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| Name | Class |
|---|---|
| March of Dimes | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | Routine postpartum care. | |
| Healing @ Home Program (H@H 2.0) | Experimental | Routine postpartum care and the use of an algorithm-based text message support program for six weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healing @ Home Program (H@H 2.0) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 3 months postpartum |
| Count of unscheduled emergency room/postpartum triage visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meaghan G McCabe, MPH | Contact | 973-747-2824 | meaghan.mccabe@pennmedicine.upenn.edu | |
| Angelina Malenda | Contact | 551-482-3655 | angelina.malenda@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kirstin Leitner, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D003863 | Depression |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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 |
| Up to 6 weeks postpartum |
| 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. | At baseline and 6 weeks postpartum |
| 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. | At baseline and at 6 weeks postpartum |
| Knowledge of postpartum warning signs | 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 | At baseline and at 6 weeks postpartum |
| Score of Postpartum sleep: quality | One question Likert scale ranking quality of sleep from terrible to excellent. | At baseline and at 6 weeks postpartum |
| Postpartum sleep: hours | Average number of hours slept in the past 7 days. | At baseline and at 6 weeks postpartum |
| Postpartum pain score | 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. | 24 hours prior to discharge from hospital |
| Social support and maternal functioning score | 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. | At 6 weeks postpartum |
| Implementation outcome: Acceptability of Intervention Measure | 4-item Likert scale where scores can range from 4 to 20. High scores indicate higher acceptability. Given to the intervention group only. | At 6 weeks postpartum |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |