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Development and Evaluation of a Hormone Replacement Therapy Decision-Aid

This study is currently recruiting patients.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs

Purpose

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 women’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.

Condition Treatment or Intervention
Menopause
 Procedure: CD-ROM Based Decision-Aid

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment

Further Study Details: 

Expected Total Enrollment:  145

Study start: October 1999;  Study completion: September 2003

Eligibility

Ages Eligible for Study:  45 Years   -   74 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

45 years or older female, Postmenopausal

Location and Contact Information


Wisconsin
      C. J. Zablocki VA Medical Center, Milwaukee,  Wisconsin,  53295,  United States; Recruiting
Marilyn M. Schapira, MD, MPH  414-384-2000  Ext. 42685    mschap@mcw.edu 

More Information

Study ID Numbers:  PCC 98-039
Record last reviewed:  February 2003
Record first received:  March 14, 2001
ClinicalTrials.gov Identifier:  NCT00012909
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09
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