Healing at Home 2.0 - Enhanced Chat Tool for Lowering Postpartum Depression

NCT ID: NCT06877104

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-13

Study Completion Date

2026-06-30

Brief Summary

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The purpose of the study is to determine if access to a text-message based holistic chatbot support program "Healing at Home 2.0" decreases depressive symptoms as measured by the Edinburgh Postnatal Depression Scale (EPDS) compared to usual postpartum care for patients of color.

Detailed Description

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Healing at Home (H@H) 2.0 is a comprehensive technology-based postpartum support program which provides 24/7 support to individuals through use of an SMS chatbot for six weeks postpartum. This will be a randomized controlled trial (RCT) with an intervention arm consisting of patients who are planning to be discharged at routine timing (as determined by their clinical team) with access to H@H 2.0 postpartum SMS chatbot platform and a control arm which consists of usual postpartum care.

Conditions

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Depression, Postpartum Postpartum Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard of care

Routine postpartum care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Healing @ Home Program (H@H 2.0)

Routine postpartum care and the use of an algorithm-based text message support program for six weeks.

Group Type EXPERIMENTAL

Healing @ Home Program (H@H 2.0)

Intervention Type OTHER

Healing @ Home 2.0 is a clinically used comprehensive technology-based postpartum support program, which provides 24/7 support to individuals through use of a text message based chatbot for six weeks postpartum. Content of H@H 2.0 includes anticipatory guidance regarding physical recovery, infant care and feeding, clinical algorithms to respond to urgent patient needs.

Interventions

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Healing @ Home Program (H@H 2.0)

Healing @ Home 2.0 is a clinically used comprehensive technology-based postpartum support program, which provides 24/7 support to individuals through use of a text message based chatbot for six weeks postpartum. Content of H@H 2.0 includes anticipatory guidance regarding physical recovery, infant care and feeding, clinical algorithms to respond to urgent patient needs.

Intervention Type OTHER

Other Intervention Names

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Penny the Chatbot H@H 2.0 W2H

Eligibility Criteria

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Inclusion Criteria

* Postpartum patients who have delivered a singleton baby at or after 37w0d at the Hospital of the University of Pennsylvania
* Self-identify as a person of color (listed on chart as non-White race and confirmed with patient)
* Able to speak, read and write English
* Age ≥18
* Prenatal care at outpatient practice affiliated with the Hospital of the University of Pennsylvania
* Completion of clinically administered EPDS during inpatient stay
* Routine discharge timing, day 2 or more after vaginal delivery, day 3 or more after cesarean delivery

Exclusion Criteria

* Unable to provide informed consent
* Baby not discharged with mother at postpartum discharge
* Does not have access to a mobile phone
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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March of Dimes

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Kirstin Leitner

Assistant Professor of Clinical Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kirstin Leitner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Meaghan G McCabe, MPH

Role: CONTACT

973-747-2824

Angelina Malenda

Role: CONTACT

551-482-3655

Facility Contacts

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Angelina Malenda

Role: primary

(551) 482-3655

Other Identifiers

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857508

Identifier Type: -

Identifier Source: org_study_id

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