Observational Study for the Assessment of Quality of Life Related to Health in Users of the Spa of Fitero (Navarra).
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- HAQ (Health Assessment Questionnaire)-Disability of rheumatic patients
研究概览
简要总结
Hypothesis: The spa therapy treatment could improve health-related quality of life (HRQOL) in subjects with knee and/or hip osteoarthritis, and patients with rheumatoid arthritis.
Main objective: Analyze if HRQOL in patients with knee and/or hip osteoarthritis, and patients with rheumatoid arthritis is modified by spa therapy treatment in the spa of Fitero (Spain).
Design: Prospective observational study Participants: Fitero's spa users aged between 45-80 years old, diagnosed with knee and/or hip osteoarthritis, and also with rheumatoid arthritis. At least 40 patients of each type will be included in the study. Participants must be receiving a treatment of at least ten days.
Main Variable: The scores obtained in the Euroqol5Dimensions-5Levels questionnaire (EQ-5D-5L) (for all subjects), the Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC) questionnaire, for subjects with knee and/or hip osteoarthritis, and the Health Assessment Questionnaire (HAQ), for subjects with rheumatoid arthritis.
Other variables: sociodemographic, anthropometric, clinics, and related with spa treatment.
Follow-up duration: 9 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed arthrosis of knee or hip and/or rheumatoid arthrosis
- •balneotherapy treatment of at least 10 days.
- •physically and mentally able to complete questionnaires
排除标准
- •have followed a balneotherapy treatment in the six previous month
结局指标
主要结局
HAQ (Health Assessment Questionnaire)-Disability of rheumatic patients
时间窗: From 1st March 2019 to 1st December 2019
Health Assessment Questionnaire (HAQ) assays the disability of rheumatic patients to carry out daily life activities. The questionary consists on 20 daily life questions, grouped in 8 areas, each one containing two or three questions related to daily life activities. Each question is scored from 0-3. 0 means "done without difficulties" (no disability), 3 score is "impossible to do" (completely disabled). The average of all responses is done. Average scores from 0-1 represent "mild to moderate difficulty", 1-2 means "moderate to severe disability", 3-2 indicates "severe to very severe disability".
WOMAC
时间窗: From 1st March 2019 to 1st December 2019
Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC)
次要结局
未报告次要终点