[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06298214":3,"trial-entities:NCT06298214":92,"trial-summary:NCT06298214":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":39,"sex":53,"minimum_age":54,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":55,"std_ages":70,"locations":74,"central_contacts":84,"overall_officials":85,"references":90,"see_also_links":91},"NCT06298214","RP-23-019","Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester","ENROLLING_BY_INVITATION","2026-06-01","2025-03","2025-03-26","2024-05-29","Elizabeth F Sutton, PhD","OTHER",false,"The goal of this clinical trial is to learn if a program Woman's Hospital has made, called the Her Health Program, can help women be healthy and get healthcare in the first year after having a baby.\n\nThe main question\\[s\\] the study aims to answer are:\n\n* Can the Her Health program increase access to healthcare in the first year postpartum?\n* Can the Her Health program increase knowledge about healthcare and change feelings toward the healthcare system?\n\nParticipants will complete one research visit in which they will be enrolled and told which group they will be in- \"Her Health Program\" group or \"Usual Care\" group. If they are placed in the \"Her Health Program\" group, they will receive their usual care + the addition of an extra healthcare team member(called a community health navigator) to to work with patients and care team for a year postpartum.\n\nResearchers will compare those who receive the Her Health Program and those who do not receive the program to see if the Her Health Program can help women get healthcare in the first year after having a baby.",null,[18,19],"Postpartum","Pregnancy Related",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[24],"NA",{"count":26,"type":27},500,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Her Health Program","Addition of a community health worker navigator to assist subject in navigating their health in the first year postpartum.",[31],[35],{"measure":36,"description":37,"timeFrame":38},"Postpartum visit attendance","Visit attended between 6-12 weeks of delivery (yes\u002Fno)","12 weeks postpartum",[40,44,47,50],{"measure":41,"description":42,"timeFrame":43},"Medical trust","Group-Based Medical Mistrust Scale; scores range from 12-60 with higher scores indicating more mistrust","12 months postpartum",{"measure":45,"description":46,"timeFrame":43},"Health literacy","Rapid Estimate of Adult Literacy in Medicine (REALM); scores 0-66; higher score indicates high literacy",{"measure":48,"description":49,"timeFrame":43},"Self-efficacy","PROMIS General Self-Efficacy; scores range 5-50; higher score indicates higher self-efficacy",{"measure":51,"description":52,"timeFrame":43},"Healthcare costs","total cost of healthcare from Medicaid Claims Database within the first 12 months after delivery","FEMALE","16 Years",{"inclusion":56,"exclusion":62,"raw_text":69},[57,58,59,60,61],"At least 16 years old at the time of consent.","Gave birth within 7 days before randomization","Medicaid enrolled","Address of residence within a disadvantaged area (ADI\\>5).","Clearly understands the study procedures and visit schedule, alternative treatments, and risks involved with the study, and voluntarily agrees to participate by giving verbal and written informed consent",[63,64,65,66,67,68],"Use of private health insurance exclusively","Does not speak English.","Plans to move out of state during the study time period","Unwilling to provide permission to link study records, medical records, and Medicaid and Vital Records Database records.","Unwilling to provide informed consent","Unwilling to be randomized.","Inclusion Criteria:\n\n* At least 16 years old at the time of consent.\n* Gave birth within 7 days before randomization\n* Medicaid enrolled\n* Address of residence within a disadvantaged area (ADI\\>5).\n* Clearly understands the study procedures and visit schedule, alternative treatments, and risks involved with the study, and voluntarily agrees to participate by giving verbal and written informed consent\n\nExclusion Criteria:\n\n* Use of private health insurance exclusively\n* Does not speak English.\n* Plans to move out of state during the study time period\n* Unwilling to provide permission to link study records, medical records, and Medicaid and Vital Records Database records.\n* Unwilling to provide informed consent\n* Unwilling to be randomized.",[71,72,73],"CHILD","ADULT","OLDER_ADULT",[75],{"facility":76,"city":77,"state":78,"zip":79,"country":80,"geoPoint":81},"Woman's Hospital","Baton Rouge","Louisiana","70817","United States",{"lat":82,"lon":83},30.44332,-91.18747,[],[86],{"name":87,"affiliation":88,"role":89},"Elizabeth Sutton, PhD","Woman's Hospital, Louisiana","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":93,"biomarkers":95},[94],"Disorder of puerperium",[],{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]