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Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure (AW2H)

20. august 2026 opdateret af: Jesse Rattan, University of Alabama at Birmingham

Alabama Womb to Heart Solution: A Community-Based Cardiovascular Health Intervention After Hypertension in Pregnancy

High blood pressure during or after pregnancy (such as preeclampsia, gestational hypertension, eclampsia, or Hemolysis, Elevated Liver enzymes, and Low Platelet (HELLP) syndrome) raises a mother's risk of heart disease later in life. Many patients do not return for follow-up care after delivery, missing a key window to protect their heart health. The Alabama Womb to Heart Solution (AW2H) trial will test whether pairing postpartum patients with a trained community health worker (CHW) for 6 months lowers blood pressure compared with usual care.

A total of 174 postpartum patients who had pregnancy-associated hypertension or stage 2 high blood pressure will be randomly assigned (1:1) to usual care or usual care plus the AW2H CHW program. All participants receive education on measuring their own blood pressure and a pregnancy-validated home blood pressure monitor. Participants in the CHW group are also contacted regularly by a CHW for 6 months. CHWs coach home blood pressure monitoring, support taking blood pressure medications as prescribed, encourage heart-healthy habits based on the American Heart Association's Life's Essential 8 (LE8), help schedule a primary care visit, provide mother-baby education (such as safe sleep and immunizations), and offer emotional support.

The main outcome is systolic blood pressure 6 months after enrollment, measured at home with the study-provided monitor while a research coordinator observes in person or by video/phone. The study will also look at diastolic blood pressure and whether participants scheduled a primary care visit. Interviews and focus groups will explore participant, CHW, and provider experiences with the program.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a single-site, two-arm, parallel, randomized controlled efficacy trial conducted at the University of Alabama at Birmingham (UAB), building on the Alabama Womb to Heart Solution (AW2H) feasibility/acceptability pilot (NCT06353256, N=61). Postpartum patients with pregnancy-associated hypertension (gestational hypertension, preeclampsia, eclampsia, hypertension with superimposed preeclampsia, or hemolysis, elevated liver enzymes, and low platelet count [HELLP] syndrome) or stage 2 hypertension (systolic blood pressure [SBP] >=140 mmHg or diastolic blood pressure [DBP] >=90 mmHg) are randomized 1:1 to usual care or usual care plus a 6-month community health worker (CHW) intervention delivered in partnership with ConnectionHealth.

Usual care (both arms) includes brief self-measured blood pressure education, a pregnancy-validated iHealth blood pressure (BP) Cuff Kit (provided through partnership with the Preeclampsia Foundation), and written education on hypertensive disorders of pregnancy and long-term cardiovascular risk. The CHW intervention adds visits or contacts approximately 2 times per week for weeks 1-5, weekly for weeks 6-12, and monthly for weeks 13-26 (in person or virtual), covering home BP monitoring coaching with American College of Obstetricians and Gynecologists (ACOG)-concordant escalation guidance, medication adherence, postpartum and pediatric visit reminders, breastfeeding and contraception counseling, Life's Essential 8 behavior coaching, primary care linkage, mother-baby education, and trauma-informed emotional support.

The primary outcome is mean systolic blood pressure at 6 months post-enrollment (mean of 3 readings taken 1 minute apart with the validated iHealth monitor, following a protocol adapted from the Chronic Hypertension and Pregnancy (CHAP) Maternal Follow-up Study). The trial provides 80% power to detect a 7 mmHg difference in SBP (standard deviation [SD] 14.5, two-sided alpha=0.05) with 138 participants; enrollment of 174 allows for 20% attrition. Analysis follows intent-to-treat principles. Aim 2 comprises qualitative interviews (up to 20 intervention-arm participants) and two focus groups (CHWs/ConnectionHealth leadership; healthcare providers) analyzed thematically to inform future implementation.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

174

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Jesse Rattan, PhD, MPH, RN
  • Telefonnummer: 404-606-3319
  • E-mail: jrattan@uab.edu

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • University of Alabama at Birmingham (UAB Women and Infants Center)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Postpartum patients with pregnancy-associated hypertension (gestational hypertension, preeclampsia, eclampsia, hypertension with superimposed preeclampsia, or hemolysis, elevated liver enzymes, and low platelet count [HELLP] syndrome) or stage 2 hypertension per American College of Cardiology/American Heart Association (ACC/AHA) guidelines (systolic blood pressure [SBP] >=140 mmHg or diastolic blood pressure [DBP] >=90 mmHg) on two separate occasions at delivery-related hospital discharge or during the postpartum period
  • Delivered in the last six weeks at >=14 weeks gestational age, including pregnancy loss
  • 16-56 years old
  • Speaks and writes in English
  • Delivering at University of Alabama at Birmingham (UAB) Hospital

