Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collaborative care, Standard of Care (SOC).
- Who it may be relevant to
- Registry conditions: Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced, Severe Maternal Morbidity, Postpartum Hypertension. Basic parameters: 19 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Postpartum Remote Monitoring and Integration of Mobile Health With Engagement From Community Health Workers for Regulating Elevated Blood Pressure
Overview
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
- Other Collaborative 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. - Other Standard 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.
Primary outcome measures
- Blood Pressure Control (BP <130/80 mmHg) [Time frame: Baseline (6 weeks) postpartum to 12 months postpartum]
Secondary outcome measures (4)
- Patient Activation Measure (PAM-13) [Time frame: At Baseline (6 weeks) postpartum, 6 months postpartum and 12 months (1 year) postpartum]
- Morisky Medication Adherence Scale (MMAS-8) [Time frame: At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.]
- Trust in Physician Scale [Time frame: At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.]
- Severe Maternal Morbidity (SMM) Composite Rate [Time frame: Baseline (6weeks) postpartum to 12 months (1 year) postpartum]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Anderson LA, Dedrick RF. Development of the Trust in Physician scale: a measure to assess interpersonal trust in patient-physician relationships. Psychol Rep. 1990 Dec;67(3 Pt 2):1091-100. doi: 10.2466/pr0.1990.67.3f.1091. PMID 2084735
- Health IDoP. llinois Maternal Morbidity and Mortality Report: October 2023; 2023 [01082024]. Available from: https://dph.illinois.gov /content/dam/soi/en/web/idph/publications/idph/topics-and-services/life-stages-populations/ maternal-child-family-health-services/maternal-health/mmmr/maternal-morbidity-mortalityreport2023.pdf.
- AHA. Postpartum Systems of Care Recommendations. https://wwwheartorg/-/media/files /professional/quality-improvement/maternal-health/recommendationsformatted. 2024.
- Assistant Secretary for Public Affairs (ASPA) DoHaHSH. Strengthening Maternal Health. Available from: https://www.hhs.gov/healthcare/maternal-health/index.html.
- Roderick J. A. Little DBR. Statistical Analysis with Missing Data 2002.
- Patricia M. Grambsch TMT. Proportional Hazards Tests and Diagnostics Based on Weighted Residuals. Biometrika, Vol 81, No 3 (Aug, 1994), pp 515-526 (12 pages).
- Kaplan EL, & Meier, P. . Nonparametric Estimation from Incomplete Observations. Journal of the American Statistical Association. 1958.
- Cox DR. Regression Models and Life-Tables Journal of the Royal Statistical Society: Series B (Methodological), Volume 34, Issue 2.
Identifiers
NCT: NCT07606027 · 0312-26-EP