A Non-Drug Methodology Study To Explore The Psychometric Properties Of A Daily Diary Of Fatigue Symptoms And To Compare Two Modes Of Administration Of Pain And Sleep Interference Questions For Use With Fibromyalgia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 185
- 试验地点
- 15
- 主要终点
- Daily questions about pain asked using a telephone based system and a hand held diary
研究概览
简要总结
The study has two goals. The first goal of the study is to compare two methods of administering questions about pain and sleep interference. The two methods being compared are a telephone based system and an electronic hand held diary. The second goal of the study is to evaluate a daily diary to evaluate fatigue symptoms in patients with fibromyalgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fibromyalgia using ACR diagnosis
排除标准
- •Other confounding disease including other inflammatory disease, pain and depression
研究组 & 干预措施
Interactive Voice Response System
干预措施: Interactive Voice Response System (IVRS) (Other)
Personal Digital Assisstant
干预措施: Personal Digital Assisstant (PDA) (Other)
结局指标
主要结局
Daily questions about pain asked using a telephone based system and a hand held diary
时间窗: 4 weeks
Daily questions about sleep asked using a telephone based system and a hand held diary
时间窗: 4 weeks
Daily questions about fatigue asked hand held electronic diary
时间窗: 2 weeks
Questionaires about pain, fatigue, function, quality of life, patients impression of change and diary ease of use
时间窗: 4 weeks
次要结局
- Questionaires about sleep, mood and fibromyalgia severity(4 weeks)