Healing at Home 2.0 - Enhanced Chat Tool for Lowering Postpartum Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Unable to provide informed consent
Baby not discharged with mother at postpartum discharge
Does not have access to a mobile phone
Trial design
Design model
Parallel
Treatments tested in this trial
Healing @ Home Program (H@H 2.0)
Other interventionHealing @ 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.
Treatment groups
156 Participants
are divided into 2 treatment groupsGroup A: Standard of careNo intervention 0 interventions
Group B: Healing @ Home Program (H@H 2.0)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Edinburgh Postnatal Depression Scale (EPDS) Screening Score
Scores from the validated EPDS screening tool will be calculated using standard scoring criteria for each of the 10 items. A score of 9 or greater or indication of suicide ideation will be used to indicate a positive depression screen.
Time frame
At 6 weeks postpartumSecondary outcomes
1
Postpartum visit attendance
Whether or not the patient attended their routine postpartum visit which should occur around the 6-week postpartum mark. We will accept routine postpartum visits up to 12-weeks postpartum.
Time frame
Up to 3 months postpartum2
Count of unscheduled emergency room/postpartum triage visits
The number of unscheduled visits, reason for visit, whether or not patient was admitted to hospital in the first 6 weeks postpartum will be counted
Time frame
Up to 6 weeks postpartum3
Mode of feeding
Patient asked mode of feeding at two time points. Options are exclusively breastfeeding, formula feeding only, or both breast and formula feeding.
Time frame
At baseline and 6 weeks postpartum4
Scores of self-efficacy in infant care
Scores from the validated Self-efficacy in the Nurturing Role (SENR) tool will be calculated using Likert scale scoring criteria for each of the 16 items. Negative items are reverse-scored such that higher scores on the items always reflect greater self-efficacy.
Time frame
At baseline and at 6 weeks postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
March of Dimes
Collaborator
Source ClinicalTrials.gov