Does Menopause Matter?

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Rachel Hess, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00097994
First received: December 1, 2004
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to follow a woman's progression through menopause in order to examine the effects on health related quality of life and use of health care resources, and to understand how women are using alternative therapies.


Condition
Menopause

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Menopause Matter?

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Health Related Quality of Life Score [ Time Frame: Baseline survey ] [ Designated as safety issue: No ]
    The average enrollment scores of the dependent variable HRQOL [the physical and mental component summaries (PCS and MCS) of the SF-36] will be compared among women at different stages of menopause using ANOVA. If the HRQOL scores are not normally distributed on the original scale, a transformation is necessary. We will examine the association between both the baseline presence and severity of symptoms (0-4) and HRQOL using regression techniques. The association between the use of HT (yes/no) and HRQOL will be analyzed by ANOVA. The association between the use of CAM and HRQOL will be analyzed by ANOVA. The association between attitudes towards menopause and HRQOL will be analyzed by linear regression. Confounders, including age, comorbid medical conditions, and social support, will be included in the models. A final model examining the impact of all factors on HRQOL will be created using stepwise linear regression.


Secondary Outcome Measures:
  • Menopause Management [ Time Frame: Menopausal Status Schema designed from STRAW and SWAN At least yearly Study Questions Menopausal Symptoms Vaginal dryness and hot flashes At least yearly Study Questions HRQOL SF-36 At least yearly CIF Social Support ISEL Yearly Study Questions Attitudes ] [ Designated as safety issue: No ]
    We will record all methods used by women in the cohort to manage menopause. Methods will be categorized as use of: no method, HT, and CAM. A frequency table will quantify use of each method as well as type of CAM. We will analyze the relationship between both menopausal symptoms and attitudes towards menopause and methods used by Chi-square or contingency table tests.


Other Outcome Measures:
  • Relationship between HSU and our independent variables, HRQOL and menopausal stage at assessment. [ Time Frame: Physician visits Hospitalizations Prescriptions With each HRQOL assessment Electronic Medical Record (MARS) abstraction as well as subject self-report Intrusiveness of Menopausal Symptoms Year 2 assessment and yearly Study Questions Sleep ] [ Designated as safety issue: No ]

    Using regression analysis techniques, we will examine the relationship between HSU and our independent variables, HRQOL and menopausal stage at assessment. The model will also adjust for confounders such as age and the number and type of comorbidities at the time of analysis. Because all women in the study cohort will have utilization data for at least one physician visit, we will use a linear regression model. If cost data are not normally distributed, we will apply appropriate transformations.

    We will calculate the concordance correlation coefficient to investigate correlation between HSU data extracted from MARS and that obtained by direct patient interview to uncover under-reporting in the MARS database.



Enrollment: 732
Study Start Date: December 2004
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Menopause affects every woman as she ages, yet every woman's experience is different. We are seeking to enroll 720 women from the University of Pittsburgh's Division of General Internal Medicine Outpatient practice (GIMO) at all stages of menopause (pre-, peri-, and post-menopausal), between 40 and 65 years old. They will be followed for 5 years as they progress through menopause.

Women will complete yearly questionnaires during their usual doctor's visit (or by phone or online if necessary) regarding general health, menopause and menopausal symptoms, health related quality of life, traditional and alternative therapy use, social support, and attitudes towards menopause and aging.

We will combine this information with information from women's medical charts to look at how menopause and health related quality of life impact the use of health care resources. Additionally, some women may be asked about the use of health care resources, such as doctor's visits, hospitalizations and lab tests.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women from the University of Pittsburgh's Division of General Internal Medicine Outpatient practice (GIMO)

Criteria

Inclusion Criteria:

  • Women ages 40-65
  • Patients in the University of Pittsburgh General Internal Medicine Oakland Practice
  • Able to complete the Functional Assessment Screening Tablet (a touch-screen survey)

Exclusion Criteria:

  • Refusal to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097994

Locations
United States, Pennsylvania
UPMC General Internal Medicine Oakland
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Rachel Hess, MD, MSc UPMC General Internal Medicine-Oakland
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rachel Hess, MD, MS, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00097994     History of Changes
Other Study ID Numbers: AG0010, 1K23AG024254-01, STRIDE
Study First Received: December 1, 2004
Last Updated: May 19, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Menopause
Quality of Life
Health Services
Complementary Therapies

ClinicalTrials.gov processed this record on October 01, 2014