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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-04-30

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.

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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.

Conditions

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Perimenopausal Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Behavioral group intervention

Professionals: 3 training sessions for updating the knowledge and learning skills. Patients: Health education workshop.

Group Type EXPERIMENTAL

Training health professionals

Intervention Type OTHER

Intervention on the professionals (3 training sessions for updating the knowledge and learning skills) and

Behavioral group intervention

Intervention Type BEHAVIORAL

Intervention on patients (educational workshop).

Usual clinical practice

Professionals: meeting methodological of 30 minutes duration. Patients: Usual clinical practice. Health education individually on nursing consultation.

Group Type ACTIVE_COMPARATOR

Usual clinical practice

Intervention Type OTHER

Professionals: meeting methodological of 30 minutes duration. Patients: Usual clinical practice. Health education individually on nursing consultation.

Interventions

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Training health professionals

Intervention on the professionals (3 training sessions for updating the knowledge and learning skills) and

Intervention Type OTHER

Behavioral group intervention

Intervention on patients (educational workshop).

Intervention Type BEHAVIORAL

Usual clinical practice

Professionals: meeting methodological of 30 minutes duration. Patients: Usual clinical practice. Health education individually on nursing consultation.

Intervention Type OTHER

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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes