Study Results
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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RECRUITING
NA
674 participants
INTERVENTIONAL
2024-05-28
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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MOMs High Touch (MOMs-HT)
Participants randomized to the MOMs-HT arm will receive close clinical and behavioral health monitoring via weekly chats (text or email) using chatbot technology and navigation to timely clinical, behavioral health, and/or social care services by the MOMs team throughout the prenatal and postpartum periods; 12 bi-weekly self-management support telehealth visits with a MOMs care management coordinator (CMC) or registered nurse (RN) during the prenatal period; home blood pressure monitor to measure their blood pressure regularly; Fitbit to track physical activity; and 5 bi-weekly telehealth visits with navigation to clinical, behavioral, and social services as needed by the MOMs team up to 6 weeks postpartum.
Northwell Pregnancy & Peds Chats
The Northwell Pregnancy \& Peds Chats is a personalized care digital chatbot delivered via the Conversa platform. At Northwell, patients are enrolled automatically to receive the chats when they initiate prenatal care. Chats are accessible on a smartphone, tablet, and computer. During the prenatal and postpartum periods, participants receive a weekly chat via text message or email with a link to the platform. Each chat begins with asking if there are any updates the patient wants to share regarding their pregnancy. The chats provide timely, brief educational tools and resources. They are also designed to capture clinical, behavioral health, and social health concerns that triggers yellow flags (e.g., lack of transportation to obstetrics appointment) or red flags (e.g., elevated blood pressure) that go to a 24/7 nurse-led call center who follows up to connect the participant to clinical, behavioral health, or social services as needed.
Prenatal Telehealth Visits
The MOMs CMC/RN (interventionists) will deliver up to 12 bi-weekly self-management support telehealth visits during the prenatal period. The first telehealth visit will be 30-45 minutes in duration and follow-up visits will be 15-20 minutes. These telehealth visits will involve clinical and behavioral health check-ins; navigation to clinical, behavioral health, and social services as needed; screening for social needs during the initial telehealth visit; follow-up on referrals to resources to address social needs; and self-management support. MOMs CMCs/RNs will assess progress with engagement in self-management behaviors including asking about minutes and type of physical activity, self-monitoring (blood pressure, blood sugar, weight), and taking medications. The MOMs CMC/RN will provide brief maternal health education and support the participant in establishing behavior change goals and facilitating problem solving to address barriers to achieving goals each session.
Postpartum Telehealth Visits
The MOMs CMC/RN will conduct a telehealth visit (with navigation as needed) by phone 24 and 72 hours after labor and delivery. After the 72-hour call, telehealth visits with navigation will occur bi-weekly until 6 weeks postpartum. These telehealth visits will be 15-20 minutes in duration. Telehealth visits will include a brief clinical and behavioral health check-in, screening for social needs, navigation to clinical, behavioral health, and social services as needed, and follow-up on referrals to community resources and social services. During each visit, participants will be asked if they have experienced any signs or symptoms of concern (e.g., pain, discomfort, headaches, bleeding), screened for depression and anxiety, and be reminded about upcoming medical appointments. The CMC or RN will navigate the participant to the appropriate provider (e.g., OB, cardiologist, behavioral health) or services (e.g., emergency, social, community-based resources) as needed in a timely manner.
Home Blood Pressure Monitor
Participants will receive an Omron 10 home blood pressure monitor to use throughout the study period. Along with the cuff, participants will receive written (postcard) and video instructions (https://youtu.be/p9UEDv6nvwU) on how to accurately measure their blood pressure. Participants with diagnosed chronic hypertension or preeclampsia during the prenatal period will be encouraged to measure their blood pressure twice a day; participants without these conditions will be encouraged to measure their blood pressure twice a week. During the postpartum period, participants will be encouraged to follow their provider recommendations in terms of how often they should measure their blood pressure. Participants will be allowed to keep the blood pressure monitor after the study has completed.
