[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06689930":3,"trial-entities:NCT06689930":112,"trial-summary:NCT06689930":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":42,"secondary_outcomes":63,"sex":64,"minimum_age":65,"maximum_age":15,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":87,"locations":90,"central_contacts":100,"overall_officials":101,"references":107,"see_also_links":108},"NCT06689930","2024-1594","Community-based Implementation of Adapted STAC","Dissemination and Implementation of a Community-driven Approach to Improve the Health of Women, Infants, and Families: Pre-implementation Phase to Adapt Staying Healthy After Childbirth (STAC)","COMPLETED","2026-07-28","2026-09","2026-09-16","2025-05-22","University of Wisconsin, Madison","OTHER",null,"This study is being done to adapt the Staying Healthy After Childbirth (STAC) intervention for implementation among Black Women and Birthing Persons (WBP).","Hypertensive disorders of pregnancy (HDP) are windows into chronic disease risk. The immediate postpartum (PP) period (6 weeks) is the highest risk and most important period for prevention of serious adverse outcomes with long term consequences. This project focuses on a multicomponent evidence-based intervention, Staying Healthy After Childbirth (STAC) that has been tested in a Midwest academic hospital. The intervention has been shown to be effective at addressing factors associated with health promotion priorities in populations with high levels of health disparities and inequities by increasing access to hypertension (HTN) care in the critical PP window by providing patients a home blood pressure monitor and access to a dedicated healthcare team that provides remote BP surveillance and antihypertensive medication titration. To optimize STAC to prevent and reduce racial disparities in immediate PP morbidity and mortality, deeper engagement with community stakeholders is critical.\n\nThis is a qualitative investigation designed as pre-implementation of the Adapted Staying Healthy After Childbirth (A-STAC) intervention.\n\nSTAC-Community Advisory Board (CAB) members and Lived Experience Group members will provide qualitative data through semi-structured interviews regarding implementation factors of STAC, including priorities for adaptation, barriers and facilitators to implementation, and usability. Rapid qualitative analysis will be used to glean themes from the qualitative data. A second round of semi-structured focus groups using the nominal decision-making process will be conducted to address the revisions to implementation strategies and determine priorities for A-STAC. Next, abbreviated study cycles to test implementation (Plan-Do-Study-Act or PDSA cycles) will take place, with Community Based Organization (CBO) partners and participating Black pregnant persons. After each PDSA cycle, interviews and surveys with patients and staff will be conducted. Rapid qualitative analysis will again be used to gain information about the usability of A-STAC from the focus group; this information will then be used to refine the A-STAC intervention. This process will be repeated for a second PDSA cycle (up to three PDSA cycles total), after which the A-STAC intervention will be finalized for implementation (registered to a separate ClinicalTrials.gov record).\n\nStep 1: Conduct interviews with STAC-CAB members (8-12 members) and Lived Experience Group members (8-12 members) to evaluate implementation factors and priorities for adaptation of STAC.\n\nUse rapid qualitative analysis process to glean implementation strategies.\n\nStep 2: Conduct small focus groups (3-4 participants per group) with STAC-CAB members (8-12 members) and Lived Experience Group members separately using nominal group decision decision making process.\n\nAddress revisions to implementation strategies and priorities for A-STAC.\n\nStep 3: Conduct PDSA cycles and follow-up interviews and surveys for patients (3-5 participants per cycle, 10 total) and CBO staff (at least 2 staff).\n\nStep 4: Incorporate usability data from cycle 1 to refine A-STAC.\n\nRepeat steps 3-4 for additional PDSA cycles (up to 3).\n\nStep 5: Finalize A-STAC Intervention.",[19,20,21,22],"Blood Pressure","Hypertension","Pregnancy Related","Health Equity",[24,25,26,27,19,28],"Prenatal","Post Partum","Hypertensive Disorders of Pregnancy","Remote Patient Monitoring","Community-Based Participation","INTERVENTIONAL","SUPPORTIVE_CARE",[32],"NA",{"count":34,"type":35},47,"ACTUAL",[37],{"type":14,"name":38,"description":39,"armGroupLabels":40},"PDSA Cycles","Conduct PDSA cycles and follow-up interviews and surveys for patients (3-5 per cycle, 10 total) and CBO staff (no less than 2)",[41],"PDSA Cycle Participants and CBO Staff",[43,47,50,54,57,60],{"measure":44,"description":45,"timeFrame":46},"Qualitative Summary of Barriers to Implementation of A-STAC","Barriers to implementation of A-STAC in CBOs will be investigated via qualitative analysis of interviews and focus groups with STAC-CAB members. All feedback regarding barriers will be coded for themes summarized by participant count.","up to 4 weeks",{"measure":48,"description":49,"timeFrame":46},"Qualitative Summary of Facilitators to Implementation of A-STAC","Facilitators to implementation of A-STAC in CBOs will be investigated via qualitative analysis of interviews and focus groups with STAC-CAB members. All feedback regarding facilitators will be coded for themes summarized by participant