Feasibility of Remote Blood Pressure Monitoring to Improve Management of Hypertensive Disorders of Pregnancy (RBPM)
SH RBPM: Feasibility of Remote Blood Pressure Monitoring to Improve Management of Hypertensive Disorders of Pregnancy
This study represents an innovative approach to hypertensive disorders of pregnancy surveillance by using remote blood pressure monitoring to address the unique challenges of hypertensive disorders of pregnancy management in a predominantly rural state. Transitioning from episodic in-clinic monitoring to continuous, patient-centered monitoring changes how high-risk patients and healthcare providers detect hypertensive episodes and advances the field by establishing clinical effectiveness and feasibility of remote blood pressure monitoring (RBPM), to provide evidence for scaling interventions that improve maternal health.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
This is a prospective study enrolling women who are pregnant or newly postpartum to monitor their blood pressures remotely. Additionally, a retrospective control group will serve as a comparison group that will have clinical data collected from the EMR on patients who had previous hypertensive disorders.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Sophia Connelly, BA
- Telefoonnummer: 605-312-3332
- E-mail: Sophia.Connelly@sanfordhealth.org
Studie Contact Back-up
- Naam: Andrew Williams, PhD, MD
- Telefoonnummer: 701-777-6718
- E-mail: Andrew.D.Williams@und.edu
Studie Locaties
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North Dakota
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Fargo, North Dakota, Verenigde Staten, 58104
- Sanford Health
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Contact:
- Sophia Connelly, BA
- Telefoonnummer: 605-312-3332
- E-mail: Sophia.Connelly@sanfordhealth.org
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Contact:
- Peter VanEerden, MD
- Telefoonnummer: (701) 234-3443
- E-mail: Peter.VanEerden@sanfordhealth.org
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Hoofdonderzoeker:
- Peter VanEerden, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Women aged 18 years or older
- Either currently pregnant or within 10 days postpartum
- Singleton pregnancy
- Diagnosed with a hypertensive disorder during the current or the most recent pregnancy
- Able and willing to provide informed consent
Exclusion Criteria:
- Men will not be included in the study
- Women younger than 18 years of age
- Women with a multiple gestation pregnancy
- Those without a hypertensive disorder of pregnancy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Remote Monitoring Arm
Pregnant or newly postpartum women who are diagnosed with a hypertensive disorder of pregnancy and consent to monitor their blood pressures remotely. |
Participants will take their blood pressure at least twice daily until cleared by their OB, typically at their 6 week post-partum visit. Every time a participant takes their blood pressure, the cuffs will track the blood pressure and allow the participants to review previous blood pressures and document them for their provider. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Remote Blood Pressure Monitoring Adherence using the Homedics 700 Series Arm Blood Pressure Monitor or Equivalent for Women with Hypertensive Disorders of Pregnancy.
Tijdsspanne: Enrollment to 6 week post partum visit
|
Study will determine whether RBPM improves adherence to recommended blood pressure monitoring protocols compared to in clinic monitoring. The study will utilize the Homedics 700 Series Arm Blood Pressure Monitor or equivalent. The monitor will be provided to participants who will be asked to monitor and record their blood pressures at home twice daily (or more if they would like). |
Enrollment to 6 week post partum visit
|
|
Provider and Patient Satisfaction by surveying participants on their experience with remote blood pressure monitoring.
Tijdsspanne: Enrollment to 6 week post partum visit
|
Both participants and participant's primary OB provider will be surveyed on their satisfaction with RBPM. |
Enrollment to 6 week post partum visit
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Peter VanEerden, MD, Sanford Health
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SH RBPM
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
The coded RBPM, EMR derived analytic datasets, and survey files will be stored on an access controlled UND servers, which meets NIH requirements for long term preservation and security. The combined and coded data will be shared with the ICPSR. This is a repository through the University of Michigan. The repository will make this data restricted from the public for the first 3 years, and users would need to request permission and a project proposal to access the data.
IPD-tijdsbestek voor delen
Data will be made available upon approval and publication of any manuscripts.
IPD-toegangscriteria voor delen
Users would need to request permission and a project proposal to access the data.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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