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HERE: Health Empowerment and Resources After Pregnancy (HERE)

8 luglio 2026 aggiornato da: Boston Medical Center

HERE: Health Empowerment and Resources After Pregnancy A Pilot Randomized Controlled Trial of Patient Navigation to Improve Linkage to Primary Care After Hypertensive Disorders of Pregnancy

This study will examine whether a patient navigation program can help improve long-term heart health among people who experienced high blood pressure disorders during pregnancy at Boston Medical Center (BMC). Conditions such as preeclampsia and other hypertensive disorders of pregnancy increase a person's risk of developing cardiovascular disease later in life. However, many patients do not receive timely follow-up care after pregnancy, especially once routine postpartum care ends.

about 60 participants will be randomly assigned to one of two groups. One group will receive standard care, which includes clinician-directed counseling about cardiovascular risk and recommendations for follow-up care. The other group will receive support from a patient navigator in addition to standard care. Patient navigators, also known as Community Wellness Advocates (CWAs), are trained staff who help patients connect with health services, understand their health risks, and navigate the healthcare system.

The main goals of the study are to determine whether this navigation program is practical to implement and acceptable to patients and healthcare providers. Researchers will also examine whether the program improves follow-up with primary care, cardiovascular risk assessment, and engagement in heart-healthy behaviors. Information will be collected from medical records, surveys, and interviews with participants and healthcare staff. Participants will be followed for one year

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02118

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Gave birth at Boston Medical Center (BMC) in the past 2 months
  • Diagnosis of ≥1 hypertensive disorder of pregnancy during their most recent pregnancy
  • Active prescription for ≥1 antihypertensive medication
  • Scheduled for follow-up in the postpartum bridge clinic at BMC
  • Planning to continue using Boston Medical Center for their health care
  • Able and willing to provide informed consent and contact information in English, Spanish, or Haitian Creole (CWA will use hospital interpreter services as needed to communicate with patients with a language preference other than English)

Exclusion Criteria:

  • Diagnosed with cardiovascular disease
  • Planning pregnancy in next 3 months
  • Planning to move out of Massachusetts within the postpartum year

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Postpartum patient navigation
Participants randomized to this intervention arm will receive longitudinal patient navigation from a Community Wellness Advocate (CWA) who will provide ongoing support after discharge at ~6-8 weeks post partum from the perinatal remote blood pressure monitoring (RBPM) program.
Altro: Longitudinal patient navigation
A Community Wellness Advocate (CWA) will provide longitudinal patient navigation-proactive check-ins, assistance with appointment attendance scheduling and planning, identification of barriers to care, follow-up after missed appointments, mental health and social needs screening, and connections to appropriate resources. The CWA will serve as a consistent point of contact throughout the postpartum year.
Comparatore attivo: Standard of care
Participants randomized to this control arm will continue with standard care for a year after discharge from the hospital's perinatal RBPM program at ~6-8 weeks postpartum.
Altro: Standard care
Standard care includes education on postpartum hypertension, a blood pressure cuff for self-monitoring, and assistance with scheduling follow-up care, including referral to a postpartum bridge clinic in General Internal Medicine.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Acceptability of the intervention
Lasso di tempo: 4-6 and 12 months postpartum
Acceptability, the perception among stakeholders that the intervention is agreeable, will be measured using the 4-item Acceptability of Intervention Measure. Responses will be collected on a 5-point Likert scale (1-5), and the total score will range from 4-20. Total score will be evaluated as a continuous outcome with higher scores indicating greater acceptability. Results will be separately analyzed among participants, navigators, and other clinical staff.
4-6 and 12 months postpartum
Feasibility of the intervention
Lasso di tempo: 4-6 and 12 months postpartum
Feasibility, the extent to which the intervention can be carried out, will be measured using the 4-item Feasibility of Intervention Measure. Responses will be collected on a 5-point Likert scale (1-5), and the total score will range from 4-20. Total score will be evaluated as a continuous outcome with higher scores indicating greater feasibility.
4-6 and 12 months postpartum
Fidelity of the intervention- Penetration
Lasso di tempo: monthly for 12 months postpartum
Penetration or "reach" is defined as the percentage of eligible individuals who were screened. This fidelity related metric will be assessed using a protocol-based checklist and electronic health record data for reference monthly
monthly for 12 months postpartum
Fidelity of the intervention- Adherence
Lasso di tempo: monthly for 12 months postpartum
Adherence is defined as the percentage of enrolled participants who were supported by the navigator. This fidelity related metric will be assessed using a protocol-based checklist and electronic health record data for reference monthly.
monthly for 12 months postpartum

