Optimizing Fibromyalgia Self-Management

优化纤维肌痛自我管理

基本信息

批准号：
7115752
负责人：
DANIEL S ROOKS
金额：
$ 10.94万
依托单位：
BETH ISRAEL DEACONESS MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2002
资助国家：
美国
起止时间：
2002-06-01 至 2007-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7115752
关键词：
adult human (21+)behavioral /social science research tag clinical research clinical trials coping exercise female fibromyalgia functional ability health care cost /financing health care service utilization health education human subject human therapy evaluation musculoskeletal disorder therapy patient oriented research self care self concept

项目摘要

DESCRIPTION (provided by applicant): Fibromyalgia syndrome (FMS) is a common, chronic musculoskeletal disorder and a growing cause of disability and increased health care utilization. Current treatment focuses largely on pharmacological intervention, which is often ineffective at improving symptoms and functional status. Recent research suggests that disease self-management can be efficacious in the short-term at reducing symptom severity and improving function in persons with FMS. The most common forms of FMS self-management are coping skills, training (behavioral/education) and exercise. Limited in number, most FMS self-management studies examine the short-term effects of one form or the other, with most using the coping skills training approach. Little data exist to examine the long-term effects of these interventions, the potential additive effect of combining coping skills training with a comprehensive, group exercise program or an approach for promoting long-term compliance of these interventions. The objective of this proposal is for the PI to acquire new competencies in the area of health behavior; to expand research skills; and to apply this knowledge in a study to identify the optimal approach to FIVIS self-management. The PI will combine formal learning in health and social behavior, research design and analysis, and ethics in clinical research with informal learning, in a proven academic training environment under the guidance of a committed mentor. The study is a randomized, controlled trial comparing coping skills training (the Arthritis Foundation Fibromyalgia Self-Help Course (FSHC)) with a comprehensive exercise program (previous work of PI), a combination (the FSHC plus the exercise program) or no treatment (waiting list control). Each intervention period will last 16 weeks and include group sessions led by trained personnel. Subjects will be followed for 6 months after completing the intervention to evaluate the short-term effect of each program. At 6 months, subjects will be randomized into two groups-one group will receive a 4 week refresher course of their original intervention every 6 months and the other group will receive no further intervention. Long-term follow up will be for 24 months after completing the 16 week intervention period. Subjects will include 200 women (four groups of 50), 25 to 65 years old with a confirmed diagnosis of FMS. Participants will undergo blinded assessment at the Beth Israel Deaconess Medical Centers GCRC at five time points-baseline, completion of the 16-week intervention and 6, 12 and 24 month follow up. We will assess health and functional status (FIQ, SF36), symptom severity (FIQ, SF36, Beck scales), self-efficacy (Arthritis Self-Efficacy Scale), fitness (muscle strength, cardiovascular fitness, flexibility) and health care utilization (direct and indirect costs). The study will improve treatment outcomes for persons with FMS by identifying the optimal self-management program.

描述（由申请人提供）：纤维肌痛综合征（FMS）是常见的慢性肌肉骨骼疾病以及越来越多的残疾原因增加医疗保健利用。当前治疗主要关注药理干预措施，通常无法改善症状和功能状态。最近的研究表明疾病自我管理在减轻症状严重程度并改善的短期内可以有效在具有FMS的人身上发挥作用。 FMS自我管理的最常见形式是应对技能，培训（行为/教育）和锻炼。数量有限，大多数FMS自我管理研究都检查了一种形式或另一个，大多数使用应对技能培训方法。很少的数据存在用于检查这些干预措施的长期影响的潜力将应对技能培训与全面的团体相结合的加性效果锻炼计划或促进长期遵守这些的方法干预措施。该提案的目的是让PI获取新健康行为领域的能力；扩大研究技能；然后在研究中应用这些知识以确定Fivis的最佳方法自我管理。 PI将结合健康和社会中的正式学习行为，研究设计和分析以及临床研究中的道德非正式学习，在指导下经过验证的学术培训环境中忠实的导师。该研究是一项比较的随机对照试验应对技能培训（关节炎基金会纤维肌痛自助课程（FSHC））带有全面的锻炼计划（PI的先前工作），一个组合（FSHC加上练习计划）或没有治疗（等待名单控制）。每个干预期将持续16周，包括小组由训练有素的人员领导的会议。受试者将在6个月后遵循完成干预措施以评估每个程序的短期效果。在6个月时，受试者将被随机分为两个组 - 一组将接收每6个月的原始干预措施的4周复习课程，其他小组将不接受进一步的干预。长期随访将是完成16周干预期后的24个月。受试者会包括200名妇女（四个50组），25至65岁，并确认诊断FMS。参与者将在贝丝（Beth）接受盲目评估以色列女执事医疗中心在五个时间点 - 贝斯琳，完成在16周的干预和6、12和24个月的随访中。我们将评估健康与功能状态（FIQ，SF36），症状严重程度（FIQ，SF36，Beck 尺度），自我效能感（关节炎自我效能量表），健身（肌肉力量，心血管健身，灵活性）和医疗保健利用率（直接和间接费用）。该研究将改善治疗结果通过确定最佳自我管理计划，具有FMS的人。