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

Perimenopausal Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403336
• Other study ID #: PI/1100693
• Status: Completed
• Phase: N/A
• First received: March 26, 2015
• Last updated: August 3, 2017
• Start date: October 2014
• Est. completion date: April 2017

Study information

• Verified date: August 2017
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Perimenopausal Women

Intervention

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).

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

Locations

Country	Name	City	State
Spain	Lorena LOPEZ-CASTAÑON	Moralzarzal	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid	Fondo de Investigacion Sanitaria, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	SF-12 questionnaire	24 months