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eMedonline

To order this product, contact:

Barbara A. Rapchak, B.S.

Leap of Faith Technologies, Inc.

23 Brink Street, Crystal Lake, IL 60014

Phone: (815) 356-1767

Fax: (815) 356-1780

E-mail: brapchak@leapoffaith.com

Company Web Site: www.leapoffaith.com

Product Web Site: www.emedonline.com

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Product Description

Product Description

Cellphone Based Solution for Medication Compliance and Pharmacodiligence. Telehealth. Drug Telemonitoring.

Cost

Contact the Company for licensing and pricing information.

Product Type

Cellphone Based Solution for Medication Compliance and Pharmacodiligence. Telehealth. Drug Telemonitoring.

Who Is This Product For?

Patients, Payers, Clinical Research Organizations, Pharmaceutical Services Providers, Pharmaceutical Companies, Pharmacy Automation Companies

Where Is This Product Supposed to Be Used?

Outpatient settings, clinical trials, post market studies, Phase IV trials

Other Information

Awards

“World’s Best Technologies” 2005

Peer-Reviewed Publications

Not available at this time

Presentations

  • 2008 Medication Telemonitoring for Compliance and Pharmacodiligence
  • 2008 Medication Telemonitoring for Compliance, Pharmacodiligence, and e-Pedigree
  • 2008 Medication Management System for Clinical Trials

Press Releases

eMedonline To Be Showcased at Microsoft Health and Life Sciences
Solutions Conference

Medication telemonitoring technology is an enabling solution for compliance, pharmacodiligence, and e-pedigree

CHICAGO, April 2008-- Leap of Faith Technologies will showcase its medication telemonitoring technology for compliance, pharmacodiligence, and e-pedigree at the Microsoft Health and Life Sciences Solutions Conference in Atlantic City, N.J., April 22-24. eMedonline® integrates smartphones, radio frequency identification (RFID), and health and behavioral informatics to optimize medication compliance, track medication use, and extend patient care to the ambulatory setting. Built upon the Microsoft Windows Mobile platform, eMedonline is designed to be an enabling technology for mobility in healthcare.

“Patients who don’t comply with prescribed medications for chronic illnesses continues to be a serious issue plaguing the healthcare industry,” said Chris Sullivan, U.S. health provider solutions director, Microsoft Corp. “Leap of Faith Technologies’ eMedonline is a perfect example of how Microsoft and its partners can work together to solve this key industry problem and ultimately improve health around the world.”

The aging population, greater longevity, and medical advances mean that people are living longer with chronic illnesses. Medication is an efficient therapeutic strategy for treating chronic illnesses. However, the average rate of compliance with prescribed medications is only 50% after one year and continues to decline. Nearly 25% of all nursing home admissions and 25%-28% of all hospitalizations are due to noncompliance. Providing the additional service of medication compliance monitoring can save 20-40% of the total health care costs and as much as 90% of long-term care costs.

eMedonline, in effect, repurposes cellphones as medication sensors,” said Barbara Rapchak, CEO of Leap of Faith Technologies. “It goes beyond reminding patients to take their medications. It also allows them to easily monitor their own drug use, symptoms, treatment-associated side effects, and overall well-being.” Patients in trials funded by the National Cancer Institute report that the product makes them feel more confident that they will be able to manage their illnesses.

The technology enhances data quality and supports compliance, e-pedigree, and automation efforts, enabling secure, two-way data flow between the dispensation center and individual user. With increased regulatory scrutiny of new drug candidates by the FDA, the technology is especially relevant to Phase IV studies where it can automate data collection across large, widely distributed populations for extended periods of time.

Leap of Faith Technologies integrates existing and emerging technologies with behavioral informatics to improve patient compliance and healthcare outcomes. eMedonline was developed by Leap of Faith Technologies with support from the National Institutes of Health, National Cancer Institute, Contract #HHSN261200644005C.

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Utility of Drug Telemonitoring Validated by National Cancer Institute Testing

Technology “a great boon” for both patients and clinicians

CHICAGO, July 2008—New drug telemonitoring technology developed by Leap of Faith Technologies and supported by a contract from the National Cancer Institute (NCI) was recently validated in usability testing at NCI’s User-Centered Informatics Research Lab. The system, called eMedonline® (http://www.emedonline.com), is wireless solution for medication compliance and pharmacodiligence at the point of care. It integrates cellphones, radio frequency identification (RFID), and health and behavioral informatics to optimize medication compliance, track medication use, and extend patient care to the ambulatory setting.

