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Comparing Different Methods of Patient Education on Preeclampsia

Primary Purpose

Preeclampsia, Anxiety, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Graphic card
Video
Sponsored by
Geisinger Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Preeclampsia focused on measuring video, educational tool, preeclampsia, hypertension, pregnancy, patient education, graphic card, eclampsia, HELLP, anxiety, anxiety assessment, STAI 6

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Primiparous pregnant women
  • English speaking
  • Patients at Geisinger Medical Center prenatal clinic
  • Patients at Geisinger Medical Center and Forty Fort Maternal Fetal Medicine clinics

Exclusion Criteria:

  • Multiparous pregnant women
  • Non-English speaking
  • Significant hearing loss/disability
  • Blind or with severe visual impairment
  • Do not have adequate capacity to give consent

Sites / Locations

  • Geisinger Medical Center: Maternal Fetal Medicine and Prenatal Clinics
  • Geisinger Maternal Fetal Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

No intervention

Graphic card

Video

Arm Description

No additional education

Education with graphic card

Education with video

Outcomes

Primary Outcome Measures

Change in percentage of correct responses of preeclampsia knowledge survey score at follow-up assessment
This survey was previously tested in a study by You et al (You WB, Wolf M, Bailey SC, et al. Factors associated with patient understanding of preeclampsia. Hypertension in pregnancy. 2012;31:341.) and found to have a Cronbach alpha of 0.86. The same survey used in a follow up study by You et al (You WB, Wolf MS, Bailey SC, Grobman WA. Improving patient understanding of preeclampsia: a randomized controlled trial. American Journal of Obstetrics & Gynecology. 2012;206:431.e1-431.e5. )

Secondary Outcome Measures

Change in anxiety level after educational intervention as measured by the STAI 6
The Spielberger State-Trait Anxiety Inventory (STAI) is a reliable and sensitive measure of anxiety at a given moment in time. A shorter form, the STAI-6, was created for efficiency and has been verified as comparable in reliability and validity to the full STAI assessment (Marteau, TM and Beckker, H. The development of a six-item short form of the State Scale of the Spielberger State Trait Anxiety Inventory (STAI). British Journal of Clinical Psychology. 1991: 31: 301-306).

