Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy (PRIME CARE)
19 maj 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
404
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Sajid Shahul, MD, PhD
- Telefonnummer: 773-398-2956
- E-post: sshahul@unmc.edu
Studera Kontakt Backup
- Namn: Mridula Ghotane, MPH
- Telefonnummer: 445-260-9532
- E-post: mghotane@unmc.edu
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Blood Pressure Control (BP <130/80 mmHg)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient Activation Measure (PAM-13)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Sajid Shahul, MD, PhD, Department of Anesthesia, University of Nebraska Medical Center, Omaha, NE, USA
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
30 juni 2031
Avslutad studie (Beräknad)
30 juni 2031
Studieregistreringsdatum
Först inskickad
8 maj 2026
Först inskickad som uppfyllde QC-kriterierna
19 maj 2026
Första postat (Faktisk)
26 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Graviditetskomplikationer
- Hypertoni
- Hypertoni, graviditetsinducerad
- Administration
- Sjukvårdskvalitet, tillgång och utvärdering
- Hälsovårdskvalitet
- Kvalitetsindikatorer, hälsovård
- Vårdstandard
Andra studie-ID-nummer
- 0312-26-EP
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