Syphilis Video Tool to Promote Knowledge and Testing in t... | NCT00552539

Studies
Syphilis Video Tool to Promote Knowledge and Testing in the ED

NCT00552539

Sponsor

Jacobi Medical Center

Status

Completed

Last Update Posted

Nov 2, 2007Estimated

Enrollment

220Actual

Phase

Not Applicable

Conditions

Syphilis

Interventions

'educational video'

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Not provided

Completion Date

Aug 2006Actual

First Submitted Date

Oct 31, 2007

First Submission Date that Met QC Criteria

Oct 31, 2007

First Posted Date

Nov 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2007

Last Update Posted Date

Nov 2, 2007Estimated

Name	Class
Public Health Solutions	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to determine whether the "Syphilis and Men" educational video can be a useful tool to increase syphilis knowledge and testing among English and Spanish-speaking urgent care and emergency department patients, regardless of various self-reported characteristics that increase their risk for syphilis infection.

Detailed Description

A randomized four-group intervention-control Solomon design was implemented with Group 1 participants receiving a pre-test survey, the educational video intervention, and a post-test survey; Group 2 the pre-test and post-test surveys; Group 3 the video intervention and a post-test survey; and Group 4 the post-test survey. This design was selected to assess the effect of the video in increasing syphilis knowledge while controlling for the influence of the pre-test instrument in potentially sensitizing participants to key facts. A computer-generated randomization list was created and used to assign patients to groups.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	pre test survey, educational video, post test survey	Other: 'educational video'
2	No Intervention	no intervention
3	Experimental	educational video and post test survey	Other: 'educational video'
4	No Intervention	post test survey

Interventions

Name	Type	Description	Arm Group Labels	Other Names
'educational video'	Other	'educational video'	1 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome was the score on a 10-question measure designed to assess knowledge attained from the educational video.		20 minutes

Secondary Outcomes

Measure	Description	Time Frame
A secondary outcome was the decision to be tested for syphilis.		20 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 18-55 years of age were eligible only if they spoke English or Spanish.

Exclusion Criteria:

Patients were excluded if clinically unstable, unarousable, hearing impaired or visually impaired despite corrected lens.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yvette Calderon, MD, MS	Jacobi Medical Center	Principal Investigator
John P Sanchez, MD, MPH	Jacobi Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jacobi Medical Center		The Bronx	New York	10461	United States

Condition Browse Module

MeSH Terms

ID	Term
D013587	Syphilis

Ancestor Terms

ID	Term
D014211	Treponemal Infections
D013145	Spirochaetales Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided