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Development and Evaluation of a Hormone Replacement Therapy Decision-Aid



Development and Evaluation of a Hormone Replacement Therapy Decision-Aid

For Condition: Menopause
Status: Recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Health Services Research and Development Service
Synopsis: The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HRT) is complex because patients must balance the short- and long-term risks and benefits. Information from new and important clinical trials must also be considered. The purpose of this research is to develop and evaluate the efficacy of a HRT CD-ROM decision-aid in improving the decision-making process for women considering the use of estrogen HRT. The objectives of the study are to: 1) develop a model of the decision-making process for women considering estrogen hormone replacement therapy (HRT), based on Multi-Attribute Utility Theory (MAUT); 2) produce an interactive CD-ROM decision-aid for HRT; 3) evaluate the effect of the interactive CD-ROM decision-aid on patient satisfaction with decision (SWD) and knowledge about menopause and HRT; and 4) test the effect of the interactive CD-ROM decision-aid on womenÂ’s decisions regarding initiation of HRT. Phase I (completed) used structured interviews and surveys in the development of a decision model for HRT. In phase II, an interactive CD-ROM decision-aid was developed and a randomized controlled trial (RCT) of its effect on decision processes was initiated. Postmenopausal women, aged 45-74, are being recruited from the primary care clinics of the four participating Veterans Affairs hospitals: Milwaukee, Madison, Chicago-Hines, and Chicago-Westside. The primary hypothesis is that women who use the CD-ROM decision-aid will demonstrate increased satisfaction with their decision regarding hormone replacement therapy use compared to women receiving the control intervention.
Details:
Eligibility:
Study Type:  Interventional, Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment
Minimum Age/Maximum Age: 45 Years/74 Years
Genders: Female
Protocol Entry Criteria: 45 years or older female, Postmenopausal
Total Enrollment: 145

Location and Contact Information:

C. J. Zablocki VA Medical Center *Recruiting*
Milwaukee,  Wisconsin,  53295
United States
Recruiting Marilyn  Schapira 414-384-2000


Additional Information:
Study ID Numbers:  PCC 98-039; 
Study Start Date: October 1999
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012909

Other Menopause Studies:
1. Soy Estrogen Alternative Study (SEA)

2. Alternative Therapies for Menopause: A Randomized Trial

3. Women's Healthy Lifestyle Project: Cardiovascular Risk Factors and Menopause

4. Single-Dose Study of Black Cohosh and Red Clover

5. Black Cohosh Extract in Postmenopausal Breast Health

Related Studies:

Other Menopause Clinical Trials
Other Wisconsin Clinical Trials
Other Milwaukee Clinical Trials

Development and Evaluation of a Hormone Replacement Therapy Decision-Aid
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