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

20 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

174

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Jesse Rattan, PhD, MPH, RN
  • Numéro de téléphone: 404-606-3319
  • E-mail: jrattan@uab.edu

Lieux d'étude

  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35233
        • University of Alabama at Birmingham (UAB Women and Infants Center)

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Autre: 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.
Expérimental: 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.
Autre: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Systolic Blood Pressure (SBP)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Diastolic Blood Pressure (DBP)
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Mean Arterial Blood Pressure (MAP)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Alabama at Birmingham

Collaborateurs

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

Les enquêteurs

  • Chercheur principal: Jesse Rattan, PhD, MPH, RN, University of Alabama at Birmingham

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

31 août 2026

Achèvement primaire (Estimé)

30 juillet 2029

Achèvement de l'étude (Estimé)

30 juillet 2030

Dates d'inscription aux études

Première soumission

18 août 2026

Première soumission répondant aux critères de contrôle qualité

18 août 2026

Première publication (Réel)

21 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB-300016824
  • K12AR086524 (Subvention/contrat des NIH des États-Unis)
  • Build Up Trust Challenge Award (Autre subvention/numéro de financement: National Institutes of Health)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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

Critères d'accès au partage IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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