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Recruiting NCT06877104

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

No phase Interventional Depression, Postpartum Postpartum Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Healing @ Home Program (H@H 2.0).
Who it may be relevant to
Registry conditions: Depression, Postpartum, Postpartum Care. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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.

Interventions

  • Other 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.

Primary outcome measures

  • Edinburgh Postnatal Depression Scale (EPDS) Screening Score [Time frame: At 6 weeks postpartum]
Secondary outcome measures (10)
  • Postpartum visit attendance [Time frame: Up to 3 months postpartum]
  • Count of unscheduled emergency room/postpartum triage visits [Time frame: Up to 6 weeks postpartum]
  • Mode of feeding [Time frame: At baseline and 6 weeks postpartum]
  • Scores of self-efficacy in infant care [Time frame: At baseline and at 6 weeks postpartum]
  • Knowledge of postpartum warning signs [Time frame: At baseline and at 6 weeks postpartum]
  • Score of Postpartum sleep: quality [Time frame: At baseline and at 6 weeks postpartum]
  • Postpartum sleep: hours [Time frame: At baseline and at 6 weeks postpartum]
  • Postpartum pain score [Time frame: 24 hours prior to discharge from hospital]
  • Social support and maternal functioning score [Time frame: At 6 weeks postpartum]
  • Implementation outcome: Acceptability of Intervention Measure [Time frame: At 6 weeks postpartum]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Hospital of the University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT06877104 · 857508

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