Back to resultsImproving Patient Understanding of Preeclampsia
Primary Purpose
Preeclampsia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACOG education pamphlet on preeclampsia
Preeclampsia education tool
Sponsored by
About this trial
This is an interventional health services research trial for Preeclampsia focused on measuring Patient understanding and counseling
Eligibility Criteria
Inclusion Criteria:
- 12-40 weeks pregnant
- No significant hearing or vision impairment
- English speaking
Exclusion Criteria:
- Active diagnosis of preeclampsia
- Significant hearing or vision impairment
- Non-English speaking
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Improved understanding of preeclampsia
Understanding of preeclampsia will be assessed through a questionnaire that asks a series of closed ended questions about preeclampsia as well as a single open ended question. This questionnaire has been used in a prior study and has proven to be a useful assessment of patient knowledge.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01119183
Brief Title
Improving Patient Understanding of Preeclampsia
Official Title
Improving Patient Understanding of Preeclampsia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Participants counseled with the preeclampsia educational tool will have a better understanding of preeclampsia than those not counseled using the tool.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
Patient understanding and counseling
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
ACOG education pamphlet on preeclampsia
Intervention Description
The ACOG pamphlet on preeclampsia will be offered to this group
Intervention Type
Behavioral
Intervention Name(s)
Preeclampsia education tool
Intervention Description
The newly created preeclampsia educational tool will be offered to this group
Primary Outcome Measure Information:
Title
Improved understanding of preeclampsia
Description
Understanding of preeclampsia will be assessed through a questionnaire that asks a series of closed ended questions about preeclampsia as well as a single open ended question. This questionnaire has been used in a prior study and has proven to be a useful assessment of patient knowledge.
Time Frame
one week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
12-40 weeks pregnant
No significant hearing or vision impairment
English speaking
Exclusion Criteria:
Active diagnosis of preeclampsia
Significant hearing or vision impairment
Non-English speaking
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22542120
Citation
You WB, Wolf MS, Bailey SC, Grobman WA. Improving patient understanding of preeclampsia: a randomized controlled trial. Am J Obstet Gynecol. 2012 May;206(5):431.e1-5. doi: 10.1016/j.ajog.2012.03.006. Epub 2012 Mar 13.
Results Reference
derived
Learn more about this trial
Improving Patient Understanding of Preeclampsia
We'll reach out to this number within 24 hrs