Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy (PRIME CARE)
19. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
404
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Sajid Shahul, MD, PhD
- Telefonnummer: 773-398-2956
- E-post: sshahul@unmc.edu
Studer Kontakt Backup
- Navn: Mridula Ghotane, MPH
- Telefonnummer: 445-260-9532
- E-post: mghotane@unmc.edu
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Aktiv 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood Pressure Control (BP <130/80 mmHg)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient Activation Measure (PAM-13)
Tidsramme: 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)
Tidsramme: 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.
|
|
Trust in Physician Scale
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Sajid Shahul, MD, PhD, Department of Anesthesia, University of Nebraska Medical Center, Omaha, NE, USA
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
30. juni 2031
Studiet fullført (Antatt)
30. juni 2031
Datoer for studieregistrering
Først innsendt
8. mai 2026
Først innsendt som oppfylte QC-kriteriene
19. mai 2026
Først lagt ut (Faktiske)
26. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Graviditetskomplikasjoner
- Hypertensjon
- Hypertensjon, Graviditet-indusert
- Health Services Administration
- Helsevesenets kvalitet, tilgang og evaluering
- Kvalitet på helsehjelpen
- Kvalitetsindikatorer, helsehjelp
- Standard for omsorg
Andre studie-ID-numre
- 0312-26-EP
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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