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NCT06689930 | RECRUITING | Blood Pressure


Community-based Implementation of Adapted STAC
Sponsor:

University of Wisconsin, Madison

Brief Summary:

This study is being done to adapt the Staying Healthy After Childbirth (STAC) intervention for implementation among Black Women and Birthing Persons (WBP).

Condition or disease

Blood Pressure

Hypertension

Pregnancy Related

Health Equity

Intervention/treatment

PDSA Cycles

Phase

NA

Detailed Description:

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. This is a qualitative investigation designed as pre-implementation of the Adapted Staying Healthy After Childbirth (A-STAC) intervention. STAC-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 a Community Based Organization (CBO) partner 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, after which the A-STAC intervention will be finalized for implementation (registered to a separate ClinicalTrials.gov record). Step 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. Use rapid qualitative analysis process to glean implementation strategies. Step 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. Address revisions to implementation strategies and priorities for A-STAC. Step 3: Conduct PDSA cycle and follow-up interviews and surveys for patients (5 participants per cycle, 10 total) and CBO staff (at least 2 staff). Step 4: Incorporate usability data from cycle 1 to refine A-STAC. Repeat steps 3-4 for second PDSA cycle. Step 5: Finalize A-STAC Intervention.

Study Type : INTERVENTIONAL
Estimated Enrollment : 46 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : 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)
Actual Study Start Date : 2025-05-22
Estimated Primary Completion Date : 2026-07
Estimated Study Completion Date : 2026-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria (Interviews and Focus Groups)
  • * Belong to the STAC-CAB or Lived Experience Group
  • * Aged 18 or older
  • Inclusion Criteria (CBO Staff)
    • * Staff of CBO participating in PDSA cycle
    • * Aged 18 years or older
    • Inclusion Criteria (PDSA-Cycles)
      • * Pregnant persons greater than or equal to 24 weeks gestation and prior to delivery or postpartum
      • * Self-Identify as African American or Black
      • * Aged 18 years or older
      • * 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
      Exclusion Criteria (PDSA-Cycles)
      • * 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

Community-based Implementation of Adapted STAC

Location Details

NCT06689930


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Locations


RECRUITING

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53792

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