Full Information

First Posted
May 5, 2016
Last Updated
July 14, 2020
Sponsor
Geisinger Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02765906
Brief Title
Comparing Different Methods of Patient Education on Preeclampsia
Official Title
Comparing Different Methods of Patient Education on Preeclampsia: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
July 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geisinger Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Preeclampsia is a life-threatening condition unique to pregnancy which occurs in 5-8% of all pregnancies. It contributes to a large proportion of maternal mortality worldwide and these deaths largely result from delayed diagnosis. A number of studies have shown that patient knowledge about preeclampsia is poor and that patient education can improve patient awareness. The investigators would like to find out what type of patient education is most effective. The investigators propose a three arm randomized controlled trial (RCT) where the first arm will receive a graphic card depicting signs and symptoms of preeclampsia, the second arm will watch an educational video on preeclampsia, and the third arm will have no visual form of patient education; they will be exposed only to the counseling they receive with their routine prenatal care. The card and video were both developed by the Preeclampsia Foundation and in a prior RCT the card was shown to be a useful educational intervention. This study would expand on this previous data by comparing the graphic card to an informational video available on the Preeclampsia Foundation's website (http://www.preeclampsia.org/component/allvideoshare/video/featured/7-symptoms-every-pregnant-woman-should-know?Itemid=479). The effectiveness of this video has not yet been tested as an educational tool. Patients in the arm receiving the graphic card for educational intervention will be allowed to keep this card. Primiparous patients seen in the ambulatory prenatal clinic and Maternal Fetal Medicine (MFM) clinic will be enrolled at 18w0d-24w6d gestation. At the time of enrollment baseline preeclampsia knowledge, demographics, and patient anxiety before and after initial exposure to the educational interventions will be assessed. A follow up assessment of knowledge of preeclampsia will be obtained at 32-36 weeks gestation to measure retention of knowledge. Patient medical records will be reviewed for delivery outcomes which will be recorded and compared.
Detailed Description
This is a three-arm prospective randomized controlled trial to evaluate patient knowledge of preeclampsia after different forms of education. In the first arm participants will be given a graphic card depicting signs and symptoms of preeclampsia; they will be permitted to keep this card. In the second arm participants will be shown an educational video on preeclampsia. In the third arm participants will have no visual form of patient education; they will be exposed only to the counseling they receive with their routine prenatal care. Participants will be primiparous patients recruited from the prenatal clinic at 18-24 weeks gestation. At time of consent, baseline anxiety assessment with the STAI-6 questionnaire will be obtained followed by a short demographic survey. Participants will be given a short survey on preeclampsia knowledge. They will then be randomized to either preeclampsia education with educational video, graphic card or no visual educational intervention. The participants will be randomized by computer-generated randomization schema (1:1:1). Those randomized to the card will be given a few minutes to review the card. Those randomized to the educational video will watch the video which runs two minutes and 45 seconds. For those randomized to no further intervention, the initial interview will then be over. For the first two arms receiving the graphic card or watching the video, the STAI 6 assessment will be re-administered immediately after the educational intervention and then the interview will be over. Medical record numbers from every participant will be collected for chart review of demographics, preeclampsia risk factors, pregnancy follow up (including triage calls and visits) and delivery outcomes. The participants will be approached again at 32w0d-36w6d gestation to complete a follow up preeclampsia knowledge survey to assess retention of knowledge. This follow-up survey will be collected via phone interview. Participants in the control arm receiving routine prenatal care will also complete a follow up knowledge survey as a control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia, Anxiety, Hypertension, Pregnancy, Eclampsia, HELLP
Keywords
video, educational tool, preeclampsia, hypertension, pregnancy, patient education, graphic card, eclampsia, HELLP, anxiety, anxiety assessment, STAI 6

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No additional education
Arm Title
Graphic card
Arm Type
Experimental
Arm Description
Education with graphic card
Arm Title
Video
Arm Type
Experimental
Arm Description
Education with video
Intervention Type
Other
Intervention Name(s)
Graphic card
Other Intervention Name(s)
Preeclampsia graphic card
Intervention Description
A randomized controlled trial comparing patient education on preeclampsia with a graphic card vs. patient education with a written pamphlet vs. no patient education showed that patient education improved significantly when patients were provided with a graphic card depicting signs and symptoms of preeclampsia and that this improvement occurred regardless of health literacy score (You WB, Wolf MS, Bailey SC, Grobman WA. Improving patient understanding of preeclampsia: a randomized controlled trial. American Journal of Obstetrics & Gynecology. 2012;206:431.e1-431.e5.). The graphic card is now available on the Preeclampsia Foundation's website (http://www.preeclampsia.org/market-place/educational-illustrated-signs-symptoms-pad-detail).
Intervention Type
Other
Intervention Name(s)
Video
Other Intervention Name(s)
7 Symptoms Every Pregnant Woman Should Know
Intervention Description
This an informational video available on the Preeclampsia Foundation's website (http://www.preeclampsia.org/component/allvideoshare/video/featured/7-symptoms-every-pregnant-woman-should-know?Itemid=479). The effectiveness of this video has not yet been tested as an educational tool.
Primary Outcome Measure Information:
Title
Change in percentage of correct responses of preeclampsia knowledge survey score at follow-up assessment
Description
This survey was previously tested in a study by You et al (You WB, Wolf M, Bailey SC, et al. Factors associated with patient understanding of preeclampsia. Hypertension in pregnancy. 2012;31:341.) and found to have a Cronbach alpha of 0.86. The same survey used in a follow up study by You et al (You WB, Wolf MS, Bailey SC, Grobman WA. Improving patient understanding of preeclampsia: a randomized controlled trial. American Journal of Obstetrics & Gynecology. 2012;206:431.e1-431.e5. )
Time Frame
12-16 weeks
Secondary Outcome Measure Information:
Title
Change in anxiety level after educational intervention as measured by the STAI 6
Description
The Spielberger State-Trait Anxiety Inventory (STAI) is a reliable and sensitive measure of anxiety at a given moment in time. A shorter form, the STAI-6, was created for efficiency and has been verified as comparable in reliability and validity to the full STAI assessment (Marteau, TM and Beckker, H. The development of a six-item short form of the State Scale of the Spielberger State Trait Anxiety Inventory (STAI). British Journal of Clinical Psychology. 1991: 31: 301-306).
Time Frame
5 minutes

