Health Education in Perimenopausal Women to Promote Self-care and Quality of Life: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 356
- 试验地点
- 2
- 主要终点
- Quality of Life
研究概览
简要总结
Objective: To evaluate the efficiency of a group intervention opposite to the usual care to improve the quality of life, measured with the SF-12 questionnaire, in women between 45-55 years to the primary health care centres.
详细描述
Methods: clinical controlled trial with parallel groups, random assignment of primary care units and blinded evaluation of principal label.
Setting: study in primary health care centres (PHCCs) of Madrid Health Service and Castilla León Health Service.
Subjects: Women between 45-55 years to medical consultation in primary care. Intervention: application of good clinical practice procedure and cognitive - behavioural grupal intervention.
Sample size: N=355 patients. Data: Principal response variables: quality of life measured with the SF-12 questionnaire. Secondary response Variables: visits number, medicine /month number, and transitory disability days. Other prognosis and descriptive variables.
Data analysis: Main effectiveness will be analyzed by comparing the improvement in 4 or more points in the SF-12 Mental Health area at 6, 12, 18 y 24 months post- intervention, between intervention and control group. Logistic regression will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect, recorder will be taken in account in this analysis. All statistical tests will be performed with intention to treat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •45-55 years women
- •users of the Health Center
- •able to follow the demands of the study: does not have the intention to move from home in the next 24 months
- •have ability to read and write the Spanish language and agreeing to participate by giving their informed consent in writing.
排除标准
- •Women immobilized at home, with mental disorder or cognitive impairment and/or sensory impairments that prevent to participate in a group intervention.
结局指标
主要结局
Quality of Life
时间窗: 24 months
SF-12 questionnaire
次要结局
未报告次要终点