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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02403336

Enrollment

356

Registered

2015-03-31

Start date

2014-10-31

Completion date

2017-04-30

Last updated

2017-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perimenopausal Women

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.

Interventions

OTHERTraining health professionals

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

BEHAVIORALBehavioral group intervention

Intervention on patients (educational workshop).

OTHERUsual clinical practice

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Quality of Life	24 months	SF-12 questionnaire

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026