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Primiparous pregnant women English speaking Patients at Geisinger Medical Center prenatal clinic Patients at Geisinger Medical Center and Forty Fort Maternal Fetal Medicine clinics Exclusion Criteria: Multiparous pregnant women Non-English speaking Significant hearing loss/disability Blind or with severe visual impairment Do not have adequate capacity to give consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Paglia, MD, PhD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Medical Center: Maternal Fetal Medicine and Prenatal Clinics
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17821
Country
United States
Facility Name
Geisinger Maternal Fetal Medicine
City
Forty Fort
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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
background
PubMed Identifier
21592865
Citation
Firoz T, Sanghvi H, Merialdi M, von Dadelszen P. Pre-eclampsia in low and middle income countries. Best Pract Res Clin Obstet Gynaecol. 2011 Aug;25(4):537-48. doi: 10.1016/j.bpobgyn.2011.04.002. Epub 2011 May 17.
Results Reference
background
PubMed Identifier
21570359
Citation
Tsigas E, Magee LA. Advocacy organisations as partners in pre-eclampsia progress: patient involvement improves outcomes. Best Pract Res Clin Obstet Gynaecol. 2011 Aug;25(4):523-36. doi: 10.1016/j.bpobgyn.2011.03.001. Epub 2011 May 12.
Results Reference
background
PubMed Identifier
15180017
Citation
Ogunyemi D, Benae JL, Ukatu C. Is eclampsia preventable? A case control review of consecutive cases from an urban underserved region. South Med J. 2004 May;97(5):440-5. doi: 10.1097/00007611-200405000-00005.
Results Reference
background
PubMed Identifier
23660041
Citation
Walker MG, Windrim C, Ellul KN, Kingdom JCP. Web-based education for placental complications of pregnancy. J Obstet Gynaecol Can. 2013 Apr;35(4):334-339. doi: 10.1016/S1701-2163(15)30961-0.
Results Reference
background
PubMed Identifier
20860492
Citation
You WB, Wolf M, Bailey SC, Pandit AU, Waite KR, Sobel RM, Grobman W. Factors associated with patient understanding of preeclampsia. Hypertens Pregnancy. 2012;31(3):341-9. doi: 10.3109/10641955.2010.507851. Epub 2010 Sep 22.
Results Reference
background
PubMed Identifier
24216040
Citation
Maimburg RD, Vaeth M, Hvidman L, Durr J, Olsen J. Women's worries in first pregnancy: results from a randomised controlled trial. Sex Reprod Healthc. 2013 Dec;4(4):129-31. doi: 10.1016/j.srhc.2013.10.001. Epub 2013 Oct 9.
Results Reference
background
PubMed Identifier
24481564
Citation
Muller C, Cameron LD. Trait anxiety, information modality, and responses to communications about prenatal genetic testing. J Behav Med. 2014 Oct;37(5):988-99. doi: 10.1007/s10865-014-9555-8. Epub 2014 Jan 31.
Results Reference
background
PubMed Identifier
22492766
Citation
Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012 May;129(5):e1269-74. doi: 10.1542/peds.2011-1702. Epub 2012 Apr 9.
Results Reference
background
PubMed Identifier
1393159
Citation
Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x. Erratum In: Br J Clin Psychol. 2020 Jun;59(2):276.
Results Reference
background
PubMed Identifier
24150027
Citation
Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
Results Reference
background
Links:
URL
http://www.preeclampsia.org/the-news/videos/video/7-symptoms-every-pregnant-woman-should-know
Description
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Comparing Different Methods of Patient Education on Preeclampsia

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