Does Menopause Matter?

NCT00097994 | Completed

• 3 other identifiers: AG00101K23AG024254-01STRIDE
• Study Type: observational
• Target: 732
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Keywords

Menopause; Quality of Life; Health Services; Complementary Therapies

Outcome Measures

Primary Outcomes (1)

• Health Related Quality of Life Score

  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.

  Baseline survey

Secondary Outcomes (1)

• Menopause Management

  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 (1)

• Relationship between HSU and our independent variables, HRQOL and menopausal stage at assessment.

  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

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• Refusal to participate

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Aging (NIA): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

UPMC General Internal Medicine Oakland

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

• 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.

  PMID: 11829697 BACKGROUND

• 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.

  PMID: 14583689 BACKGROUND

• 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.

  PMID: 12590012 BACKGROUND

• 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.

  PMID: 12161041 BACKGROUND

• 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.

  PMID: 23435023 DERIVED

Study Officials

• Rachel Hess, MD, MSc

  UPMC General Internal Medicine-Oakland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MS

Study Record Dates

• First Submitted: December 1, 2004
• First Posted: December 2, 2004
• Study Start: December 1, 2004
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

US (1)