Creative Action LLC, based in Akron, Ohio, plans to bring to market a personal digital assistant-based health data gathering and reporting system. Researchers interested in studying the effects of medications on older adults will be the initial market for our product. We call our medication adherence and data gathering system the iRxReminder"""""""" System. The software is specifically designed and will be tested for use by older adults. The software is specifically designed and will be tested for use by older adults. The system brings together state-of- the-art medication reminding and real-time field data collection and reporting software in a completely portable package. With our commercial partners we will integrate the iRxReminder System with existing electronic medical record systems in Phase II. Our hardware includes a desirable personal digital assistant and integrated pill carrier that ensures an individual will carry the system with them. The pillbox case has been awarded a utility patent (US Patent No. 7337899), nine design patents (US Patent No. D501303-D501309, D509055 Pillbox), and one patent pending. Phase I will include development of the software and completion of a feasibility study. Eligible ischemic stroke and transient ischemic attack (TIA) patients undergoing acute treatment at a regional hospital will be approached for consent and then randomized into either the intervention or control group. At the time of randomization, patients in the control group will receive a post-stroke education and medical information diary to assist them in post-discharge self-management. Patients in the intervention group will receive a personal digital assistant with the iRxReminder software preprogrammed with their medication regimen, and a case with the integrated pillbox. Patients will receive training in use of the all the features of the personal digital assistant at a home visit, including practice responding to the iRxReminder medication-taking and survey prompts. The objectives of Phase I are to demonstrate that older adults have an interest in and capacity post-stoke to sufficiently use the features available and to demonstrate successful usage following training, both through a comprehensive mastery test and through 60 days of usage. At the end of 60 days statistical test will be used to determine if older adults utilize the device in improving self-management of care following a stroke through steady use of software that supports 1) medication reminding, 2) medical and attitudinal surveying, and 3) presentation of educational materials related to stroke;compared to a control group using a printed booklet used in a previous post-stroke care study. The feasibility study will provide the field experience necessary to determine recruitment rates, participation rates, and workable field test data collection procedures for a fully powered health outcomes study in Phase II.

Public Health Relevance

Medication-related problems represent a huge cost to the United States economy. Estimates range from $76 billion dollars (Johnson &Bootman, 1995) to $177 billion (Ernst and Grizzle, 2001). Lack of adherence leads to unnecessary disease progression, disease complications, reduced functional abilities, lower quality of life, and even premature death. Our previous lab (Sterns and Mayhorn, 2006) and extended field research (Sterns, 2005) with 44 older adults (M = 72 yrs.) using a Smartphone in combination with an attached pillbox case provided evidence of 1) improving medication adherence;2) serving as a link between specialists medicating the individual;and 3) providing feedback to healthcare professionals to better direct medication regimens. The proposed research will demonstrate the feasibility of the system for older adults in Phase I, and demonstrate the utility of the information provided for physicians and for older adult patients in Phase II. Over time, we believe the product can evolve to serve as a cognitive prosthesis for older adults that will reduce overall treatment costs and extend independence and enhance successful aging.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43AG033500-01
Application #
7611869
Study Section
Special Emphasis Panel (ZRG1-RPHB-C (10))
Program Officer
Joseph, Lyndon
Project Start
2009-02-01
Project End
2010-04-30
Budget Start
2009-02-01
Budget End
2010-04-30
Support Year
1
Fiscal Year
2009
Total Cost
$257,758
Indirect Cost
Name
Creative Action, LLC
Department
Type
DUNS #
859406332
City
Akron
State
OH
Country
United States
Zip Code
44311