Development and Evaluation of a Hormone Replacement Therapy Decision-Aid
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|ClinicalTrials.gov Identifier: NCT00012909|
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Menopause Hormone Replacement Therapy||Behavioral: Hormone Replacement Therapy Decision-Aid||Not Applicable|
The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HT) 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 HT CD-ROM decision-aid in improving the decision making process for women considering the use of estrogen HT.
The objectives of the study are to: 1) develop a model of the decision-making process for postmenopausal women considering hormone (HT), based on Multi-Attribute Utility Theory (MAUT); 2) produce an interactive CD-ROM decision-aid for HT; 3) evaluate the effect of the interactive CD-ROM decision-aid on patient satisfaction with decision (SWD) and knowledge about menopause and HT; and 4) test the effect of the interactive CD-ROM decision-aid on women�s decisions regarding use of HT.
Phase I (completed) used structured interviews and surveys in the development of a decision model for HT. In phase II, an interactive CD-ROM decision-aid was developed and a randomized controlled trial (RCT) of its effect on decision processes was conducted. Postmenopausal women, aged 45-74 were recruited from the primary care clinics of the four participating Veterans Affairs hospitals: Milwaukee, Madison, Chicago-Hines, and Chicago-Westside. The primary hypothesis was that women who use the CD-ROM decision-aid would demonstrate increased satisfaction with their decision regarding hormone replacement therapy use compared to women receiving the control intervention.
Enrollment and follow-up assessments have been completed. The study is in the analysis phase. The study was presented to the VA HSR&D Combined Monitoring Board on February 5, 2003 and the committee voted unanimously to recommend continuation of the trial. The study has had one publication and several scientific abstract presentations.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Evaluation of a Hormone Replacement Therapy Decision-Aid|
|Actual Study Completion Date :||March 2004|
|Arm 1||Behavioral: Hormone Replacement Therapy Decision-Aid|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00012909
|United States, Illinois|
|Edward Hines Jr. VA Hospital, Hines, IL|
|Hines, Illinois, United States, 60141-5000|
|United States, Pennsylvania|
|Clement J. Zablocki VA Medical Center, Milwaukee, WI|
|Milwaukee, Pennsylvania, United States, 53295-1000|
|United States, Wisconsin|
|William S. Middleton Memorial Veterans Hospital, Madison, WI|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Marilyn M. Schapira, MD MPH||Clement J. Zablocki VA Medical Center, Milwaukee, WI|
|Principal Investigator:||Arneda Van White, MD||Edward Hines Jr. VA Hospital, Hines, IL|