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Case Study: TrialMax Slate® Reduces Site Burden Conducting 6-Minute Walk Test
CRF Health recently migrated the 6-Minute Walk Test (6MWT) assessment from paper to eCOA to collect clinical trial data for a rare, incurable disease affecting the heart. TrialMax Slate® and TrialManager® were used to reduce burden on sites, streamlining their workflow and bundling materials traditionally used during a 6MWT in one, easy-to-use tablet for seamlessly organized data collection.
Case Study: TrialMax Slate® Reduces Site Burden Conducting 6-Minute Walk Test
Reduces Site Burden
The 6MWT required many elements outside of a simple question and answer format, which made using paper less than ideal. Let's take a deeper
look at some of the challenges study teams faced using paper for the 6MWT assessment.
In a recent study, a site-based eCOA solution, including one Performance Outcome (PerfO) and three Patient-Reported Outcomes (PROs), was
used to evaluate treatment for a rare, incurable disease aﬀecting the heart.
Sites participating in this study had many responsibilities, which ranged from ensuring subjects complete the questionnaires, setting up the PerfO
(a 6-Minute Walk Test (6MWT) assessment) so that the assessment was executed properly, guaranteeing consistency between the subjects, and
securing good quality data. But all of this was very diﬀicult to do with paper.
6-Minute Walk Test (6MWT) Overview
However, the paper-based 6MWT created diﬀiculties for study teams.
Challenges with Paper
The 6-Minute Walk Test (6MWT) assessment is a measure of how far a
subject can walk in 6 minutes. Its main purpose is to evaluate a subject's
physical ability and endurance. The test is often used in the following
Chronic Obstructive Pulmonary Disease (COPD)
Peripheral Vascular Disease
… And More
Balancing the multiple tools that were required to perform
the 6MWT successfully took careful consideration and
methodical planning ahead of the assessment. A countdown
timer, lap counter, worksheet/clipboard, and writing utensil
were all necessary to accurately capture the results of each
subject's test. As you can imagine, balancing the countdown
timer and lap counter alone presents a challenge. Ensuring
two diﬀerent tools are turned on and working at the right time
made it diﬀicult for study teams. And with patients that are
already very sick, getting the data right the first time was
Additionally, there were three questionnaires that subjects
needed to answer before completing the 6MWT, so it was
important to separate subject and site staﬀ logins to
distinguish sections and responses for easier clarification and
Because the 6MWT requires careful explanation to subjects so that they fully understand the assessment, it was important that the 6MWT include
clear instructional text for sites to properly explain tasks. Ample space to record the data following site instruction was also needed to avoid messy
data such as information in the margins or missed or ignored sessions, which jeopardized data quality.
Paper also made it very diﬀicult for study teams to analyze and report subject performance data, especially in real-time. Evaluating a subject
requires compiling the paper forms, summarizing the data onto a new form, accounting for new entries as they are submitted, and then calculating
the results by hand. This allowed lots of room for error.
Finally, because the results of the test needed to be available shortly after the test was done (at screening visits), this type of time pressure on sites
also lead to errors for study teams.
CRF Health was the chosen eCOA provider during this 6MWT study due to its experience with migrating challenging questionnaires to an electronic
modality. Transferring the 6MWT from paper to eCOA required functionality that allowed the clinician to focus on the subject, while still acquiring
the subject's data.
The following custom features were created to make the entire process easy for sites and subjects:
A digital lap counter that made it easy for site staﬀ to count laps using one device instead of multiple tools
An alert built into the digital lap counter that sounded after noting that a subject successfully completed a lap, making it obvious for
everyone to know when one was achieved
Easy-to-read instructional text that helped the sites explain exactly what the subjects needed to do and how to do it, eliminating the risk of
errors and confused subjects (instructions were also directed at staﬀ to assist them in being able to perform the test appropriately)
A digital diagram of the course to assist the sites in correctly recording the distance walked by subjects
Site-Based Tablet Devices
Online Web Portal
Following receipt of the TrialMax Slate tablet devices, sites were tasked
with setting up subjects and activating three (3) questionnaires. These
questionnaires collected basic health, heart, and neuropathy data prior
to the 6MWT. Following their completion of the questionnaires, sites
administered the 6MWT and subjects walked the course. The subject's
goal was simply to walk as many laps as they could. If they needed to
take breaks, they could, but the clock continued to run to accurately
measure their ability to walk for 6 minutes.
After evaluating subject data, sites transmitted the data wirelessly to
TrialManager, CRF Health's online portal for exploring and reviewing
data collected from all TrialMax modalities.
Simple, easy to follow instructional text tells the 6MWT
administrator exactly what to say to the subject and when to say
it. A lap counter at the bottom of the screen made it easy to add
or remove laps using the + and - keys.
Instructional text for site staﬀ made it easy to know if proper
instructions were dictated to subjects. Sites selected “Yes” or
“No” next to each prompt, making it clear which instructions
were given, and, if any, which were not.
Implementing TrialMax Slate®
for Seamless Data Capture
Paper made it very diﬀicult for study teams to analyze and report subject performance data, especially in real-time. TrialManager was the answer to
TrialManager provides real-time access to subject data and compliance metrics for site staﬀ and study teams. It contains tailored reports based on
the data collected in all TrialMax modalities. Reports support real-time data management, oversight of study data, and trial monitoring.
Aside from the standard reports that provided subject, site staﬀ, and data management insights, CRF Health also created a customized 6MWT
report, used for reviewing all aspects of the 6MWT including the dates all assessments took place, the diﬀerence in distance walked for a test and its
predecessor, and the baseline distances recorded for a subject. This allowed sites to monitor subjects' conditions throughout the course of the
By migrating the 6MWT from paper to the TrialMax eCOA platform, site staﬀ focused on the subjects' needs, ensuring they understood what was
expected of them during the 6MWT. Also beneficial on this study was the ability to collate and evaluate the data in real-time and send it to
TrialManager, where the data was immediately available for review by a secondary party that assured the test's accuracy. Finally, providing site staﬀ
with an easier solution that bundled the materials they traditionally use in one simple, easy-to-use tablet streamlined the workflow for
easier, more organized data collection. All of these advanced features
improved data quality and therefore minimized regulatory risks.
A second study was awarded to CRF Health due to the success of this
study for patients and site staﬀ.
Using Reporting Dashboards for Real-Time Data Analysis
70,125 data points
The TrialMax platform did all the calculating for sites and study teams so that no errors were made when doing the math on the “total distance
walked” by subjects.
About CRF Health
CRF Health is the leading provider of patient-centered eSource technology and service solutions for the
life sciences industry. With experience in more than 800 trials, over 100 languages and across 74
countries, CRF Health’s TrialMax® platform consistently demonstrates the industry’s highest data
accuracy, patient and site compliance, and patient retention.
CRF Health’s eSource solutions improve trial engagement by fitting into the lives of patients and
seamlessly integrating into sites to maximize protocol compliance. The integrated TrialMax platform
includes eCOA solutions for collecting PROs (Patient Reported Outcomes), ObsROs (Observer Reported
Outcomes), ClinROs (Clinician or Rater Reported Outcomes), and PerfOs (Performance Outcomes), and
features TrialConsent™, an electronic solution for collecting informed consent in clinical trials.
For more information, please visit www.crfhealth.com
or email email@example.com