NCT02403336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

2.5 years

First QC Date

March 26, 2015

Last Update Submit

August 3, 2017

Conditions

Perimenopausal Women

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    SF-12 questionnaire

    24 months

Study Arms (2)

Behavioral group intervention

EXPERIMENTAL

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

Other: Training health professionalsBehavioral: Behavioral group intervention

Usual clinical practice

ACTIVE COMPARATOR

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

Other: Usual clinical practice

Interventions

Training health professionalsOTHER

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

Behavioral group intervention
Behavioral group interventionBEHAVIORAL

Intervention on patients (educational workshop).

Behavioral group intervention
Usual clinical practiceOTHER

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

Usual clinical practice

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Women immobilized at home, with mental disorder or cognitive impairment and/or sensory impairments that prevent to participate in a group intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lorena LOPEZ-CASTAÑON

Moralzarzal, Madrid, 28411, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2015

First Posted

March 31, 2015

Study Start

October 1, 2014

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

August 4, 2017

Record last verified: 2017-08

Locations

ES(1)