Health Education in Perimenopausal Women to Promote Self-care and Quality of Life

Perimenopausal Women Clinical Trial

Official title: Health Education in Perimenopausal Women to Promote Self-care and Quality of Life: Randomized Clinical Trial

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Perimenopausal Women

• NCT number: NCT02403336
• Study type: Interventional
• Source: Gerencia de Atención Primaria, Madrid
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Completion date: April 2017