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Fellesskapsbasert implementering av STAC

18. september 2026 oppdatert av: University of Wisconsin, Madison

Samfunnsbasert helsefremmende og forebygging Modifisere å holde seg frisk etter (rundt) fødsel med hypertensjon under graviditet gjennom postpartum

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

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

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 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).

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 cycles and follow-up interviews and surveys for patients (3-5 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 additional PDSA cycles (up to 3).

Step 5: Finalize A-STAC Intervention.

Studietype

Intervensjonell

Registrering (Faktiske)

47

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
        • University of Wisconsin

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: STAC-CAB Members

Staying Healthy After Childbirth - Community Advisory Board members (8-12 members)

Ingen inngripen: Lived Experience Group Members

Lived Experience Group members (8-12 members)

Eksperimentell: PDSA Cycle Participants and CBO Staff

Black pregnant or postpartum persons and Community Based Organization Staff

Conduct PDSA cycles and follow-up interviews and surveys for patients (3-5 per cycle, 10 total) and CBO staff (no less than 2)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Qualitative Summary of Barriers to Implementation of A-STAC
Tidsramme: up to 4 weeks

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
Qualitative Summary of Facilitators to Implementation of A-STAC
Tidsramme: up to 4 weeks

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.

up to 4 weeks
Qualitative Summary of Adaptations to STAC
Tidsramme: up to 8 weeks

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
The Acceptability of Intervention Measure (AIM)
Tidsramme: up to 8 weeks

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.

up to 8 weeks
The Intervention Appropriateness Measure (IAM)
Tidsramme: up to 8 weeks

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.

up to 8 weeks
The Feasibility of Intervention Measure (FIM)
Tidsramme: up to 8 weeks

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.

up to 8 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Kara Hoppe, DO, PhD, University of Wisconsin, Madison
  • Hovedetterforsker: Andrew Garbacz, PhD, University of Wisconsin, Madison

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. mai 2025

Primær fullføring (Faktiske)

28. juli 2026

Studiet fullført (Faktiske)

28. juli 2026

Datoer for studieregistrering

Først innsendt

7. november 2024

Først innsendt som oppfylte QC-kriteriene

13. november 2024

Først lagt ut (Faktiske)

15. november 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2024-1594
  • U48DP006793 (U.S. NIH-stipend/kontrakt)
  • Protocol Approved 5/14/26 (Annen identifikator: UW Madison)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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