Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy (PRIME CARE)
19 maja 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Status
Jeszcze nie rekrutacja
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Interwencyjne
Zapisy (Szacowany)
Zapisy
404
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Sajid Shahul, MD, PhD
- Numer telefonu: 773-398-2956
- E-mail: sshahul@unmc.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Mridula Ghotane, MPH
- Numer telefonu: 445-260-9532
- E-mail: mghotane@unmc.edu
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Liczba ramion
2
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Aktywny komparator: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Blood Pressure Control (BP <130/80 mmHg)
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Patient Activation Measure (PAM-13)
Ramy czasowe: 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)
Ramy czasowe: 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.
|
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Trust in Physician Scale
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Sponsor
Śledczy
Śledczy
- Główny śledczy: Sajid Shahul, MD, PhD, Department of Anesthesia, University of Nebraska Medical Center, Omaha, NE, USA
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
1 lipca 2026
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
30 czerwca 2031
Ukończenie studiów (Szacowany)
Ukończenie studiów
30 czerwca 2031
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
8 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
19 maja 2026
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
26 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
26 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
19 maja 2026
Ostatnia weryfikacja
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Choroby naczyniowe
- Choroby układu krążenia
- Choroby układu moczowo-płciowego kobiet i powikłania ciąży
- Powikłania ciąży
- Nadciśnienie
- Nadciśnienie tętnicze wywołane ciążą
- Administracja usług zdrowotnych
- Jakość opieki zdrowotnej, dostęp i ocena
- Jakość opieki zdrowotnej
- Wskaźniki jakości, opieka zdrowotna
- Standard opieki
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 0312-26-EP
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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