Smartphone Delivered Comprehensive Heart Failure Self-management System

Award Information
Department of Health and Human Services
Award Year:
Phase I
Agency Tracking Number:
Solicitation Year:
Solicitation Topic Code:
Solicitation Number:
Small Business Information
441 Wolf Ledges, AKRON, OH, 44311-
Hubzone Owned:
Minority Owned:
Woman Owned:
Principal Investigator:
(330) 258-9000
Business Contact:
(330) 258-9000
Research Institution:

DESCRIPTION (provided by applicant): Creative Action LLC plans to market a comprehensive heart failure self-management system. The system enables data gathering and monitoring using of a smartphone with web-based management software. University research centers will be the initial market for our product. Called the iRxReminder System, this comprehensive self-management system is specifically designed to support use by older adults. The system brings together state-of-the-art medication reminding, customizable surveying, education, and real-time field data reporting modules in a completely portable package. Successfully tested for feasibility and use with post-stroke patients in a pilot study, the iRxReminder System will be integrated with existing electronic medical record (EMR) systems of collaborating partners in Phase II Our hardware includes a desirable smartphone and integrated pill carrier that encourages an individual to 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 is pending. Pilot results successfully demonstrate older adults have an interest in and capacity to sufficiently use the smartphone features available for medication adherence, completing interactive surveys, learning from the multimedia educational materials presented, and providing data such as weekly weight to researchers. Phase I results are intended to determine recruitment rates, participationrates, and workable field test data collection procedures for a fully powered health outcomes study in Phase II. Heart failure contributes to low cognitive capacity due to the pathophysiology of heart failure (e.g. reduced cerebral blood flow), as well asfatigue and stress. Worsening cognitive function as a result of heart failure explain in part why interventions to enhance self-management in this population have had limited success. The purpose of this proposal is to develop and test a comprehensive self-management system that would be appropriate for use in a larger randomized controlled trial. Social Cognitive theory indicates that a smartphone-based chronic disease self-management system will improve adherence and will provide appropriate cognitive supports to overcome the effects of cognitive impairment on medication adherence, daily weighing, and sodium restriction. Phase I is intended to demonstrate if heart failure patients will accept and use the comprehensive system in the short-term (28-days), and later in a 12-month study in Phase II. PUBLIC HEALTH RELEVANCE: Chronic illnesses costs 1.95 trillion annually. Chronic conditions affect nearly half of all Americans and consume 85% of all health care spending. Secondary prevention of the complications associated with chronic conditions is essential in order to maximize health and quality of life. The chronic care literature indicates that for many chronic illnesses, an interdisciplinary evidence-based care management approach is the most effective way to prevent secondary complications. The public health burden of heart failure (HF) is staggering, as over 5 million Americans are affected and the annual costs exceed 43 billion. Much of the costs associated with HF are attributable to re-hospitalization that is a result from the failure of the patient to manage the complex treatment regimen. Successful self-management results from adherence to the treatment regimen and effective decision making with action regarding corrective action when HF symptoms are exacerbated. Meta- analyses of interventions to improve medication adherence reveal disappointing effectiveness of these efforts, underscoring the need for better interventions to improve patient self-management. As an alternative to comprehensive care management, there is a growing body of research indicating technology supported self-management that includes education, adherence support (e.g. reminding) and monitoring may be as effective, more accessible, and more cost effective for everyone in general, and older adults in particular.

* information listed above is at the time of submission.

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