Exclusion Criteria:

  • Declines randomization
  • Does not speak English
  • Currently incarcerated
  • Currently enrolled in other community health worker studies or services

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Usual Care
Cardiovascular disease (CVD)-prevention education before hospital discharge from the delivery-associated hospitalization, including brief self-measured blood pressure (BP) education, a pregnancy-validated iHealth BP Cuff Kit, and written education on hypertensive disorders of pregnancy, long-term cardiovascular risk, and postpartum danger signs.
Andet: Usual postpartum care with self-measured blood pressure education and home blood pressure monitor
Standardized self-measured blood pressure (SMBP) education and a pregnancy-validated iHealth blood pressure (BP) Cuff Kit provided before hospital discharge, plus written educational materials on hypertensive disorders of pregnancy and other adverse pregnancy outcomes, long-term cardiovascular disease (CVD) risk, and postpartum danger signs.
Eksperimentel: Usual Care + Alabama Womb to Heart Solution (AW2H) Community Health Worker Program
Usual care (as in Arm 1) plus enrollment in the Alabama Womb to Heart Solution (AW2H) community health worker (CHW) program for 6 months.
Andet: Usual postpartum care with self-measured blood pressure education and home blood pressure monitor
Standardized self-measured blood pressure (SMBP) education and a pregnancy-validated iHealth blood pressure (BP) Cuff Kit provided before hospital discharge, plus written educational materials on hypertensive disorders of pregnancy and other adverse pregnancy outcomes, long-term cardiovascular disease (CVD) risk, and postpartum danger signs.
Adfærdsmæssigt: Alabama Womb to Heart Solution (AW2H) Community Health Worker (CHW) Program
Six-month community health worker (CHW) program delivered in partnership with ConnectionHealth. Visit/contact frequency: Approximately 2 times/week for weeks 1-5, weekly for weeks 6-12, and monthly for weeks 13-26; visits may be in person or virtual (phone/video). CHWs coach home blood pressure monitoring with American College of Obstetricians and Gynecologists (ACOG)-concordant escalation guidance, reinforce antihypertensive medication adherence, educate on postpartum danger signs and long-term cardiovascular risk, remind about postpartum and pediatric visits, counsel on breastfeeding and contraception, coach on American Heart Association (AHA) Life's Essential 8 behaviors, assist with scheduling and attending a primary care appointment, provide mother-baby guidance (safe sleep, immunizations, developmental milestones), and offer trauma-informed emotional support.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Systolic Blood Pressure (SBP)
Tidsramme: 6 months post-enrollment
Mean systolic blood pressure in mmHg, calculated as the mean of 3 readings taken 1 minute apart using a pregnancy-validated iHealth home blood pressure monitor, following a standardized measurement protocol during an in-person or coordinator-observed virtual visit.
6 months post-enrollment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diastolic Blood Pressure (DBP)
Tidsramme: 6 months post-enrollment
Mean diastolic blood pressure in mmHg, calculated as the mean of 3 readings taken 1 minute apart using the same standardized protocol as the primary outcome.
6 months post-enrollment
Scheduling of a Primary Care Visit
Tidsramme: By 6 months post-enrollment
Proportion of participants with integration into primary care, defined as participant self-report of a scheduled primary care visit.
By 6 months post-enrollment

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Arterial Blood Pressure (MAP)
Tidsramme: 6 months post-enrollment
Mean arterial blood pressure in mmHg, derived from blood pressure readings taken using the same standardized protocol as the primary outcome.
6 months post-enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Alabama at Birmingham

Samarbejdspartnere

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Preeclampsia Foundation
ConnectionHealth

Efterforskere

  • Ledende efterforsker: Jesse Rattan, PhD, MPH, RN, University of Alabama at Birmingham

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. august 2026

Primær færdiggørelse (Anslået)

30. juli 2029

Studieafslutning (Anslået)

30. juli 2030

Datoer for studieregistrering

Først indsendt

18. august 2026

Først indsendt, der opfyldte QC-kriterier

18. august 2026

Først opslået (Faktiske)

21. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB-300016824
  • K12AR086524 (U.S. NIH-bevilling/kontrakt)
  • Build Up Trust Challenge Award (Andet bevillings-/finansieringsnummer: National Institutes of Health)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying published results may be made available to qualified investigators on reasonable request to the Principal Investigator, subject to a data use agreement and any institutional approvals required at the time of the request. Sharing will be limited to uses consistent with the consent provided by participants.

IPD-delingstidsramme

Beginning after publication of the primary study results. Requests will be considered on an ongoing basis thereafter.

IPD-delingsadgangskriterier

Requests should be submitted in writing to the Principal Investigator and will be reviewed on a case-by-case basis. Access requires a data use agreement and any institutional approvals required at the time of the request.

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