Web-based program for symptom management in fibromyalgia

描述（由申请人提供）：该二期项目将完成用于纤维肌痛（FM）症状管理和健康促进的SMART（自我监测和审查工具）日志程序的开发，并在一个大型基于网络的试验中评估其疗效，该试验将密切模仿其计划在三期的应用。SMART Log程序是一种基于网络的交互式自我监测和反馈干预，采用专有的统计分析程序，为个人用户提供行为、生活方式和应对策略方面的个性化优化指导，从而有效减少症状。该项目包括对个人自我监测数据的纵向收集和分析，然后从这些个人数据中获得个性化反馈。该项目帮助FM患者发现并监测特定的个人健康相关行为和管理策略与他们的症状水平之间的联系。在第一阶段，通过非常高的保留率、满意度评分和感知相关性、在使用期间使用对改善福祉的影响的证据以及表明对继续实施该计划的强烈兴趣的定性数据，证明了该干预措施的可行性。第二阶段的具体目标如下：目标1。根据第一阶段的研究结果，对SMARTLog程序仪器进行改进和优化。开发一个完全自动化的网站来管理SMARTLog程序。目标3。对修改后的自动化程序进行alpha测试。目标4。对至少2000名FM受试者进行为期9个月的大型试验（beta测试）。目标5。确定SMARTLog程序的可用性和满意度。目标6。确定SMARTLog程序的使用频率与FM症状、功能生活质量、健康自我效能、健康控制点和健康服务利用的变化之间的关系。目标7。评估使用模式，以确定使用的预测因素和中介因素。参与研究的受试者样本将根据他们在研究期间使用SMART Log程序的频率分为两组：“高利用率”和“低利用率”。假设：在使用期间，高使用率者在FM症状、功能生活质量、健康自我效能和健康控制点方面的改善显著大于低使用率者。第三阶段计划。商业化将采用三管齐下的盈利模式。(1)机构销售将包括健康倡导网站、健康保险公司和大型雇主作为疾病管理程序的许可使用。(2)订阅销售将通过患者个人订阅，通过提供SMART Log程序的公共门户访问。(3)广告销售将支持向订户提供节目的公共门户。我们的目标人群是所有使用互联网的FM患者，无论地理边界或个人移动能力的限制。该计划最初将以英语提供，其他语言可能会在第三阶段后期添加。创新。这将是第一个基于网络的自动化项目，将FM中的行为、自我管理策略和症状水平的纵向数据收集与基于个人数据的反馈相结合，以指导症状管理和健康促进。该产品将有可能扩展应用于其他健康状况，以及在III期。纤维肌痛是一种复杂的慢性疾病，影响着600 - 1200万美国人。自我管理策略在减轻症状和维持功能方面发挥关键作用。公共卫生相关性：拟议的项目提供了一个基于网络的自我管理工具，使FM患者能够识别他们个人症状水平与他们个人自我管理努力之间的重要联系，以便计划他们自己的最佳疾病管理方法。

DESCRIPTION (provided by applicant): 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.