Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy

NCT07606027 | Not Yet Recruiting DMC

• 1 other identifier: 0312-26-EP
• Study Type: interventional
• Target: 404
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypertensive Disorders of Pregnancy (HDP); Hypertension, Pregnancy Induced; Severe Maternal Morbidity; Postpartum Hypertension

Keywords

Hypertension, Pregnancy-Induced; Postpartum Period; Remote Blood Pressure Monitoring; Community Health Workers; Postpartum Care; African American Women

Outcome Measures

Primary Outcomes (1)

• Blood Pressure Control (BP <130/80 mmHg)

  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

Secondary Outcomes (4)

• Patient Activation Measure (PAM-13)

  At Baseline (6 weeks) postpartum, 6 months postpartum and 12 months (1 year) postpartum

• Morisky Medication Adherence Scale (MMAS-8)

  At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.

• Trust in Physician Scale

  At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.

• Severe Maternal Morbidity (SMM) Composite Rate

  Baseline (6weeks) postpartum to 12 months (1 year) postpartum

Study Arms (2)

Collaborative Care Intervention

EXPERIMENTAL

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.

Other: Collaborative care

Standard Postpartum Care

ACTIVE COMPARATOR

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.

Other: Standard of Care (SOC)

Interventions

Collaborative care OTHER

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.

Collaborative Care Intervention

Standard of Care (SOC) OTHER

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.

Standard Postpartum Care

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nebraska: lead

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MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sajid Shahul, MD, PhD

  Department of Anesthesia, University of Nebraska Medical Center, Omaha, NE, USA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sajid Shahul, MD, PhD

CONTACT

773-398-2956; sshahul@unmc.edu

Mridula Ghotane, MPH

CONTACT

445-260-9532; mghotane@unmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a parallel assignment design to either the collaborative care intervention or standard postpartum care at approximately 6 weeks postpartum. The collaborative care intervention includes remote blood pressure monitoring using a home device and support from community health workers who provide education, care coordination, and assistance with healthcare navigation. The standard care group will receive usual postpartum care along with home blood pressure monitoring. Participants will be followed for 12 months postpartum to assess blood pressure control, clinical outcomes, and patient-reported measures

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share