跳至主要内容
临床试验/NCT03004911
NCT03004911已完成不适用

Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年2月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire

研究概览

简要总结

The purpose of this study is to test the efficacy of a mobile application named ProFibro to promote self-care, and improve symptoms and health-related quality of life in Brazilian patients with fibromyalgia.

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
19 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of fibromyalgia, according to the 2010 American College of Rheumatology diagnostic criteria
  • smartphone user
  • complete primary education

排除标准

  • being in physical therapy treatment for fibromyalgia or having been treated in the last 3 months
  • diagnosis of other chronic pain conditions (neuropathies, rheumatoid arthritis, osteoarthritis, spinal stenosis or cancer)
  • severe mental disorders (schizophrenia, psychosis, bipolar affective disorder, severe depression)
  • moderate or severe intellectual disability
  • hearing or visual impairment

研究组 & 干预措施

Mobile application

Experimental

干预措施: ProFibro (Mobile application) (Device)

Paper booklet

Active Comparator

干预措施: Paper booklet (Device)

结局指标

主要结局

Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire

时间窗: 6 weeks

Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome.

次要结局

  • Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised(6 weeks)
  • Number of Painful Areas Assessed With the Widespread Pain Index(6 weeks)
  • Severity of Symptoms Assessed With the Symptom Severity Scale(6 weeks)
  • Pain Assessed With the Visual Analogue Scale(6 weeks)
  • Adherence to Mobile Application Assessed by Number of Clicks on the App Functions(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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