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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Perimenopausal Women

Intervention / Treatment
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* Other: Training health professionals
* Behavioral: Behavioral group intervention
* Other: Usual clinical practice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral group intervention<br>Professionals: 3 training sessions for updating the knowledge and learning skills. Patients: Health education workshop. | Other: Training health professionals<br>* Intervention on the professionals (3 training sessions for updating the knowledge and learning skills) and<br>Behavioral: Behavioral group intervention<br>* Intervention on patients (educational workshop).<br>|
| Active Comparator: Usual clinical practice<br>Professionals: meeting methodological of 30 minutes duration. Patients: Usual clinical practice. Health education individually on nursing consultation. | Other: Usual clinical practice<br>* Professionals: meeting methodological of 30 minutes duration. Patients: Usual clinical practice. Health education individually on nursing consultation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | SF-12 questionnaire | 24 months |