Medication data read from an RFID tag on the medication package is collected wirelessly by the phone in real time and helps verify that patients are taking the right drug at the right time, while tracking adverse events. A web service makes the data readily available to clinicians. Alerts can be triggered, enabling intervention in the case of missed medications or adverse events before they become a significant health risk.

In the usability testing, clinical trial patients and clinical trial coordinators were recruited to use and evaluate the eMedonline system. Patients reported that the technology makes them feel more confident that they will be able to manage their medications. They said that the system was reassuring, kept them aware and in touch, and prevented them from disregarding important symptoms. Clinicians participating in the testing also gave the technology high marks. “What a great boon for the research nurse or clinical trial coordinator,” said one clinician.

Usability and workload were evaluated using the System Usability Scale (SUS) and Cooper-Harper Rating. The technology received optimum scores on both scales, indicating high usability and minimal workload. SUS scores range from 0-100, with 100 indicating optimal usability. eMedonline had a mean SUS score of 84.7. Cooper-Harper values range from 1-10, with 10 indicating minimal perceived mental workload. eMedonline had a mean score of 9.4.

With increased regulatory scrutiny of new drug candidates by the FDA, the technology is especially relevant to Phase IV studies where it can automate data collection across large, widely distributed populations for extended periods of time. The technology enhances data quality and supports automation efforts in clinical trials, enabling secure data flow from the dispensation center to the individual user.

eMedonline is designed to facilitate compliance data collection and help manage adverse events,” explains Barbara Rapchak, CEO of Leap of Faith Technologies. “The system goes beyond reminding patients to take their medications. It also helps them monitor their symptoms, side effects, and overall well-being using an off-the-shelf cellphone that integrates seamlessly into their lifestyle.”

Leap of Faith Technologies integrates existing and emerging technologies with behavioral informatics to improve patient compliance and healthcare outcomes. eMedonline was developed by Leap of Faith Technologies with support from the National Institutes of Health, National Cancer Institute, Contract #HHSN261200644005C.

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National Cancer Institute Funds Telemonitoring for Medication Compliance

Technology should improve compliance and facilitate post-market drug studies

CHICAGO, January 2008-- Increased use of oral cancer drugs has raised concerns about patient compliance. A review in the Journal of the National Cancer Institute (NCI) found that up to 80% of cancer patients failed to follow their prescriptions. The risk to patients is substantial. Patients who take too much chemotherapy risk a toxic reaction or long-term damage. Patients who take too little lose the drug’s therapeutic benefits.

NCI has awarded Leap of Faith Technologies an $883,593 contract to further develop its drug telemonitoring technology, called eMedonline® (http://www.emedonline.com), for use in oncology and clinical trials.

eMedonline integrates cellphones, radio frequency identification (RFID), and health and behavioral informatics to optimize compliance, track medication use, and extend patient care to the ambulatory setting.

eMedonline is designed to facilitate compliance data collection and help manage adverse events,” explains Barbara Rapchak, CEO of Leap of Faith Technologies. “The system goes beyond reminding patients to take their medications. It also helps them monitor their symptoms, side effects, and overall well-being using an off-the-shelf cellphone that integrates seamlessly into their lifestyle.”

eMedonline can be thought of as a “smart service” that leverages the inherent abilities of wireless technologies like cellphones and RFID. Medication data read from an RFID tag on the medication package is collected wirelessly in real time and helps verify that patients are taking the right drug at the right time, while tracking adverse events. A web service makes the data readily available to clinicians. Alerts can be triggered, enabling intervention in the case of missed medications or adverse events before they become a significant health risk.

According to the New England Journal of Medicine, clinical trials report average adherence rates of only 43%-78%. It costs an average of $6533 to recruit a patient for a trial, and three times that amount to recruit a new patient if one is lost due to noncompliance.

eMedonline cost-effectively and accurately tracks drug distribution, dosing times, and missed doses, eliminating costly uncertainty about efficacy and the need for manual data entry. This can reduce the cost and time to bring a drug to market.

With increased regulatory scrutiny of new drugs by the FDA, the technology is especially relevant to Phase IV studies where it can automate data collection across large, widely distributed populations for extended periods of time.

