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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Menopause Hormone Replacement Therapy Behavioral: Hormone Replacement Therapy Decision-Aid Not Applicable

Detailed Description:

Background:

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.

Objectives:

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.

Methods:

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.

Status:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
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

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Arms and Interventions
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Arm Intervention/treatment
Arm 1 Behavioral: Hormone Replacement Therapy Decision-Aid


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   45 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- postmenopausal as defined by: Amenorrhea for 12 months or FSH greater than or equal to 25

Exclusion Criteria:

  • unable to speak English
  • are assessed not to have capacity for making medical decisions for their own care
  • had alcohol or drug abuse issues in past 6 months before baseline visit
  • personal history of breast cancer, active liver disease, active vascular thrombosis, and/or active unexplained vaginal bleeding
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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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
More Information
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Publications of Results:

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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00012909    
Other Study ID Numbers: PCC 98-039
First Posted: March 16, 2001    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: November 2007
Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs