Web-Based Program for Symptom Management in Fibromyalgia

描述（由申请人提供）：纤维肌痛（FM）是一种复杂的慢性疾病，没有已知的药物治疗。其管理在很大程度上取决于患者在生活方式，行为和自我护理方面的日常努力。自我监控是有效自我管理的关键，但由于疲劳和认知症状的影响，FM尤其具有挑战性。基于认知行为的方法，这个第一阶段项目旨在开发和测试一个实用的，用户友好的工具，以帮助FM患者发现他们的个人健康管理工作和症状水平之间的联系随着时间的推移的可行性。该工具将向每位患者提供关于其最佳行为概况和自我管理策略的具体反馈，这些反馈来自患者自己的自我监测数据。目标1：开发一个基于网络的自我监测机制，使FM患者能够纵向跟踪他们的健康相关行为，健康管理策略和症状水平。目标二：开发一种基于网络的统计分析算法，可以处理受试者的累积输入数据，以生成关于其行为和症状水平之间关系的反馈。目标3：确定干预的可用性和满意度。目标4：评估在线数据收集和分析制度，以确定其敏感性和能力，为患者提供实用的行为指南。目标5：收集关于使用自我监控程序对FM影响、功能性生活质量、健康自我效能和健康控制点的纵向受试者内效应的初步数据。假设：我们假设，健康自我效能和健康控制点将改善整个干预期间与控制期。方法：我们将进行一项研究，包括一项纵向、N-of-1（单一受试者）、重复测量设计（包括控制阶段和干预阶段）;一个自我监测培训研讨会、一个基于网络的自我监测和反馈计划、一个研究中期支持会议和后续焦点小组，以获得对该计划的定性反馈。结果将在四个月内使用基于服务器和自我报告的措施进行评估。可行性将根据可用性和满意度的定量和定性数据进行评估。如果可行性得到证实，我们将提出一项II期研究，以完善自我监测机制、统计分析算法和网站，然后由世界上最大的FM支持网站之一主办一项大型随机对照试验，以评估临床结果。

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.