ClinicalTrials.Veeva

Menu

Comparing Different Methods of Patient Education on Preeclampsia

Geisinger Health logo

Geisinger Health

Status

Completed

Conditions

Hypertension
Preeclampsia
HELLP
Eclampsia
Anxiety
Pregnancy

Treatments

Other: Graphic card
Other: Video

Study type

Interventional

Funder types

Other

Identifiers

NCT02765906
2016-0116

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

Female

Volunteers

Accepts 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 3 patient groups

No intervention
No Intervention group
Description:
No additional education
Graphic card
Experimental group
Description:
Education with graphic card
Treatment:
Other: Graphic card
Video
Experimental group
Description:
Education with video
Treatment:
Other: Video

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems