Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373367
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Brief Title:
Preeclampsia Educational Program Study PrEPS
Sponsor:
MemorialCare Health System
Organization:
MemorialCare Health System
Study Overview
Official Title:
Preeclampsia Educational Program Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
PrEPS
Brief Summary:
Preeclampsia complicates approximately 8 of all pregnancies A critical factor of outpatient monitoring is patient education specifically education regarding nature of the disease ongoing short- and long-term risks and warning signs and symptoms for worsening of disease This study aims to compare patient knowledge using a novel illustration based app compared to standard discharge instructions
Detailed Description:
Preeclampsia complicates approximately 8 of all pregnancies While many patients improve following delivery the disease process remains a leading cause for postpartum morbidity and mortality A critical factor of outpatient monitoring is patient education specifically education regarding nature of the disease ongoing short- and long-term risks and warning signs and symptoms for worsening of disease There is a gap in the literature regarding effective patient-centered educational tools specifically addressing these elements especially in the postpartum period
We propose a pilot randomized controlled trial of postpartum patients with preeclampsia The intervention of interest is an illustration-based educational mobile device application app focused on the short- and long-term risks associated with preeclampsia and warning signs and symptoms of worsening disease postpartum The control for this study will be the same information in a text-only format also accessed through a mobile device app
Our central hypothesis is that an illustration-based app will improve knowledge of preeclampsia among postpartum patients compared to text-only educational material
Specific Aim 1 Compare the difference in preeclampsia knowledge score from text-only versus illustration-based education 24 hours post intervention short-term We hypothesize that patients who receive illustration-based education will have a higher preeclampsia knowledge scores at 24 hours post-intervention compared to text-only educational materials and b a greater increase in preeclampsia knowledge score from baseline pre-test compared to text-only education
Specific Aim 2 Compare the difference in preeclampsia knowledge score from text-only versus illustration-based education 4 weeks post intervention long-term We hypothesize that patients who receive illustration-based education will have a higher preeclampsia knowledge scores at 4 weeks post-intervention compared to text-only educational materials and b a greater increase in preeclampsia knowledge score from baseline pre-test compared to text-only education
We propose a pilot randomized controlled trial of postpartum patients with preeclampsia The intervention of interest is an illustration-based educational mobile device application app focused on the short- and long-term risks associated with preeclampsia and warning signs and symptoms of worsening disease postpartum The control for this study will be the same information in a text-only format also accessed through a mobile device app
Our central hypothesis is that an illustration-based app will improve knowledge of preeclampsia among postpartum patients compared to text-only educational material
Specific Aim 1 Compare the difference in preeclampsia knowledge score from text-only versus illustration-based education 24 hours post intervention short-term We hypothesize that patients who receive illustration-based education will have a higher preeclampsia knowledge scores at 24 hours post-intervention compared to text-only educational materials and b a greater increase in preeclampsia knowledge score from baseline pre-test compared to text-only education
Specific Aim 2 Compare the difference in preeclampsia knowledge score from text-only versus illustration-based education 4 weeks post intervention long-term We hypothesize that patients who receive illustration-based education will have a higher preeclampsia knowledge scores at 4 weeks post-intervention compared to text-only educational materials and b a greater increase in preeclampsia knowledge score from baseline pre-test compared to text-only education
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None