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PHT LogPad Enables Temple University to Examine Clinical Benefit of a Medical Call Center Upon Patients With COPD; Novel Trial Aims to Reduce COPD-Related Deaths and Hospitalizations, Improve Quality of Life, Lung Function and Everyday Activity

Posted on: Monday, 17 July 2006, 15:00 CDT

PHT Corporation, the market-leading provider of electronic patient reported outcome (ePRO) solutions used in a record 225 dedicated eDiary trials worldwide, is pleased to announce another first for its LogPad(R) System. Temple University School of Medicine has selected the LogPad for use in a novel study investigating the potential clinical benefit of using call centers, staffed by pulmonary medical personnel, to support and follow up with Pennsylvania residents suffering from chronic obstructive pulmonary disease (COPD). This trial is unique because it is not evaluating a study drug, but rather the impact patient access to a call center may have on reducing hospitalizations and deaths due to COPD exacerbations and on improving patient quality of life, lung function, and everyday activity levels.

In the study, 400 subjects enrolled at four PA sites, coordinated by Temple, will be assigned individual LogPads on which they will record and transmit symptom and quality of life data on a daily basis. The LogPad, implemented by PHT on Palm, Inc. handheld devices, automatically calculates a graded score from baseline and triggers an on-screen alert telling the patient to contact the call center if certain thresholds are reached. At the same time, PHT StudyWorks(TM) allows call center personnel to review real-time reports online, enabling them to prepare for a subject's call or to identify and contact patients who triggered an alert but chose not to call.

"COPD patients frequently have prodromal symptoms that herald an impending exacerbation which are rarely reported to their physicians," said Gerard J. Criner, M.D., Professor of Medicine at Temple University School of Medicine and Director of the Temple Lung Center at Temple University Hospital. "The capability for caregivers to identify early warning signs of an exacerbation in real time is lacking. Improving the classification and quantification of symptoms that herald an exacerbation may greatly benefit those who suffer from COPD."

According to the Pennsylvania Department of Health, which awarded over $4.7 million to implement PA-SCOPE, COPD was responsible for 8 million office visits, 1.5 million emergency room visits, 726,000 hospitalizations, and 119,000 deaths in the year 2000 throughout the United States. The disease is especially problematic in Pennsylvania, where chronic respiratory lung diseases are the 4th leading cause of death and the age-adjusted mortality rate for COPD is 80% higher than the national average. In fact, Pennsylvania spends at least $400 million per year treating acute episodes of COPD. As the population ages, these costs will still soar even if smoking cessation programs are successful.(1)

It is difficult to imagine the feasibility of implementing this study on paper. The graded scoring on the LogPad removes the burden from subjects to perform manual daily calculations of their score for two years. With a paper diary, subjects could potentially make calculation mistakes or forget to complete them every day. In addition, real-time access to subject diary compliance, symptom and triggered alert data empowers site staff with information on symptom scores and alerts every day, rather than only during study visits.

"The main benefit of PHT's solution is the ability to review the patient symptom data in real time," said Carla Grabianowski, RN, BSN, CCRP, Research Nurse Coordinator (Pulmonary & Critical Care Medicine) at Temple University Hospital. "In this study, patients go six months between study visits. If we had used paper diaries for the study, we may not have had any information during this time. It would have been harder to track compliance and whether patients were scoring correctly. Most importantly, it would have been difficult to know whether a patient in the group with access to the call center number was exhibiting early signs of an exacerbation and in need of call center intervention if those patients simply chose not to call when they should have."

While results of the study are preliminary, PA-SCOPE is a novel use case of electronic patient diaries, which are normally employed to collect ePRO data evaluating the effects of a study drug. This example further illustrates the ever-increasing abilities of PHT's LogPad System to assist clinicians in answering important and persistent health status questions.

For more details on the innovative study, review the full case study located online at: http://www.phtcorp.com/Experience/case_studies.asp.

About the Temple University School of Medicine

Since the Temple University School of Medicine (TUSM) opened its doors in 1901, it has been a pioneer in academic medicine and research, while also serving the community - a proud legacy for today and generations to come. The School is guided by its mission each day: to educate superior physicians, enhance research and knowledge, and improve health care in the North Philadelphia community, as well as the greater Philadelphia region.

Medical research at Temple flourishes in both the clinical and basic science realms. Research strengths lie in pulmonary, cardiology and gastroenterology, and interdisciplinary research centers include the Cardiovascular Research Group; the Center for Substance Abuse Research; the Sol Sherry Thrombosis Research Center; the Fels Institute for Cancer Research and Molecular Biology; the Center for Minority Health Studies, the Center for Neurovirology and the Center for Obesity Research and Education. For more information, visit: www.medschool.temple.edu.

About PHT Corporation

PHT is the market-leading provider of electronic patient reported outcome (ePRO) solutions used in over 225 clinical trials worldwide. Subjects of all ages use PHT's LogPad(R) and StudyPad(R) systems, in over 70 languages and 60 countries around the world, to enter and transmit nearly 10,000 electronic reports every day. This high quality and timestamped data is used by over 70 unique biopharmaceutical and medical device companies to measure the safety and efficacy of new treatments for dozens of therapeutic areas and indications including pain, asthma, allergy, GI and CNS. The data is available for real-time online review by sites and sponsors through PHT StudyWorks(TM), enabling responsive subject compliance and enrollment management.

PHT, the industry leader in both experience and innovation, was the first ePRO provider to implement a study in Japan, to incorporate Indic languages on an eDiary, and to wirelessly integrate measurement devices with eDiaries for an upcoming trial. Subject experiences, captured firsthand by PHT's user-friendly ePRO systems, have been successfully used in at least six NDA submissions, with three known approvals to date. To find out why leading biopharmaceutical companies worldwide rely on PHT's ePRO solutions to improve data quality, reduce data variance and enhance trial management efficiencies, visit www.phtcorp.com.

LogPad, StudyPad and PHT are registered trademarks of PHT Corporation. StudyWorks is a trademark of PHT Corporation.

(C) 2006 PHT Corporation

(1)"Health Research Non-Formula Grants." Pennsylvania Department of Health. URL: http://www.dsf.health.state.pa.us/health/lib/health/cure/ 2003_Nonformula_Grants_SFY_03-04_.pdf (Due to the length of this URL, it may be necessary to copy and paste it into your Internet browser's URL address field. You may also need to remove an extra space in the URL if one exists.)

Source: Business Wire

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