Development and Evaluation of a Hormone Replacement Therapy Decision-Aid

Menopause Clinical Trial

Official title:

Development and Evaluation of a Hormone Replacement Therapy Decision-Aid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00012909
• Other study ID #: PCC 98-039
• Status: Completed
• Phase: N/A
• First received: March 14, 2001
• Last updated: April 6, 2015
• Est. completion date: March 2004

Study information

• Verified date: November 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hormone Replacement Therapy
• Menopause

Intervention

Behavioral:
• Hormone Replacement Therapy Decision-Aid

Locations

Country	Name	City	State
United States	Edward Hines Jr. VA Hospital, Hines, IL	Hines	Illinois
United States	William S. Middleton Memorial Veterans Hospital, Madison, WI	Madison	Wisconsin
United States	Clement J. Zablocki VA Medical Center, Milwaukee, WI	Milwaukee	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schapira MM, Gilligan MA, McAuliffe TL, Nattinger AB. Menopausal hormone therapy decisions: insights from a multi-attribute model. Patient Educ Couns. 2004 Jan;52(1):89-95. — View Citation