Requirements 
7.1.  
Study Completion 
Study enrollment will continue until 300 patients have been enrolled.  Enrollment is anticipated 
to last approximately 10 months. The study will be considered complete upon completion of all 
study-related procedures (data collection) for the last patient enrolled.  
 
7.2 
Adverse Experience Reporting 
Reporting of any adverse experiences discovered during the course of the study will be the 
responsibility of care providers at the site, and should be made using the appropriate mechanism 
(e.g., FDA Medwatch). 
 
7.3.  
Source Documentation 
At a minimum, source documentation must be available to substantiate patient identification, 
eligibility, participation, and proper informed consent procedures.  Specific items required as 
source documents will be reviewed with the investigator before the study. 
 
7.4 
Patient Reimbursement 
Patients will be reimbursed for their time in participating in this study, based on completion of 
study benchmarks.  Funds for patient reimbursement will be provided to participating sites, who 
in turn will issue reimbursement directly to their enrolled patients, as appropriate.  Details of the 
reimbursement schedule and requirements will be detailed in the site-specific informed consent 
document.  
 
7.6.  
Record Retention 
Because this study is comparing two approved methods for delivering standard post-surgical PT, 
sites will not receive on-site monitoring visit(s) for this study. However, the investigator/ 
institution will maintain all source documents that support the data collected regarding each 
patient, as well as all study documents as specified by the applicable regulatory requirement(s). 
If the responsible investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility.  DCRI must be notified in writing of the name and address of the new 
custodian.  If it becomes necessary for the sponsor or the appropriate regulatory authority to 
review any documentation relating to this study, the investigator must permit access to all study 
documentation. 
 
 

VERITAS Protocol v1.4 
March 2, 2017 
 
Page 16 of 16 
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2. Mechanic R. Post-acute care--the next frontier for controlling Medicare spending. N 
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8. Shukla H, Nair SR, Thakker D. Role of telerehabilitation in patients following total 
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