Fitbit
Participants will receive a Fitbit to use during the study period. Participants will be asked to wear the Fitbit on their wrist throughout the day to track all activity (e.g., walking, other physical activity, sedentary activity, and sleep). All data including minutes of activity and step counts will be stored on a secure web-based platform that aggregates data from the Fitbit device. Participants will be encouraged to sync their Fitbit device every 5 days with their phone to ensure data is up to date. Participants will be allowed to keep the Fitbit after the study has completed.
MOMs Low Touch (MOMs-LT)
Participants randomized to the MOMs-LT arm will receive close clinical and behavioral health monitoring via weekly chats (text or email) using chatbot technology and navigation to timely clinical, behavioral health, and/or social care services by the MOMs team throughout the prenatal and postpartum periods; 5 bi-weekly telehealth visits with navigation to clinical, behavioral, and social services as needed by the MOMs team up to 6 weeks postpartum; and a Fitbit to track physical activity.
Northwell Pregnancy & Peds Chats
The Northwell Pregnancy \& Peds Chats is a personalized care digital chatbot delivered via the Conversa platform. At Northwell, patients are enrolled automatically to receive the chats when they initiate prenatal care. Chats are accessible on a smartphone, tablet, and computer. During the prenatal and postpartum periods, participants receive a weekly chat via text message or email with a link to the platform. Each chat begins with asking if there are any updates the patient wants to share regarding their pregnancy. The chats provide timely, brief educational tools and resources. They are also designed to capture clinical, behavioral health, and social health concerns that triggers yellow flags (e.g., lack of transportation to obstetrics appointment) or red flags (e.g., elevated blood pressure) that go to a 24/7 nurse-led call center who follows up to connect the participant to clinical, behavioral health, or social services as needed.
Postpartum Telehealth Visits
The MOMs CMC/RN will conduct a telehealth visit (with navigation as needed) by phone 24 and 72 hours after labor and delivery. After the 72-hour call, telehealth visits with navigation will occur bi-weekly until 6 weeks postpartum. These telehealth visits will be 15-20 minutes in duration. Telehealth visits will include a brief clinical and behavioral health check-in, screening for social needs, navigation to clinical, behavioral health, and social services as needed, and follow-up on referrals to community resources and social services. During each visit, participants will be asked if they have experienced any signs or symptoms of concern (e.g., pain, discomfort, headaches, bleeding), screened for depression and anxiety, and be reminded about upcoming medical appointments. The CMC or RN will navigate the participant to the appropriate provider (e.g., OB, cardiologist, behavioral health) or services (e.g., emergency, social, community-based resources) as needed in a timely manner.
Fitbit
Participants will receive a Fitbit to use during the study period. Participants will be asked to wear the Fitbit on their wrist throughout the day to track all activity (e.g., walking, other physical activity, sedentary activity, and sleep). All data including minutes of activity and step counts will be stored on a secure web-based platform that aggregates data from the Fitbit device. Participants will be encouraged to sync their Fitbit device every 5 days with their phone to ensure data is up to date. Participants will be allowed to keep the Fitbit after the study has completed.
Interventions
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Northwell Pregnancy & Peds Chats
The Northwell Pregnancy \& Peds Chats is a personalized care digital chatbot delivered via the Conversa platform. At Northwell, patients are enrolled automatically to receive the chats when they initiate prenatal care. Chats are accessible on a smartphone, tablet, and computer. During the prenatal and postpartum periods, participants receive a weekly chat via text message or email with a link to the platform. Each chat begins with asking if there are any updates the patient wants to share regarding their pregnancy. The chats provide timely, brief educational tools and resources. They are also designed to capture clinical, behavioral health, and social health concerns that triggers yellow flags (e.g., lack of transportation to obstetrics appointment) or red flags (e.g., elevated blood pressure) that go to a 24/7 nurse-led call center who follows up to connect the participant to clinical, behavioral health, or social services as needed.
