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Reducing Menopausal Symptoms for Women During Menopause Using Group Education in a Primary Health Care Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852811
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

Tracking Information
First Submitted Date  ICMJE May 26, 2016
First Posted Date  ICMJE August 2, 2016
Last Update Posted Date August 2, 2016
Study Start Date  ICMJE October 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
  • Change in menopause symptoms during baseline to four month follow up. The measurement that be used were The Menopause Rating Scale (MRS). [ Time Frame: from baseline to four month follow up ]
    Primary outcome measure: Change in menopausal symptoms (using the menopause rating scale).
  • Change in depression symptoms during baseline to four month follow up. The measurement that be used was The Montgomery-Asberg Depression Rating Scale (MADRS). [ Time Frame: from baseline to four month follow up ]
    Primary outcome measure: Change in depression score (using the Montgomery-Asberg depression rating scale)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Menopausal Symptoms for Women During Menopause Using Group Education in a Primary Health Care Setting
Official Title  ICMJE Reducing Menopausal Symptoms for Women During Menopause Using Group Education in a Primary Health Care Setting: A Randomized Controlled Trial
Brief Summary The aim of the study is to investigate if group education about the topic menopause to women in PHC can improve women's menopausal symptoms and reduce depression.
Detailed Description

One hundred twenty women will be included in the study. The survey population consists of Swedish-speaking women aged 45-55 years and seek care at Distriktsköterskemottagningen in Skene and at the Antenatal clinic in Svenljunga. The selection is done consecutively.

Method:

Grouping:The women will be randomly allocated to intervention group and control group (60/60).

The intervention:

The project includes the implementation of a total of four equivalent group treatments. Two of the group education will be at Skene Medical center and two Svenljunga Medical center. Group treatments are carried out by the district nurse and midwife in common. Each treatment group includes 15 women. A total of 60 women will thus participate in group education..Each treatment group consists of two information sessions of 2 hours.

The first information contains information about the menstrual cycle, hormonal shift, urogenital symptoms, and information on prevention and health promotion self-care.

The other information currently contains information about cardiovascular risk factors during menopause, relations, mental health, information about depressive symptoms and for preventive measures and health-promoting self-care.

The control group did not obtain any group education or any other intervention.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Menopause
Intervention  ICMJE Other: Group education
Intervention involving two education session with topics common in menopause transition.
Study Arms  ICMJE
  • group education
    To measure improvement of menopause symptoms and depression all participating women answered a baseline questionnaire and a follow-up questionnaire four month later. The questionnaires who were used: The Menopause Rating Scale (MRS) and The Montgomery-Asberg Depression Rating Scale (MADRS). MRS were used for reflecting menopause symptom and MADRS for depression symptoms.
    Intervention: Other: Group education
  • No Intervention: control group
    The control group did not obtain any group education or any other intervention. Women answered at baseline questionnaire and four month later. The questionnaires who were used: The Menopause Rating Scale (MRS) and The Montgomery-Asberg Depression Rating Scale (MADRS). MRS were used for reflecting menopause symptom and MADRS for depression symptoms.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2016)
131
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • female gender, 45 to 55 years of age, comprehension and fluency in the Swedish language.

Exclusion Criteria:

  • that the patient did not any longer want to participate in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02852811
Other Study ID Numbers  ICMJE fou2016
registration number: 041-09 ( Registry Identifier: The Regional Ethical Review Board )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vastra Gotaland Region
Study Sponsor  ICMJE Vastra Gotaland Region
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gun Rembeck, PhD Research and Development Center Södra Älvsborg, Närhälsan, Research and Development, Primary Health Care Region, Västra Götaland, Sweden,
PRS Account Vastra Gotaland Region
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP