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Behavioural Intervention

Telemedicine for Postpartum Complications (IMPACT Trial)

N/A

Recruiting

Led By David B Nelson, 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

Must not have

Patients with a primary language other than English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks and 1 year postpartum

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My primary language is not English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment, 6 weeks, 1 year postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment, 6 weeks, 1 year postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment, 6 weeks, 1 year postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge

Secondary study objectives

Diastolic Blood Pressure

Edinburgh Postnatal Depression Scale

Generalized Anxiety Disorder 7

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met