Leap of Faith Technologies integrates existing and emerging technologies with behavioral informatics to improve patient compliance and healthcare outcomes. eMedonline was developed by Leap of Faith Technologies with support from the National Institutes of Health, National Cancer Institute, Contract #HHSN261200644005C.

Organizations/Consortium Worked with During Project

Radiation Therapy Oncology Group (RTOG) at the National Cancer Institute

BARBARA: CHECK THIS

Commercial Collaborations/Actual Purchasers

Palm Corporation

Hewlett-Packard

Microsoft Corporation

Biologics

Patent, License, Trademark

Patent No.7,002,476

eMedonline is a Trademark of Leap of Faith Technologies, Inc.

Societal or Research Contribution/Success Story

We have demonstrated that smartphones incorporating RFID can be used as medication sensors to help patients identify the right drug at the right time, facilitate compliance with complex medication regimens, report adverse events, and monitor health status. Patients in early studies report greater self efficacy in managing their medications when using the technology.

Research Description

Grant Title

eMedonline Medication Management System for Clinical Trials

Grant Number

HHSN261200644005C

Abbreviated Abstract

The National Cancer Institute and the Clinical Center at NIH recognize the need for technologies that support clinical trials. A study of the “state of the science” revealed that cancer centers need systems that automate data collection for the benefit of clinical and research staff. Poor patient compliance with drug regimens in clinical trials can make it difficult to detect the therapeutic effect of drugs that have potential benefit to patients, and can affect the ability to make a rational clinical decision about further therapy. Systems that cost-effectively and accurately track dosing times and missed doses, and that eliminate costly uncertainty and the need for data entry from patient diaries are needed. This contract resulted in the development of a medication management system that integrates health and behavioral informatics, cellphone technology, and radiofrequency identification (RFID) to improve compliance among patients participating in clinical trials. Phase I feasibility and functional tests of such a system in a sample of drug clinical trial patients demonstrated that compliance-related data can be accurately collected, analyzed, and exported for use in other clinical monitoring systems. Furthermore, patient acceptance and value of such a system is high. Phase II assesses the overall acceptability and feasibility of the approach in a larger sample of clinical trial patients. Compliance and patient satisfaction will be evaluated.

Primary Investigator

Barbara A. Rapchak, B.S.

About PI

Barbara Rapchak is the Founder and CEO of Leap of Faith Technologies. She is the inventor of a patented telehealth device that was selected as one of the “World’s Best Technologies”, and a pediatric oncology product that received the “World Wide Web Health Award”. She accepted the U.S. SBA Tibbetts Award for Leap of Faith Technologies for its innovations in e-health. She has led various research and development teams, and is a committed technology partner and collaborator. She has been the Principal Investigator on twelve Small Business Innovation Research Grants and Contracts. Her work in behavioral informatics and information design is influenced by research in the areas of cognitive science and the field of usability engineering, which characterizes the interaction of users with information technologies. Prior to founding Leap of Faith Technologies, she held research positions for Amoco and American Can Company, and an executive position at Bio-Imaging Research. She has a degree in Lifesciences from the University of Notre Dame.

Research Team & Affiliations

Leap of Faith Technologies, Inc. :

Barbara Rapchak, PI and James Hopkinson, Ph.D., Senior Computer Scientist

Consultants

Robert Wehbie, M.D., Oncology & Infectious Diseases, Cancer Centers of North Carolina & the U. of North Carolina

Robert Grammling M. D., University of Rochester School of Medicine and Dentistry

Research Objectives

Aim 1:

Develop a pre-production prototype of the eMedonline system to enhance medication compliance for patients and facilitate data collection and record keeping for research staff

Aim 2:

Assess the acceptability of the system among patients and research staff.

Aim 3:

Evaluate effects on medication compliance and self-efficacy.

Theory/Hypotheses

We hypothesize that subjects in the test group who use eMedonline will report better self efficacy relative to managing their medications as compared to subjects in the control group.

We hypothesize that the eMedonline system will have a positive effect on medication compliance for subjects in the test group as compared to subjects in the control group.

Experimental Design

Leap of Faith Technologies is conducting the Phase II study jointly with the Radiation Therapy Oncology Group (RTOG) in a controlled pilot at multiple sites. This is a randomized, controlled study with a crossover design. Patients are randomized to one of two groups: use pill counts (control condition) for 1 month, followed by 1 month of the eMedonline system plus pill counts (test condition), or vice versa. Order is randomly assigned.

