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Case Study
TrialMax Slate®
Reduces Site Burden
Conducting 6-Minute
Walk Test
Case Study
The 6MWT required many elements outside of a simple question and answer format, which made using paper less tha...
Case Study
Study Design
Study Solution
380Screened Subjects
236Randomized Subjects
88Sites
15Countries
20Languages
Because...
Case Study
Following receipt of the TrialMax Slate tablet devices, sites were tasked
with setting up subjects and activati...
Case Study
Paper made it very difficult for study teams to analyze and report subject performance data, especially in real-...
About CRF Health
CRF Health is the leading provider of patient-centered eSource technology and service solutions for the
l...
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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.

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Case Study: TrialMax Slate® Reduces Site Burden Conducting 6-Minute Walk Test

  1. 1. Case Study TrialMax Slate® Reduces Site Burden Conducting 6-Minute Walk Test
  2. 2. Case Study 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. Study Overview 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 indications: Chronic Obstructive Pulmonary Disease (COPD) Cystic Fibrosis Peripheral Vascular Disease Pulmonary Hypertension … 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 imperative. 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 data comparison.
  3. 3. Case Study Study Design Study Solution 380Screened Subjects 236Randomized Subjects 88Sites 15Countries 20Languages 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
  4. 4. Case Study 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. Pictured above: 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. Pictured below: 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
  5. 5. Case Study Paper made it very difficult for study teams to analyze and report subject performance data, especially in real-time. TrialManager was the answer to that problem. 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 study. 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. Implementing TrialManagerTM Using Reporting Dashboards for Real-Time Data Analysis Study Results 70,125 data points collected Pictured above: 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.
  6. 6. 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 info@crfhealth.com

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