Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Location contact
Angelina Malenda
CONTACT
Kirstin Leitner, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06877104
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Angelina Malenda
CONTACT
Kirstin Leitner, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Penny the Chatbot, H@H 2.0, W2H
Time frame: At 6 weeks postpartum
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: Up to 3 months postpartum
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 6 weeks postpartum
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: At baseline and 6 weeks postpartum
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 at 6 weeks postpartum
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 postpartum
Using a question from the Pregnancy Risk Assessment measure survey (PRAMS) to ask patients to identify warning signs of complications that can occur after birth
Time frame: At baseline and at 6 weeks postpartum
One question Likert scale ranking quality of sleep from terrible to excellent.
Time frame: At baseline and at 6 weeks postpartum
Average number of hours slept in the past 7 days.
Time frame: 24 hours prior to discharge from hospital
Scores from a 10-item question from the validated Brief Pain Inventory short form will be calculated using Likert scale scoring criteria with scores ranging from 0-100. Higher scores mean higher pain.
Time frame: At 6 weeks postpartum
Scores from the validated Barkin Index of Maternal Functioning tool will be calculated using Likert scale scoring criteria for each of the 20 questions. The total score ranges from 0 to 120, with a score of 120 representing perfect functioning.
Time frame: At 6 weeks postpartum
4-item Likert scale where scores can range from 4 to 20. High scores indicate higher acceptability. Given to the intervention group only.
Contact information is provided by the study sponsor or research team.
Angelina Malenda
CONTACT
Meaghan G McCabe, MPH
CONTACT
University of Pennsylvania
Other
Acronym: HEALED
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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