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

Not Applicable

Completed

• Conditions: Perimenopausal Women
• Interventions: Other: Training health professionals; Other: Usual clinical practice; Behavioral: Behavioral group intervention

• Registration Number: NCT02403336
• Lead Sponsor: Gerencia de Atención Primaria, Madrid

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-03-31
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 356

Inclusion Criteria

• 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.

Exclusion Criteria

• Women immobilized at home, with mental disorder or cognitive impairment and/or sensory impairments that prevent to participate in a group intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral group intervention	Training health professionals	Professionals: 3 training sessions for updating the knowledge and learning skills. Patients: Health education workshop.
Usual clinical practice	Usual clinical practice	Professionals: meeting methodological of 30 minutes duration. Patients: Usual clinical practice. Health education individually on nursing consultation.
Behavioral group intervention	Behavioral group intervention	Professionals: 3 training sessions for updating the knowledge and learning skills. Patients: Health education workshop.

Primary Outcome Measures

Name	Time	Method
Quality of Life	24 months	SF-12 questionnaire

Trial Locations

Locations (1)

Lorena LOPEZ-CASTAÑON; 🇪🇸 Moralzarzal, Madrid, Spain