NCT Number: NCT07606027
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.
Trial opening soon.
Get Notified19 year–50 year
Female
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Mridula Ghotane, MPH
CONTACT
Sajid Shahul, MD, PhD
CONTACT
University of Nebraska
Other
Postpartum Remote Monitoring and Integration of Mobile Health With Engagement From Community Health Workers for Regulating Elevated Blood Pressure
Acronym: PRIME CARE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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