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participation Satisfaction
Lasso di tempo: 4-6 and 12 months postpartum
Satisfaction will be measured using the 18-item Patient Satisfaction Questionnaire (PSQ-18). Each item is rated on a 5-point Likert scale (strongly agree to strongly disagree), and items are grouped into 7 dimensions of care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Each dimension is measured by 2-4 items. After reverse-coding negatively worded items, we will calculate the mean response score (1-5) for each dimension, with higher scores indicating greater satisfaction with care.
4-6 and 12 months postpartum
Linkage to Primary Care
Lasso di tempo: 4-6 and 12 months postpartum
The measure will be the percentage of participants with a completed primary care visit, excluding Bridge clinic appointments, occurring between >6 weeks and 1 year postpartum.
4-6 and 12 months postpartum
Cardiovascular Health (CVH)
Lasso di tempo: 2, 4-6, and 12 months postpartum
CVH will be defined using the American Heart Association's Life's Essential 8 construct, which scores each of 8 domains from 0 to 100 and generates an overall CVH score as the unweighted average of the 8 component scores (0 = worst, 100 = best heart health). The 8 components of CVH are- diet, physical activity, sleep, nicotine exposure, body mass index, blood lipids, blood glucose, and blood pressure. Diet, physical activity, sleep, and nicotine exposure will be assessed by self-report via survey. Body mass index, blood lipids, blood glucose, and blood pressure will be drawn from the electronic health record (using values closest to the assessment window), and EHR-documented tobacco use will corroborate self-reported nicotine exposure. Each domain subscore (0-100) will be calculated per Life's Essential 8 and generate the overall CVH score as the unweighted average of the 8 domains.
2, 4-6, and 12 months postpartum
Cardiovascular Disease (CVD) Risk Assessment
Lasso di tempo: 12 months postpartum
Cardiovascular disease risk assessment will be defined as completion of both glycemic control testing (OGTT or A1c) and lipids testing between >6 weeks and 1 year postpartum. This will be assessed from the electronic health record based on completed lab testing.
12 months postpartum
Patient Activation
Lasso di tempo: 2, 4-6, and 12 months postpartum
Patient activation, a composite measure of knowledge, skills, and confidence to become actively engaged in one's own health care, will be assessed using the 10-item Consumer Health Activation Index (CHAI). Scores range from 0-100 and are categorized as follows: 0-79 = Low activation; 80-94 = Moderate activation; 95-100 = High activation.
2, 4-6, and 12 months postpartum
Bridge Clinic Attendance
Lasso di tempo: 2, 4-6, and 12 months postpartum
The measure will be the percentage of participants with a completed bridge clinic appointment between >6 weeks and 4 months postpartum.
2, 4-6, and 12 months postpartum
CVD risk perception
Lasso di tempo: 2, 4-6, and 12 months postpartum
Participants will be asked about their level of concern for their future heart health, on a 4-point scale. Descriptive statistics will be calculated on this outcome as an ordered categorical variable.
2, 4-6, and 12 months postpartum

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boston Medical Center

Collaboratori

National Heart, Lung, and Blood Institute (NHLBI)

Investigatori

  • Investigatore principale: Mara Murray Horwitz, MD, MPH, Boston Medical Center, General Internal Medicine

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2028

Completamento dello studio (Stimato)

1 settembre 2028

Date di iscrizione allo studio

Primo inviato

17 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

14 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • H-46773
  • 1K23HL165097-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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