Health Education in Perimenopausal Women to Promote Self-care and Quality of Life
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Quality of Life [24 months]
SF-12 questionnaire
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lorena LOPEZ-CASTAÑON | Moralzarzal | Madrid | Spain | 28411 |
Sponsors and Collaborators
- Gerencia de Atención Primaria, Madrid
- Instituto de Salud Carlos III
- Fondo de Investigacion Sanitaria
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PI/1100693