Development and Evaluation of a Hormone Replacement Therapy Decision-Aid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00012909
First received: March 14, 2001
Last updated: January 24, 2013
Last verified: November 2007
  Purpose

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 Intervention
Menopause
Hormone Replacement Therapy
Behavioral: Hormone Replacement Therapy Decision-Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Development and Evaluation of a Hormone Replacement Therapy Decision-Aid

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 150
Study Completion Date: March 2004
Arms Assigned Interventions
Arm 1 Behavioral: Hormone Replacement Therapy Decision-Aid

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.

  Eligibility

Ages Eligible for Study:   45 Years to 74 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012909

Locations
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Investigators
Principal Investigator: Marilyn M. Schapira, MD MPH Philadelphia VA Medical Center, Philadelphia, PA
Principal Investigator: Arneda Van White, MD Edward Hines Jr. VA Hospital
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00012909     History of Changes
Other Study ID Numbers: PCC 98-039
Study First Received: March 14, 2001
Last Updated: January 24, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014