Health Promotion for Women With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 2
- 主要终点
- SF36 Subscales
研究概览
简要总结
Women with chronic disabling conditions such as fibromyalgia syndrome (FMS) must manage a wide variety of disease-related, intrapersonal, and environmental demands to maintain their health and quality of life. Engaging in health-promoting behaviors is one strategy recommended to manage disease symptoms and enhance quality of life (USDHHS, 2000). The purpose of this four-year study is to refine and test a theoretically and empirically based intervention to promote the health and well being of women with the chronic disabling condition of fibromyalgia. We hypothesize that women who participate in the "Lifestyle Counts" Intervention will report more greater self-efficacy for health behaviors, more frequent health behaviors and more positive health and quality of life than women in the comparison group.
详细描述
This wellness intervention, originally developed and tested in a randomized clinical trial of women with MS (N=113), resulted in significant improvements in self-efficacy, health behaviors and improvements in pain, social functioning, mental health and emotional role-functioning. The specific aims of this study are to examine the effects of the adapted wellness intervention on self-efficacy, resources, barriers, health behaviors and health outcomes for women with fibromyalgia.
A sample of 160 women with FMS will be recruited to participate in a randomized clinical study to determine the effects of this wellness intervention that includes an eight week health promotion/behavior change component and 3 months of follow-up phone support. Content regarding stress management, lifestyle adjustment, physical activity, nutrition and women's health issues will be presented with an emphasis on the unique adaptations and associated skills required to empower women with the tools for exercising personal control over their health behaviors. The effects of the intervention on outcome variables will be assessed over an 8-month period with measurements at baseline, 2 months (immediately after the educational/skill-building component), 5 months (after 3 months of phone support) and at 8 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Physician verified diagnosis of Fibromyalgia for at least 6 months, age 18 to 75,
- •Able to speak and read English
- •Willing to participate in 8-month intervention study
排除标准
- •Pregnancy
- •Concurrent medical conditions (as judged by their physician) for which changes in diet and exercise would be contraindicated
结局指标
主要结局
SF36 Subscales
时间窗: Baseline, 2 months, 5 months and 8 months
次要结局
- Fibromyalgia Impact Questionnaire(Baseline, 2 months, 5 months, 8 months)
- Health Behaviors - The Health Promoting Lifestyle Questionnaire(Baseline, 2 months, 5 months 8 months)