Development and Evaluation of a Hormone Replacement Therapy Decision-Aid

• ClinicalTrials.gov Identifier: NCT00012909
• Recruitment Status: Completed
• First Posted: March 16, 2001
• Last Update Posted: April 7, 2015
• Sponsor: US Department of Veterans Affairs
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information

• First Submitted Date: March 14, 2001
• First Posted Date: March 16, 2001
• Last Update Posted Date: April 7, 2015
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Development and Evaluation of a Hormone Replacement Therapy Decision-Aid
• Official Title: Development and Evaluation of a Hormone Replacement Therapy Decision-Aid
• 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label)

Condition

• Menopause
• Hormone Replacement Therapy

• Intervention: Behavioral: Hormone Replacement Therapy Decision-Aid

Study Arms

Arm 1

Intervention: Behavioral: Hormone Replacement Therapy Decision-Aid

• Publications *: 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. doi: 10.1016/s0738-3991(02)00266-5.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: June 23, 2005): 150
• Original Enrollment: Same as current
• Actual Study Completion Date: March 2004
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 45 Years to 74 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00012909
• Other Study ID Numbers: PCC 98-039
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
• Original Responsible Party: Not Provided
• Current Study Sponsor: US Department of Veterans Affairs
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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

• PRS Account: VA Office of Research and Development
• Verification Date: November 2007