Perimenopausal WomenNCT02403336
Health Education in Perimenopausal Women to Promote Self-care and Quality of Life
A study testing Training health professionals, Behavioral group intervention and Usual clinical practice in people with Perimenopausal Women, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopausal Women
- What is being tested?
- Training health professionals, Behavioral group intervention and Usual clinical practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Women immobilized at home, with mental disorder or cognitive impairment and/or sensory impairments that prevent to participate in a group intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Perimenopausal Women
- Being tested
- Training health professionals, Behavioral group intervention, Usual clinical practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training health professionalsOther
Intervention on the professionals (3 training sessions for updating the knowledge and learning skills) and
Behavioral group interventionBehavioural
Intervention on patients (educational workshop).
Usual clinical practiceOther
Professionals: meeting methodological of 30 minutes duration. Patients: Usual clinical practice. Health education individually on nursing consultation.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral group intervention | Experimental | Professionals: 3 training sessions for updating the knowledge and learning skills. Patients: Health education workshop. Receives: Other: Training health professionals; Behavioral: 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. Receives: Other: Usual clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
SF-12 questionnaire
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimenopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Collaborators
- Instituto de Salud Carlos III, Fondo de Investigacion Sanitaria
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403336
- Sponsor's protocol ID
- PI/1100693
- Status last verified
- Aug 2017
- First submitted
- 26 Mar 2015
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Education in Perimenopausal Women to Promote Self-care and Quality of Life: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02403336
- Acronym / sponsor ID
- PI/1100693
- Conditions
- Perimenopausal Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Collaborators
- Instituto de Salud Carlos III, Fondo de Investigacion Sanitaria
- Study start
- Oct 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral group intervention | Experimental | Other: Training health professionals, Behavioral: Behavioral group interventionProfessionals: 3 training sessions for updating the knowledge and learning skills. Patients: Health education workshop. |
| Usual clinical practice | Active comparator | Other: Usual clinical practiceProfessionals: meeting methodological of 30 minutes duration. Patients: Usual clinical practice. Health education individually on nursing consultation. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Women immobilized at home, with mental disorder or cognitive impairment and/or sensory impairments that prevent to participate in a group intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training health professionalsIntervention on the professionals (3 training sessions for updating the knowledge and learning skills) and | Other | Behavioral group intervention |
| Behavioral group interventionIntervention on patients (educational workshop). | Behavioural | Behavioral group intervention |
| Usual clinical practiceProfessionals: meeting methodological of 30 minutes duration. Patients: Usual clinical practice. Health education individually on nursing consultation. | Other | Usual clinical practice |
Primary outcome
Quality of Life
Time frame: 24 months
SF-12 questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training health professionals, Behavioral group intervention and Usual clinical practice in people with Perimenopausal Women, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.