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Efficacy of Home-Based Self-Management for Chronic Fatigue

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2011 / STTR
Agency Tracking Number:
R42NR010496
Solicitation Year:
2011
Solicitation Topic Code:
NINR
Solicitation Number:
PA10-051
Small Business Information
WARREN STRESS MANAGEMENT
15 Poughkeepsie Road West Cornwall, CT -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2011
Title: Efficacy of Home-Based Self-Management for Chronic Fatigue
Agency: HHS
Contract: 2R42NR010496-02
Award Amount: $666,888.00
 

Abstract:

DESCRIPTION (provided by applicant): The long-term objective of this proposal 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 these patients. Evaluation of self-management strategies that that improve quality of life is a major goal of NINR, a sponsor of the program announcement for this proposal. This Phase II study is a randomized trial of a feasibility-tested fatigue self-management program that compares three conditions: (a) the Phase I self-management product utilizing web diaries and actigraphs (FSM: ACT); (b) the Phase I self-management product utilizing inexpensive paper forms and step counters (FSM: CTR) as would be done in Phase IIIcommercialization; and (c) a wait list control condition. It is hypothesized that: (1) The FSM: ACT condition will be more efficacious than the wait list condition in lessening fatigue, improving functioning, and reducing depression. (2) The FSM: CTR condition will be more efficacious than the wait list control condition in lessening fatigue, improving functioning, and reducing depression. (3) Outcomes will not be significantly different between the FSM: ACT and FSM: CTR conditions. (4) The combined FSM conditions will be more cost effective than the wait list control condition. Our secondary aim will examine baseline behavioral outcome predictors including coping style, self-efficacy beliefs, and focusing on bodily symptoms. Phase III Commercialization. The self-management product will be promoted to (a) health plan decision makers (e.g., managed care companies and large employers),and (b) retail end users via targeted internet sites that offer products and support services to UCF/CFS patients. Commercial applications are potentially very broad given (1) the large population of individuals with UCF and CFS, (2) the high cost of (ineffective) medical care for these patients; (3) the unavailability of providers who administer behavioral treatment, and (4) theabsence of a generally accepted self-management program for this patient population. 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 substantiallyreduced illness burden and improved quality of life for these debilitated patients. PUBLIC HEALTH RELEVANCE: This proposal will test in a controlled clinical trial a home-based illness management program for people with chronic fatigue and chronic fatigue syndrome. The program involves learning lifestyle and stress reduction skills to reduce fatigue and improve quality of life. The product will be commercialized following this study. The self-management program 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 high credibility 'self-management' in comparison to face-to-face counseling; and (3) a substantially reduced illness burden and improved quality of life for these debilitated patients.

Principal Investigator:

Fred Friedberg
631-632-8252
fred.friedberg@stonybrook.edu

Business Contact:

Fred Friedberg
631-632-8252
fred.friedberg@stonybrook.edu
Small Business Information at Submission:

WARREN STRESS MANAGEMENT
15 Poughkeepsie Road West Cornwall, CT -

EIN/Tax ID: 112740635
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
Research Institution Information:
STONY BROOK UNIVERSITY
STONY BROOK UNIVERSITY
The Office of Sponsered Programs Melville Library Room 5501W
STONY BROOK, NY 11794-
Contact: