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

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.

Study Overview

• Status: Completed
• Conditions: Perimenopausal Women
• Intervention / Treatment: Other: Training health professionals; Behavioral: Behavioral group intervention; Other: Usual clinical practice

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 Type: Interventional
• Enrollment (Actual): 356
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Moralzarzal, Madrid, Spain, 28411
      • Lorena LOPEZ-CASTAÑON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gerencia de Atención Primaria, Madrid
• Collaborators: Fondo de Investigacion Sanitaria; Instituto de Salud Carlos III

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: August 3, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: PI/1100693