Clinical trial NCT00097994: Does Menopause Matter?
Official title: Does Menopause Matter?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Keywords: Menopause
Quality of Life
Health Services
Complementary Therapies
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2004-12-02
Enrollment: 732
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women from the University of Pittsburgh's Division of General Internal Medicine Outpatient practice (GIMO)

Brief summary: 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.

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 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

Primary outcomes:
measure: Health Related Quality of Life Score
timeFrame: Baseline survey
Secondary outcomes:
measure: Menopause Management
timeFrame: 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
Other outcomes:
measure: Relationship between HSU and our independent variables, HRQOL and menopausal stage at assessment.
timeFrame: 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
Locations:
city: Pittsburgh
country: United States
facility: UPMC General Internal Medicine Oakland
state: Pennsylvania
Study officials:
affiliation: UPMC General Internal Medicine-Oakland
name: Rachel Hess, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hlatky MA, Boothroyd D, Vittinghoff E, Sharp P, Whooley MA; Heart and Estrogen/Progestin Replacement Study (HERS) Research Group. Quality-of-life and depressive symptoms in postmenopausal women after receiving hormone therapy: results from the Heart and Estrogen/Progestin Replacement Study (HERS) trial. JAMA. 2002 Feb 6;287(5):591-7. doi: 10.1001/jama.287.5.591.
citation: Avis NE, Ory M, Matthews KA, Schocken M, Bromberger J, Colvin A. Health-related quality of life in a multiethnic sample of middle-aged women: Study of Women's Health Across the Nation (SWAN). Med Care. 2003 Nov;41(11):1262-76. doi: 10.1097/01.MLR.0000093479.39115.AF.
citation: Gambacciani M, Ciaponi M, Cappagli B, Monteleone P, Benussi C, Bevilacqua G, Genazzani AR. Effects of low-dose, continuous combined estradiol and noretisterone acetate on menopausal quality of life in early postmenopausal women. Maturitas. 2003 Feb 25;44(2):157-63. doi: 10.1016/s0378-5122(02)00327-4.
citation: Albertazzi P, Purdie D. The nature and utility of the phytoestrogens: a review of the evidence. Maturitas. 2002 Jul 25;42(3):173-85. doi: 10.1016/s0378-5122(02)00024-5.
citation: Thomas S, Ness RB, Thurston RC, Matthews K, Chang CC, Hess R. Racial differences in perception of healthy body weight in midlife women: results from the Do Stage Transitions Result in Detectable Effects study. Menopause. 2013 Mar;20(3):269-73. doi: 10.1097/GME.0b013e31826e7574.