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Mobile Health Program for Post-Preeclampsia Hypertension

14. maj 2026 opdateret af: Malamo Countouris, University of Pittsburgh

Multilevel Mobile Health Program to Improve Hypertension Among Midlife Women After Hypertensive Disorder of Pregnancy

Strategies targeted to optimize hypertension (HTN) control for midlife women after hypertensive disorders of pregnancy (HDP) have not been studied, despite evidence of a critical need. This proposal targets the 10-20 years postpartum as a key time when women have subclinical cardiovascular (CV) sequelae of uncontrolled HTN and are primed for CV prevention interventions. Before proceeding with large-scale intervention trials of a home blood pressure monitoring (HBPM) and coaching intervention following HDP, further pilot testing is necessary. The overarching hypothesis of this proposal is that a new monitoring and treatment paradigm utilizing HBPM combined with a virtual coaching intervention would be better than standard of care for mid-life women with prior HDP who develop HTN. Women will be assigned in an unblinded manner to the intervention or standard of care control group.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Women who had a history of HDP (either gestational HTN or preeclampsia) diagnosed by ACOG guidelines at the time of delivery at Magee-Womens Hospital between 2008 and 2015, thus 10 to 20 years from their index pregnancy complicated by HDP.
  • Evidence of current stage 2 HTN (BP ≥ 140/90 mmHg with or without treatment with antihypertensive medication).

Exclusion Criteria:

  • Known clinical CVD (prior myocardial infarction, stroke, heart failure, or peripheral arterial disease).
  • Males will also be excluded from this study as it focuses on pregnancy related conditions.
  • Children will be excluded as the study is only recruiting people who are 10-20 years postpartum.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Coaching Application + HBPM
A smartphone-based, interactive coaching application designed to enhance adherence to home-based blood pressure monitoring and provide guidance on blood pressure management, patient-facing education, and assistance with modifying behaviors associated with poor blood pressure control. The application is connected to a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 3-month intervention duration and a Bluetooth blood pressure cuff.
Adfærdsmæssigt: Coaching ansøgning
En digital applikation til at give undervisning og støtte til hjemmebaseret blodtryksovervågning.
Adfærdsmæssigt: Hjemmebaseret blodtryksmåling
Enhed til måling af blodtryk i hjemmet med bluetooth-forbindelse til automatisk indsamling.
Aktiv komparator: Enhanced usual care with WebMD
Enhanced usual care participants will receive a smartphone for the 3-month intervention duration and the wireless Bluetooth blood pressure cuff. Through this, enhanced usual care participants will have access to WebMD, a smartphone-based tool for learning about blood pressure and other health conditions. Enhanced usual care participants will also receive a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform.
Adfærdsmæssigt: Hjemmebaseret blodtryksmåling
Enhed til måling af blodtryk i hjemmet med bluetooth-forbindelse til automatisk indsamling.
Andet: WebMD
Smartphone-baseret applikation til sundhedsuddannelse og/eller overvågning.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in systolic blood pressure from baseline to 3 months
Tidsramme: Baseline, 3 Months
Change in home-based systolic blood pressure from baseline to 3 months between the intervention and usual care arms.
Baseline, 3 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in diastolic BP and mean arterial pressure from baseline to 3 months
Tidsramme: Baseline, 3 months
Change in diastolic BP and mean arterial pressure from baseline to 3 months
Baseline, 3 months
Adherence to antihypertensive medications at 3 months and 6 months
Tidsramme: Baseline, 6 months
Adherence to antihypertensive medication from baseline to 6 months between the intervention and usual care arms using Proportion of Days Covered, ranging from 0 to 100%, where higher values indicate superior medication adherence.
Baseline, 6 months
Proportion with BP controlled <130/80 mmHg at 3 months and 6 months
Tidsramme: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Adherence to home blood pressure monitoring
Tidsramme: Baseline, 3 months
Quantification of home blood pressure monitoring during the 3-month intervention phase, ranging from 0 to 100%, where higher values indicate superior adherence.
Baseline, 3 months
Feasibility of study measured using enrollment, survey completion, and retention of participants
Tidsramme: Baseline, 3 Month, 6 Month
Proportions of participants who complete all study visits and surveys out of all participants enrolled in the study
Baseline, 3 Month, 6 Month
Durable change in systolic blood pressure measures at 6 months
Tidsramme: Baseline, 6 months
Durable change in SBP measures at 6 months between intervention and usual care arms
Baseline, 6 months
Durable change in diastolic BP measures at 6 months
Tidsramme: Baseline, 6 months
Durable change in DBP measures at 6 months between intervention and usual care arms
Baseline, 6 months
Blood pressure at 3 months
Tidsramme: Baseline, 3 months
Systolic, diastolic, and mean arterial blood pressure at 3 months
Baseline, 3 months
Blood pressure at 6 months
Tidsramme: Baseline, 6 months
Systolic, diastolic, and mean arterial blood pressure at 6 months
Baseline, 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pittsburgh

Samarbejdspartnere

McKamish Family Foundation

Efterforskere

  • Ledende efterforsker: Malamo Countouris, MD, MS, University of Pittsburgh

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

14. maj 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. oktober 2027

Datoer for studieregistrering

Først indsendt

14. maj 2026

Først indsendt, der opfyldte QC-kriterier

14. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY25070197

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The study team will share all of the individual participant data collected during the trial, after deidentification.

IPD-delingstidsramme

The data will be available 12 months following publication of the primary results of this trial.

IPD-delingsadgangskriterier

Researchers who provide a methodologically sound proposal. Proposals should be directed to the Principal Investigator at countourisme@upmc.edu. To gain access, data requestors will need to sign a data access agreement. Data will be provided directly by the study investigators. Costs associated with producing datasets and analysis will be the responsibility of investigators seeking the data.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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