Hypertension, Pregnancy Induced, Hypertensive Disorders of Pregnancy (HDP), Postpartum Hypertension, Severe Maternal Morbidity
Conditions
Keywords
Hypertension, Pregnancy-Induced, Postpartum Period, Remote Blood Pressure Monitoring, Community Health Workers, Postpartum Care, African American Women
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.
Interventions
OTHERCollaborative care
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.
OTHERStandard of Care (SOC)
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.
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
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
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Control (BP <130/80 mmHg) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Activation Measure (PAM-13) | 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). |
| Morisky Medication Adherence Scale (MMAS-8) | 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. |
| Trust in Physician Scale | 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). |
| Severe Maternal Morbidity (SMM) Composite Rate | 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. |
Contacts
CONTACTSajid Shahul, MD, PhD
CONTACTMridula Ghotane, MPH
PRINCIPAL_INVESTIGATORSajid Shahul, MD, PhD
Department of Anesthesia, University of Nebraska Medical Center, Omaha, NE, USA
Outcome results
None listed