Does Menopause Matter?
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- UPMC General Internal Medicine Oakland
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Health Related Quality of Life Score
時間枠：Baseline survey
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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.
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Baseline survey
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Menopause Management
時間枠：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
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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.
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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
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Relationship between HSU and our independent variables, HRQOL and menopausal stage at assessment.
時間枠：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
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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. |
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
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Rachel Hess, MD, MSc、UPMC General Internal Medicine-Oakland
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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