This Phase II project will complete development of the SMART (Self-Monitoring and Review Tool) Log program for symptom management and health promotion in fibromyalgia (FM), and evaluate its efficacy in a large web-based trial that will closely emulate its planned application in Phase III. The SMART Log program is an interactive web-based self-monitoring and feedback intervention that employs proprietary statistical analysis procedures to give the individual user personally optimized guidance on behavioral, lifestyle and coping strategies that yield effective symptom reduction. The program incorporates longitudinal collection and analysis of the individual's self-monitoring data followed by delivery of personalized feedback derived from those same personal data. The program helps FM sufferers discover and monitor linkages between specific personal health-related behaviors and management strategies and their symptom levels over time. Feasibility of this intervention was demonstrated in Phase I by very high retention rates, ratings of satisfaction and perceived relevance, evidence of impact of utilization on improved well-being over the use period, and qualitative data indicating strong interest in continuation with the program.
Specific aims for Phase II are as follows:
Aim 1. Refine and optimize the SMARTLog program instruments based on the findings of Phase I.
Aim 2. Develop a fully automated web site for administering the SMARTLog program.
Aim 3. Conduct alpha testing of the revised and automated program.
Aim 4. Conduct a large trial (beta test) lasting nine months with a sample of at least 2000 FM subjects.
Aim 5. Determine usability and satisfaction with the SMARTLog program.
Aim 6. Determine the relationship between frequency of utilization of the SMARTLog program and change over the utilization period in FM symptoms, functional quality of life, health self-efficacy, health locus of control, and health service utilization.
Aim 7. Evaluate usage patterns to identify predictors and mediators of usage. The sample of subjects who participate in the study will be dichotomized into two comparison groups based on their frequency of utilization of the SMART Log program over the study period: """"""""high utilizers"""""""" and """"""""low utilizers."""""""" Hypothesis: High utilizers will show significantly greater improvements over the use period in FM symptoms, functional quality of life, health self-efficacy and health locus of control than low utilizers. Plan for Phase III. Commercialization will employ a three-pronged revenue model. (1) Institutional sales will consist of licensed use as a disease management program by health advocacy web sites, health insurance companies, and large employers. (2) Subscription sales will be via individual patient subscription for access over a public portal delivering the SMART Log program. (3) Advertising sales will support the public portal that delivers the program to subscribers. Our target population is the entire population of internet-using FM sufferers regardless of geographic boundaries or limitations on personal mobility. The program will be initially made available in English, and other languages may be added later in Phase III. Innovation. This will be the first automated, web-based program to integrate longitudinal data collection about behavior, self-management strategies and symptom levels in FM with personal data-based feedback to guide symptom management and health promotion. The product will be potentially expandable for application with other health conditions as well in Phase III. Fibromyalgia is a complex chronic illness affecting 6-12 million Americans. Self-management strategies play a key role in reducing symptoms and maintaining functioning. Public Health Relevance: The proposed project offers a web-based self- management tool that enables FM sufferers to identify significant linkages between their personal symptom levels and their personal self-management efforts over time in order to plan their own optimal approach to disease management.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44AR052640-03
Application #
7682195
Study Section
Special Emphasis Panel (ZRG1-RPHB-C (10))
Program Officer
Tonkins, William P
Project Start
2005-04-01
Project End
2011-08-31
Budget Start
2009-09-01
Budget End
2011-08-31
Support Year
3
Fiscal Year
2009
Total Cost
$297,224
Indirect Cost
Name
Collinge and Associates
Department
Type
DUNS #
143362023
City
Kittery
State
ME
Country
United States
Zip Code
03904