Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00526994
Status:
COMPLETED
Last Update Posted:
2013-07-31
First Post:
2007-09-06
Brief Title:
Randomized Controlled Trial of Routine Screening for IPV
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Randomized Controlled Trial of Routine Screening for Intimate Partner Violence
Status:
COMPLETED
Status Verified Date:
2013-07
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:
This is a randomized controlled trial with three arms to establish the impact of screening and referral to services for women disclosing exposure to IPV
Detailed Description:
Approximately 2675 women will be enrolled and randomized to one of 3 arms In the first arm participants will be screened and if disclosing IPV will receive information on available resources in the community In arms two and three participants will not be screened but one group will receive information on available resources in the community and the other will not All three groups will be assessed for quality of life SF-12standardized and validated scale with 12 questions that measure overall health 1 item physical functioning 2 items role limitations due to physical health problems 4 items bodily pain 1 item energyfatigue 1 item social functioning 1 item psychological distress 1 item and well being 1 item in the past 4 weeks items are summed to form a physical health composite scale and a mental health composite scale each scale is standardized to have a mean of 50 and a standard deviation of 10 for the US population with a possible range from 0 to 100 higher scores represent a better health state disability and utilization of health care and IPV services at baseline and at a 12 month follow-up A pilot study also using a randomized controlled trial design will establish the feasibility acceptability and impact on disclosure rates use of referral resources and potential harms of three screening and referral strategies
sample size calculation based n needed to detect a standardized effect size of 03 with an α05 1-tailedand ß20 if theres a 20 IPV rate and 30 lost-to-follow-up rate
sample size calculation based n needed to detect a standardized effect size of 03 with an α05 1-tailedand ß20 if theres a 20 IPV rate and 30 lost-to-follow-up rate
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 200-2006-15969 | None | None | None |
| IRB 4984 | None | None | None |
| IRB 4985 | None | None | None |
| OMB 0920-06BM | None | None | None |
| Contract 200-2008-28219 | None | None | None |