Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012909
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Development and Evaluation of a Hormone Replacement Therapy Decision-Aid
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Development and Evaluation of a Hormone Replacement Therapy Decision-Aid
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womens 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 HSRD 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
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 womens 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 HSRD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None