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临床试验/NCT02515552
NCT02515552已完成2 期

Web-Based Program for Symptom Management in Fibromyalgia

Collinge and Associates, Inc.2 个研究点 分布在 1 个国家目标入组 883 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
883
试验地点
2
主要终点
Change in daily symptom Levels

研究概览

简要总结

Fibromyalgia is a complex chronic illness affecting 6-12 million Americans. Self-management strategies play a key role in reducing symptoms and maintaining functioning. 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.

详细描述

This Phase II project will complete development of the SMART (Self-Monitoring and Review Tool) Log program for symptom management and health promotion in FM and evaluate its efficacy in a large web-based trial that will closely emulate its planned application in Phase III. The SMARTLog program is an interactive web-based self-monitoring and feedback intervention that employs proprietary statistical analysis procedures to give the user personally optimized guidance on behavioral, lifestyle and coping strategies that yield effective symptom reduction for that individual. 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 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-reported presence of fibromyalgia

排除标准

  • 未提供

结局指标

主要结局

Change in daily symptom Levels

时间窗: Baseline to user-defined end date (variable time series design) up to 9 months

Change in Likert-scaled (0-10) daily symptom severity levels on the SMARTLog tracking instrument. Daily reported levels over multiple days are aggregated to calculate trends over the user-defined reporting period.

次要结局

  • Change in Self-Efficacy for Chronic Disease Scale scores(Baseline to user-defined end date (variable time series design) up to 9 months)
  • Change in Fibromyalgia Impact Questionnaire scores(Baseline to user-defined end date (variable time series design) up to 9 months)
  • Change in SF12 scores(Baseline to user-defined end date (variable time series design) up to 9 months)
  • Change in Multi-dimensional Health Locus of Control Scale scores(Baseline to user-defined end date (variable time series design) up to 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Collinge, PhD

President

Collinge and Associates, Inc.

研究点 (2)

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