Final Sample Size & Study Demographics

Subjects are randomized to, and expected to complete treatment on, one of the concurrent temozolomide/radiotherapy arms of RTOG 0834 (i.e., Group 2 or Group 4). N = 26

Data Collection Methods

Data collection is by means of survey instruments, and by the telehealth device (smartphone). The following data is collected via the telehealth device:

• Medication Time — date and time when the patient scans the medication in preparation

for taking it

• Compliance Time — the difference between the patient’s scheduled time and that the

actual time that he/she scanned the medication

• e-Diary — report of compliance, general well-being, coping, and specific side effects.

Outcome Measures

Primary endpoints

To determine whether the eMedonline medication management system has a positive effect on medication compliance as measured by data collected from pill counts.

To compare measures of medication compliance using the telehealth device and eMedonline system vs pill counts.

To evaluate changes in measures of self-efficacy in one’s capacity to comply with the medication regimen and health-related functioning.

Secondary endpoints

To assess the overall acceptability of eMedonline among patients as measured by the User Experience Survey.

Evaluation Methods

Compliance

Given the randomized design for this study, we will assume that base rates of compliance will be similar across study groups (~68%) as defined by the proportion of the group taking 100% of the prescribed doses.4 Our main study outcome will be the compliance at follow-up as measured by pill counts in both groups. Our main objective for this measure is to estimate the potential effect size. We will follow an intention-to-treat paradigm for all analyses.

Given 13 subjects per randomized arm of this study, we would need to observe an average of 96.5% of doses taken in the intervention group to obtain 80% power with an alpha of 0.05. This is based upon the following assumptions: mean of 85% of doses taken in the control arm, standard deviation of 10 in both groups, normal distribution of the doses taken. This is based upon a 2 sample, 2-sided t-test for equality of means.

Self-efficacy

Self-efficacy, or confidence, is a major predictor of habitual health behavior. We are assessing self-efficacy via 2 items (convenience and capacity to comply with medication regimens). Each item is reported on a 5-point ordinal scale (0-4). Global self-efficacy will be the additive sum of responses, with a potential range of 0 to 8. We consider a 2-point improvement in global self-efficacy to represent a clinically relevant difference. We will evaluate the proportion of participants reporting an improvement in self-efficacy within each study group. Difference in proportion will be determined by standard chi-square analyses.

Research Results

Phase I

   Patients responded positively to their experience with the system, finding it to be easy to use, helpful in understanding what medications they were taking and why they were taking them, and would recommend eMedonline to others.

   The medication compliance rate was 96% as calculated using data collected from the eMedonline device.

   The compliance rate was corroborated by self-report data from e-Diary entries.

   Compliance was timely. 91% of the patients confirmed that they had the medication in hand within five minutes of the scheduled time.

   e-Diary compliance was 100% and timely. Diary entries were made within two minutes of the e-Diary prompt 96% of the time.

Phase II

eMedonline was validated in usability testing at NCI’s User-Centered Informatics Research Lab. Clinical trial patients and clinical trial coordinators were recruited to use and evaluate the eMedonline system. Patients reported that the technology makes them feel more confident that they will be able to manage their medications. They said that the system was reassuring, kept them aware and in touch, and prevented them from disregarding important symptoms. Clinicians participating in the testing also gave the technology high marks. It was credited with being “a great boon for the research nurse or clinical trial coordinator.”

Usability and workload were evaluated using the System Usability Scale (SUS) and Cooper-Harper Ratin. The technology received optimum scores on both scales, indicating high usability and minimal workload. SUS scores range from 0-100, with 100 indicating optimal usability. eMedonline had a mean SUS score of 84.7. Cooper-Harper values range from 1-10, with 10 indicating minimal perceived mental workload. eMedonline had a mean score of 9.4.

The RTOG trial is ongoing.

Barriers & Solutions

A key criteria in the software design and system architecture was that it had to be able to accommodate ever-evolving cellphone and RFID hardware, as well as other platforms. By implementing a very careful, thorough, iterative design and review process, by engaging end users and stakeholders early on, and by inventing new paradigms to describe the way people live with technology relative to prescribed therapies, we were able to achieve this.

Total Budget

$983,593

Products Developed from This Research