Web-Based Program for Symptom Management in Fibromyalgia

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43AR052640-01A1
Agency Tracking Number: AR052640
Amount: $100,000.00
Phase: Phase I
Program: SBIR
Awards Year: 2006
Solicitation Year: 2006
Solicitation Topic Code: N/A
Solicitation Number: PHS2006-2
Small Business Information
P.O. BOX 263, KITTERY POINT, ME, 03905
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (207) 450-0921
Business Contact
Phone: (207) 439-8049
Research Institution
DESCRIPTION (provided by applicant): Fibromyalgia (FM) is a complex chronic illness with no known medical cure. Its management depends heavily on the patient's daily efforts in lifestyle, behavior and self-care. Self-monitoring is key to effective self-management but is especially challenging in FM due to the impact of fatigue and cognitive symptoms. Based on a cognitive-behavioral approach, this Phase I project seeks to develop and test the feasibility of a practical, user-friendly tool to help FM sufferers discover linkages between their personal health management efforts and symptom levels over time. The tool will provide concrete feedback to each patient on her optimal profile of behavior and self-management strategies, derived from her own self- monitoring data. Aim 1: Develop a web-based self-monitoring regime that enables FM patients to longitudinally track their health-related behavior, health management strategies, and symptom levels over time. Aim 2: Develop a web-based statistical analysis algorithm that can process subjects' cumulative input data to generate feedback on relationships between their behaviors and symptom levels. Aim 3: Determine usability and satisfaction with the intervention. Aim 4: Evaluate the online data collection and analysis regimes to determine their sensitivity and ability to yield practical behavioral guidelines to patients. Aim 5: Collect preliminary data on longitudinal within-subject effects of use of the self-monitoring program on FM impact, functional quality of life, health self-efficacy and health locus of control. Hypothesis: We hypothesize that health self-efficacy and health locus of control will improve across the intervention period versus the control period. Method: We will conduct a study that includes a longitudinal, N-of-1 (single- subject), repeated measures design with a control phase and an intervention phase; a self-monitoring training workshop, a web-based self-monitoring and feedback program, a mid-study support meeting, and follow-up focus groups for qualitative feedback on the program. Outcomes will be assessed over four months using server-based and self-report measures. Feasibility will be evaluated in terms of both quantitative and qualitative data on usability and satisfaction. If feasibility is demonstrated we will propose a Phase II study to refine the self-monitoring regime, statistical analysis algorithm, and web site, followed by a large randomized controlled trial hosted by one of the world's largest FM support web sites to assess clinical outcomes.

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

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