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Feasibility of a Home-based Self-Management Program for Chronic Fatigue

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41NR010496-01A1
Agency Tracking Number: NR010496
Amount: $99,885.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Solicitation Year: 2007
Award Year: 2007
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
WARREN, CT 06754
United States
DUNS: 782440049
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (860) 619-8069
Business Contact
Phone: (860) 619-8069
Research Institution

DESCRIPTION (provided by applicant): The long-term objective of this application is to establish a commercially viable program of illness self- management in people with unexplained chronic fatigue (UCF) and chronic fatigue syndrome (CFS). A successful self-management product has the potential (1) to improve the generally poor outcomes for UCF and CFS patients, (2) to greatly expand the availability of behavioral health care for UCF and CFS, and (3) to reduce medical and behavioral utilization for CF and CFS. Evaluation of self-management strategies that help people live with chronic illness and that maintain or improve quality of life is a major goal of NINR, a sponsor of the program announcement for this application. This Phase I application will evaluate the feasibility of a self-management program (2 CDs, self- management booklet and diary record forms) in a target sample of 38 persons with UCF or CFS. These Specific Aims will be assessed: (1) participant willingness to enter and complete the self-management program; (2) level of compliance with program assessments and weekly behavioral homework assignments; and (3) the ability of the program to individualize self-management prescriptions such that participant compliance and program effectiveness is maximized. Secondary exploratory aims are (a) to assess the effect sizes for the clinical outcomes of fatigue severity, physical and role functioning, and anxiety and depression; and (b) to assess fatigue coping styles among different cultural/ethnic groups. This self-management program represents a synthesis and extension of two previous face-to-face self- management trials in UCF (Chalder et al., 1997) and CFS (Powell et al., 2001). In this Phase I study, the feasibility assessment of a fully home-based self-management program will support a power analysis for a Phase II clinical efficacy trial of this UCF/CFS self-management product. A home-based commercially available illness management program for chronic fatigue is important because it potentially offers: (1) improved access to treatment for patients who may be unable or unwilling to travel to regular appointments; (2) a minimal time commitment and lower cost for higher credibility `self-management' in comparison to face-to-face counseling and longer-term mental health care; and (3) a substantially reduced illness burden and improved quality of life for people with unexplained chronic fatigue and chronic fatigue syndrome.

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

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