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Behavioural Intervention

Enhanced Virtual Care for Postpartum Complication (IMPACT Trial)

N/A
Recruiting
Led By Elaine Duryea, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks and 1 year postpartum
Awards & highlights

IMPACT Trial Summary

This trial is comparing two different ways to help new moms who may not have a lot of money or resources. The goal is to find the best way to improve the health of these moms and prevent them

Who is the study for?
This trial is for postpartum women who gave birth to a live infant at Parkland Hospital or Grady Health and are getting care at certain community clinics. They must be 18 or older and able to give informed consent. Women who didn't deliver at these hospitals or don't speak English or Spanish can't join.Check my eligibility
What is being tested?
The study compares two programs designed to help new moms after giving birth, especially those with lower incomes: one provides intensive education on postpartum care, while the other offers enhanced support through virtual visits and online resources.See study design
What are the potential side effects?
Since this trial involves educational and virtual support interventions rather than medications, traditional side effects are not expected. However, participants may experience stress or discomfort related to time commitment or discussing personal health issues.

IMPACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge
Secondary outcome measures
Diastolic Blood Pressure
Edinburgh Postnatal Depression Scale
Generalized Anxiety Disorder 7
+14 more

IMPACT Trial Design

2Treatment groups
Active Control
Group I: Enhanced Virtual CareActive Control1 Intervention
Women in the enhanced virtual care model will receive scheduled telehealth visits on the platform of their choice - either via video or audio-only synchronous visits. Patients in the virtual care model will check vital signs with home devices during the telehealth visit and report them directly to the provider. This "pull" approach to data collection directly contrasts with the "push" approach of comparator #1.
Group II: Intensive EducationActive Control1 Intervention
Women enrolled in the intensive education care model participate in intensive in-person education as well as ongoing virtual education via the electronic health record web portal in the form of strategically timed "pushes" of relevant and digestible educational elements via a "Care Companion." These virtual education "pushes" will include "to do" list reminders to check vital signs and submit them for review to the care team. Positive reinforcement will be provided when tasks are completed.

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,993,958 Total Patients Enrolled
1 Trials studying Postpartum Complication
2,894 Patients Enrolled for Postpartum Complication
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,050,235 Total Patients Enrolled
Elaine Duryea, MDPrincipal InvestigatorUT Southwestern Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enlist patients for this research study?

"According to the information found on clinicaltrials.gov, this particular clinical trial is currently not accepting new participants. The study was first posted on March 1st, 2024 and last updated on January 11th, 2024. However, there are four other ongoing trials actively recruiting candidates at this time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
Elaine Duryea 2024. "IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218355.
All > Paid Studies Atlanta > Fort Worth
~2333 spots leftby Sep 2027
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