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Behavioral Intervention

Patient Education Pamphlet and Partner Sheet for Postpartum Depression (HOME Trial)

N/A

Recruiting

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-30 days postpartum

Awards & highlights

HOME Trial Summary

This trial aims to help Black women at high risk for poor outcomes after giving birth. They want to reduce the number of emergency room visits or readmissions within the first 30 days after delivery. Participants

Who is the study for?

This trial is for postpartum Black women aged 18 or older who have recently delivered at the Hospital of University of Pennsylvania. Participants must speak English, be able to read, and meet certain risk criteria as determined by a prediction model.Check my eligibility

What is being tested?

The study aims to reduce emergency department visits/readmissions within the first 30 days after childbirth. It tests whether providing a pamphlet and access to a patient navigator can improve postpartum care quality and service accessibility for high-risk individuals.See study design

What are the potential side effects?

Since this intervention involves educational materials and support services rather than medical treatments, there are no direct side effects associated with drugs or procedures. However, participants may experience varying levels of satisfaction or stress relief.

HOME Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-30 days postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-30 days postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-30 days 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

Emergency Department (ED) Visits and Readmissions

Secondary outcome measures

Ability to Obtain Needed Services

Depressive Symptoms

HOME Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Patient Education Pamphlet and Partner SheetExperimental Treatment1 Intervention

The study intervention consists of a patient education pamphlet and partner sheet (physically and virtually accessible) that will educate and prepare post-partum participants about health conditions (hypertension, diabetes, and depression), important health behaviors , physical and emotional postpartum symptoms, teach self-management skills, enhance social support, and connect post-partum participants with community resources. The education materials will provide simple actions that participants can utilize to address symptoms, realistic time frames for healing, danger signs to look out for and contact their physicians, and a list of resources for specific issues. The patient navigator will spend approximately 20 minutes with participants after enrollment, in the hospital. Following discharge, the patient navigator will contact each patient between 4 and 20 times, by phone and/or text with a research phone, to address questions and link participants to medical and community resources.

Group II: Standard Postpartum CareActive Control1 Intervention

These patients will receive Standard postpartum care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HOME

2014

N/A

~330

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,069 Total Patients Enrolled

3 Trials studying Postpartum Depression

200 Patients Enrolled for Postpartum Depression

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,636 Total Patients Enrolled

3 Trials studying Postpartum Depression

464 Patients Enrolled for Postpartum Depression

Columbia UniversityOTHER

1,433 Previous Clinical Trials

2,447,045 Total Patients Enrolled

Frequently Asked Questions

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

Are new patients currently being enrolled in this ongoing medical study?

"As per clinicaltrials.gov, this research endeavor is presently seeking suitable participants. The study was first made public on February 20th, 2024 and last updated on February 28th of the same year."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical research study?

"Yes, data from clinicaltrials.gov shows that this research is presently seeking eligible participants. The trial was initially listed on February 20th, 2024 and underwent its latest update on February 28th, 2024. A total of 214 individuals are sought for enrollment at a single designated site."

Answered by AI

Can individuals such as myself participate in this clinical study?

"The trial seeks 214 individuals aged between 18 and 55, exhibiting maternal conduct. Moreover, eligible participants must fulfill the subsequent requirements: Postpartum patients who have given birth at the Hospital of University of Pennsylvania, Aged 18 years or more, Self-identified as Black (indicated in records), Proficient in English language and literacy skills, Additional traits determined by our risk forecast model (algorithm)."

Answered by AI

Can individuals who are older than 45 years be considered for participation in this research study?

"To be eligible for this research, individuals aged between 18 and 55 are sought. There are a total of 26 trials targeting those below 18 years old and 56 studies focused on participants above the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk

Elizabeth Howell 2024. "Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06276647.

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