Prenatal Telehealth Visits
The MOMs CMC/RN (interventionists) will deliver up to 12 bi-weekly self-management support telehealth visits during the prenatal period. The first telehealth visit will be 30-45 minutes in duration and follow-up visits will be 15-20 minutes. These telehealth visits will involve clinical and behavioral health check-ins; navigation to clinical, behavioral health, and social services as needed; screening for social needs during the initial telehealth visit; follow-up on referrals to resources to address social needs; and self-management support. MOMs CMCs/RNs will assess progress with engagement in self-management behaviors including asking about minutes and type of physical activity, self-monitoring (blood pressure, blood sugar, weight), and taking medications. The MOMs CMC/RN will provide brief maternal health education and support the participant in establishing behavior change goals and facilitating problem solving to address barriers to achieving goals each session.
Postpartum Telehealth Visits
The MOMs CMC/RN will conduct a telehealth visit (with navigation as needed) by phone 24 and 72 hours after labor and delivery. After the 72-hour call, telehealth visits with navigation will occur bi-weekly until 6 weeks postpartum. These telehealth visits will be 15-20 minutes in duration. Telehealth visits will include a brief clinical and behavioral health check-in, screening for social needs, navigation to clinical, behavioral health, and social services as needed, and follow-up on referrals to community resources and social services. During each visit, participants will be asked if they have experienced any signs or symptoms of concern (e.g., pain, discomfort, headaches, bleeding), screened for depression and anxiety, and be reminded about upcoming medical appointments. The CMC or RN will navigate the participant to the appropriate provider (e.g., OB, cardiologist, behavioral health) or services (e.g., emergency, social, community-based resources) as needed in a timely manner.
Home Blood Pressure Monitor
Participants will receive an Omron 10 home blood pressure monitor to use throughout the study period. Along with the cuff, participants will receive written (postcard) and video instructions (https://youtu.be/p9UEDv6nvwU) on how to accurately measure their blood pressure. Participants with diagnosed chronic hypertension or preeclampsia during the prenatal period will be encouraged to measure their blood pressure twice a day; participants without these conditions will be encouraged to measure their blood pressure twice a week. During the postpartum period, participants will be encouraged to follow their provider recommendations in terms of how often they should measure their blood pressure. Participants will be allowed to keep the blood pressure monitor after the study has completed.
Fitbit
Participants will receive a Fitbit to use during the study period. Participants will be asked to wear the Fitbit on their wrist throughout the day to track all activity (e.g., walking, other physical activity, sedentary activity, and sleep). All data including minutes of activity and step counts will be stored on a secure web-based platform that aggregates data from the Fitbit device. Participants will be encouraged to sync their Fitbit device every 5 days with their phone to ensure data is up to date. Participants will be allowed to keep the Fitbit after the study has completed.
Eligibility Criteria
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Inclusion Criteria
* Self-identify as Black/African American or Hispanic/Latina (includes Black + another race; Black or Afro Hispanic/Latina; or Hispanic/Latina),
* Pregnant, less than 17 weeks gestational age,
* OB-CMI risk score ≥ 2 and/or history or preeclampsia,
* English or Spanish as primary language, and
* Receive care at Northwell Health Physician Partners obstetrics practice site.
Exclusion Criteria
If interested in participating in the study, please visit https://www.momschatandcare.com/
18 Years
50 Years
FEMALE
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
Northwell Health
OTHER
Responsible Party
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Principal Investigators
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Stephanie L Fitzpatrick, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Locations
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Northwell Health
Manhasset, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Stephanie L Fitzpatrick, PhD
Role: primary
References
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Fitzpatrick SL, Polo J, Ephraim P, Vrany E, Chiuzan C, Basile M, Friel CP, Moon KC, Silvia E, Bleau H, Nicholson W, Lewis D; MOMs Chat Care Research Group. MOMs Chat & Care Study: Rationale and design of a pragmatic randomized clinical trial to prevent severe maternal morbidity among Black birthing people. Contemp Clin Trials. 2025 May;152:107850. doi: 10.1016/j.cct.2025.107850. Epub 2025 Feb 21.
Other Identifiers
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24-0131
Identifier Type: -
Identifier Source: org_study_id
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