CF-ePRO: Electronic Self- and Parent-Reported Patient Outcomes in Cystic Fibrosis

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R41HL098985-01A1
Agency Tracking Number: R41HL098985
Amount: $306,380.00
Phase: Phase I
Program: STTR
Awards Year: 2011
Solicitation Year: 2011
Solicitation Topic Code: NHLBI
Solicitation Number: PA10-051
Small Business Information
1121 34th Ave., SEATTLE, WA, 98122-5138
DUNS: 101064988
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (206) 748-0443
Business Contact
Phone: (206) 748-0443
Research Institution
Office of Sponsored Programs 4333 Brooklyn Ave NE Box 359472
SEATTLE, WA, 98195-9472
 () -
 Nonprofit college or university
DESCRIPTION (provided by applicant): The first goal of Healthy People 2010 is to help individuals of all ages increase life expectancy and improve their quality of life. Individuals with cystic fibrosis (CF), a life-shortening chronic disease affecting ~30,000 individuals in the U.S., suffer from chronic respiratory symptoms. Periods of acute symptom worsening, known as pulmonary exacerbations, have a major impact on survival, quality of life, and cost of care among CF patients. Currently, pulmonary exacerbations are identified only when an individual seeks care. Data from CF and chronic obstructive pulmonary disease suggest that earlier identification and intervention lead to more rapid recovery, reduced cost of care, and improved outcomes. Routine patient-recorded observations of respiratory health could facilitate this. The objectives of this small business technology transfer (STTR) application are 1) to develop a personalized electronic disease self- management tool, CF-ePRO, for patient-recorded observations of respiratory health using existing CF respiratory symptom diaries for patients aged 7-11 years and 12 years to adulthood, and 2) to create a parent-reported sign instrument for CF patients 0 to 6 years of age, enabling age-appropriate versions of the CF-ePRO for all CF patients. CF-ePRO will be designed to be customizable for use in clinical care and to serve as a clinical trial endpoint. The specific aims of this Phase I project are to 1) produce a prototype of CF-ePRO to work with any smartphone or desktop PC with web access, 2) conduct formative lab- and field-based usability testing with CF patients, 3) conduct formative focus groups with key CF clinical care stakeholders, 4) create a parent-report respiratory sign instrument for CF patients 0-6years old as none currently exists for this age group, and 5) evaluate proof-of-concept and Phase II readiness according to quantifiable benchmarks. In Phase II, we propose to enhance the CF-ePRO by adding routine home spirometry and objective monitoring of cough frequency and intensity and to conduct a randomized controlled trial of CF-ePRO monitoring compared to conventional care. In keeping with the intention of the STTR program to stimulate a partnership of ideas and technologies between innovative small businesses and non-profit research institutions to create commercializable innovative technologies, we have assembled a multidisciplinary team of investigators from Talaria, Inc., Seattle Children's Hospital, and the University of Washington. We anticipate that CF-ePRO will be highly marketable, of great interest to CF patients and care centers as well as to academic and pharmaceutical researchers planning therapeutic trials. PUBLIC HEALTH RELEVANCE: Cystic fibrosis (CF) is a chronic lung disease that affects about 30,000 people in the U.S., causing suffering and premature death. A system to help CF patients to track their symptoms, using computers or cell phones, could help them know when to seek care sooner and, in turn, live longer with a betterquality of life. We propose to build and test such a system.

* Information listed above is at the time of submission. *

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