count.",{"measure":51,"description":52,"timeFrame":53},"Qualitative Summary of Adaptations to STAC","Adaptations to STAC will be analyzed from patient participant interviews and CBO staff participants post-PDSA cycles. Interviews will be coded for themes summarized by count.","up to 8 weeks",{"measure":55,"description":56,"timeFrame":53},"The Acceptability of Intervention Measure (AIM)","The Acceptability of Intervention Measure (AIM) measures intervention acceptability with 4 items ranked on a 5-point Likert-type scale from 1 = Completely Disagree to 5 = Completely Agree. Higher scores indicate higher acceptability.",{"measure":58,"description":59,"timeFrame":53},"The Intervention Appropriateness Measure (IAM)","The Intervention Appropriateness Measure (IAM) measures intervention appropriateness with 4 items ranked on a 5-point Likert-type scale from 1 = Completely Disagree to 5 = Completely Agree. Higher scores indicate higher acceptability.",{"measure":61,"description":62,"timeFrame":53},"The Feasibility of Intervention Measure (FIM)","The Feasibility of Intervention Measure (FIM) measures intervention feasibility with 4 items ranked on a 5-point Likert-type scale from 1 = Completely Disagree to 5 = Completely Agree. Higher scores indicate higher acceptability.",[],"ALL","18 Years",true,{"inclusion":68,"exclusion":79,"raw_text":86},[69,70,71,72,73,74,72,75,76,77,78],"Belong to the STAC-CAB or Lived Experience Group","Aged 18 or older","Staff of CBO participating in PDSA cycle","Aged 18 years or older","Pregnant persons greater than or equal to 24 weeks gestation and prior to delivery or postpartum","Self-Identify as African American or Black","Capable of providing informed consent in English","Can follow M•care System use instructions in English","Have ownership of a functioning and reliable smartphone to upload and use the M•other App","Interested in preventing or managing blood pressure during pregnancy",[80,81,82,83,84,85],"Persistent second or third trimester bleeding at time of enrollment","Premature rupture of membranes in the current pregnancy at time of enrollment","Known unrepaired maternal congenital heart disease requiring surgical correction","Maternal heart failure","Chronic kidney disease specifically requiring dialysis","On greater than two antihypertensive medications at time of enrollment","Inclusion Criteria (Interviews and Focus Groups):\n\n* Belong to the STAC-CAB or Lived Experience Group\n* Aged 18 or older\n\nInclusion Criteria (CBO Staff):\n\n* Staff of CBO participating in PDSA cycle\n* Aged 18 years or older\n\nInclusion Criteria (PDSA-Cycles):\n\n* Pregnant persons greater than or equal to 24 weeks gestation and prior to delivery or postpartum\n* Self-Identify as African American or Black\n* Aged 18 years or older\n* Capable of providing informed consent in English\n* Can follow M•care System use instructions in English\n* Have ownership of a functioning and reliable smartphone to upload and use the M•other App\n* Interested in preventing or managing blood pressure during pregnancy\n\nExclusion Criteria (PDSA-Cycles):\n\n* Persistent second or third trimester bleeding at time of enrollment\n* Premature rupture of membranes in the current pregnancy at time of enrollment\n* Known unrepaired maternal congenital heart disease requiring surgical correction\n* Maternal heart failure\n* Chronic kidney disease specifically requiring dialysis\n* On greater than two antihypertensive medications at time of enrollment",[88,89],"ADULT","OLDER_ADULT",[91],{"facility":92,"city":93,"state":94,"zip":95,"country":96,"geoPoint":97},"University of Wisconsin","Madison","Wisconsin","53792","United States",{"lat":98,"lon":99},43.07305,-89.40123,[],[102,105],{"name":103,"affiliation":13,"role":104},"Kara Hoppe, DO, PhD","PRINCIPAL_INVESTIGATOR",{"name":106,"affiliation":13,"role":104},"Andrew Garbacz, PhD",[],[109],{"label":110,"url":111},"STAC Web Page","https:\u002F\u002Fwww.obgyn.wisc.edu\u002Fstac",{"nct_id":4,"conditions":113,"biomarkers":115},[20,114],"Toxemia of Pregnancy",[],{"nct_id":4,"found":66,"summary":117,"prompt_version":127},{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This study is an interventional study with a planned enrollment of 46 participants. It is a qualitative investigation focused on understanding the implementation of an adapted intervention.","completed","Community-based Implementation of Adapted STAC for Blood Pressure in Pregnancy","This study is looking at how to best adapt and implement the Staying Healthy After Childbirth (STAC) program for Black women and birthing persons. STAC is an intervention that provides a home blood pressure monitor and access to a healthcare team to help manage high blood pressure (hypertension) after childbirth. The goal is to understand what helps and what makes it difficult to put this program into practice, and what changes are needed to make it work well for this community. This study is currently unclear on its recruitment status and plans to enroll 46 participants. Success will be measured by understanding the barriers, facilitators, and necessary adaptations to the STAC program.","The study will gather information on barriers and facilitators to implementation for up to 4 weeks, and adaptations to STAC for up to 8 weeks.",112,"If you are a patient, you would participate in interviews and surveys as part of PDSA cycles (Plan-Do-Study-Act, a method for improving processes). These cycles involve 3-5 patients each, for a total of 10 patients.","Not stated in the trial record.",[],"v2"]