Ignite Creation Date:
2024-05-06 @ 12:03 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01479985
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2011-11-17
Brief Title:
Computerized Contraceptive Decision Aid
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Randomized Clinical Trial of a Computerized Contraceptive Decision Aid
Status:
COMPLETED
Status Verified Date:
2020-09
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:
CDM RCT
Brief Summary:
The purpose of this study is to conduct a randomized clinical trial of a web-based contraceptive decision aid compared to routine contraceptive counseling to evaluate the effect of the contraceptive decision aid on the contraceptive method selected by the participant
The investigators primary hypothesis is that women utilizing a computerized Contraceptive Decision Aid CDA will be more likely to choose highly effective contraception than women who undergo standard clinical contraceptive counseling
The investigators primary hypothesis is that women utilizing a computerized Contraceptive Decision Aid CDA will be more likely to choose highly effective contraception than women who undergo standard clinical contraceptive counseling
Detailed Description:
Our primary specific aim is to test the CDA by conducting a randomized clinical trial comparing the CDA to routine contraceptive counseling Our primary outcome of interest will be selection of highly effective contraception including the intrauterine device IUD the implant and injectable contraception compared to all other reversible contraceptive methods
We will also complete the following secondary specific aims
1 We will use the validated Decisional Conflict Scale to measure decisional conflict pre- and post-intervention and compare the change in decisional conflict score in women randomized to the CDA to women undergoing routine counseling
2 We will also evaluate satisfaction with contraceptive counseling and contraceptive continuation and satisfaction at 3 and 6 months
We will also complete the following secondary specific aims
1 We will use the validated Decisional Conflict Scale to measure decisional conflict pre- and post-intervention and compare the change in decisional conflict score in women randomized to the CDA to women undergoing routine counseling
2 We will also evaluate satisfaction with contraceptive counseling and contraceptive continuation and satisfaction at 3 and 6 months
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