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Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy (PRIME CARE)

19 de mayo de 2026 actualizado por: University of Nebraska

Postpartum Remote Monitoring and Integration of Mobile Health With Engagement From Community Health Workers for Regulating Elevated Blood Pressure

The goal of this randomized clinical trial is to evaluate the effectiveness of a collaborative care intervention, consisting of remote blood pressure monitoring and support from community health workers, in improving blood pressure control and reducing postpartum complications among Black women with hypertensive disorders of pregnancy (HDP). The primary objectives are to determine whether the intervention leads to improved blood pressure control at 12 months postpartum compared to standard care, and whether it reduces the incidence of serious maternal morbidity, including hospitalizations and cardiovascular events. Secondary objectives include examining whether patient activation and trust in the healthcare system mediate the relationship between the intervention and clinical outcomes. Participants will be enrolled at approximately 6 weeks postpartum and randomized to either the collaborative care intervention or standard postpartum care. All participants will self-monitor blood pressure using a provided device, receive guidance on hypertension management, and complete study assessments at multiple time points. Participants assigned to the intervention arm will additionally receive ongoing support from community health workers, including health education, care coordination, and assistance with healthcare navigation. Clinical outcomes and patient-reported measures will be assessed over a 12-month follow-up period.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

404

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Sajid Shahul, MD, PhD
  • Número de teléfono: 773-398-2956
  • Correo electrónico: sshahul@unmc.edu

Copia de seguridad de contactos de estudio

  • Nombre: Mridula Ghotane, MPH
  • Número de teléfono: 445-260-9532
  • Correo electrónico: mghotane@unmc.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Black/ African American patients
  • Age: 19 and 50 years of age
  • Diagnosis: Hypertension Disorders of Pregnancy
  • Enrolled in STAMPP-HTN for first 6 weeks postpartum

Exclusion Criteria:

  • Age: <19 years
  • Significant Kidney or Liver disease that may limit antihypertensive medication adjustment

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Collaborative Care Intervention
Participants assigned to this arm will receive a collaborative care intervention that includes home blood pressure monitoring using a provided device and support from community health workers. The intervention includes education on hypertension management, assistance with care coordination, and support with healthcare navigation. Participants will regularly measure blood pressure and receive ongoing guidance throughout the 12-month postpartum follow-up period.
Bluetooth-enabled Remote Patient Monitoring (RPM) with algorithm-driven Community Health Worker (CHW) support. CHWs provide support (averaging 2.3 contacts/week) to facilitate medication titration and address social determinants of health. Treatment follows a standardized protocol using guideline-directed medical therapy targeting a blood pressure of <130/80 mmHg.
Comparador activo: Standard Postpartum Care
Participants assigned to this arm will receive standard postpartum care. In addition, participants will be provided with a home blood pressure monitoring device and instructed to measure their blood pressure regularly. No additional community health worker support will be provided.
Traditional clinical management consisting of manual blood pressure monitoring and clinic-based medication titration. Treatment follows the same standardized protocol as the intervention arm, using guideline-directed medical therapy targeting a blood pressure of <130/80 mmHg.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Blood Pressure Control (BP <130/80 mmHg)
Periodo de tiempo: Baseline (6 weeks) postpartum to 12 months postpartum
Primary endpoint - The proportion of patients achieving a target blood pressure of less than 130/80 mmHg. Blood pressure will be analyzed both as a dichotomous variable (normal <130/80 mmHg vs. elevated) and as a continuous variable (mean systolic and diastolic readings).
Baseline (6 weeks) postpartum to 12 months postpartum

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient Activation Measure (PAM-13)
Periodo de tiempo: At Baseline (6 weeks) postpartum, 6 months postpartum and 12 months (1 year) postpartum
Evaluation of survey-based mechanisms of action to determine if they mediate the impact of the Collaborative Care intervention on blood pressure outcome. It assesses patient engagement and activation. A 13-item survey instrument with scores ranging from a minimum of 0 to a maximum of 100. Higher scores indicate a better outcome (greater patient engagement and activation).
At Baseline (6 weeks) postpartum, 6 months postpartum and 12 months (1 year) postpartum
Morisky Medication Adherence Scale (MMAS-8)
Periodo de tiempo: At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
A survey-based mechanism of action evaluated via an 8-item self-report survey scale to determine if it mediates the impact of the Collaborative Care intervention on blood pressure outcome. It measures medication adherence behavior. Scores range from a minimum of 0 to a maximum of 8, where higher scores indicate a better outcome (higher medication adherence). Scores are categorized into low (<6), medium (6 to <8), and high (8) adherence.
At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
Trust in Physician Scale
Periodo de tiempo: At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
An 11-item exploratory survey instrument used to evaluate trust in the health care system and determine if it mediates the impact of the Collaborative Care intervention on blood pressure outcome. Scores range from a minimum of 11 to a maximum of 55, where higher scores indicate a better outcome (greater trust in the healthcare provider).
At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
Severe Maternal Morbidity (SMM) Composite Rate
Periodo de tiempo: Baseline (6weeks) postpartum to 12 months (1 year) postpartum
Composite Endpoint - Incidence rates of severe maternal morbidity events to assess the efficacy of the Collaborative Care model in reducing overall maternal risk. This composite variable tracks the occurrence of any unplanned emergency department (ED) visit, unplanned hospitalization, or the presence of a severe morbidity event. Severe morbidity events are strictly defined as the clinical occurrence of severe hypertension, acute heart failure, pulmonary edema, eclampsia, acute renal failure, shock, sepsis, cardiac arrest, arrhythmias, myocardial infarction, pulmonary embolism, stroke, or death.
Baseline (6weeks) postpartum to 12 months (1 year) postpartum

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Sajid Shahul, MD, PhD, Department of Anesthesia, University of Nebraska Medical Center, Omaha, NE, USA

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

30 de junio de 2031

Finalización del estudio (Estimado)

30 de junio de 2031

Fechas de registro del estudio

Enviado por primera vez

8 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

19 de mayo de 2026

Publicado por primera vez (Actual)

26 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

19 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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