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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Sophia Connelly, BA
- Telefonnummer: 605-312-3332
- E-post: Sophia.Connelly@sanfordhealth.org
Studera Kontakt Backup
- Namn: Andrew Williams, PhD, MD
- Telefonnummer: 701-777-6718
- E-post: Andrew.D.Williams@und.edu
Studieorter
-
-
North Dakota
-
Fargo, North Dakota, Förenta staterna, 58104
- Sanford Health
-
Kontakt:
- Sophia Connelly, BA
- Telefonnummer: 605-312-3332
- E-post: Sophia.Connelly@sanfordhealth.org
-
Kontakt:
- Peter VanEerden, MD
- Telefonnummer: (701) 234-3443
- E-post: Peter.VanEerden@sanfordhealth.org
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Huvudutredare:
- Peter VanEerden, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Remote Blood Pressure Monitoring Adherence using the Homedics 700 Series Arm Blood Pressure Monitor or Equivalent for Women with Hypertensive Disorders of Pregnancy.
Tidsram: 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.
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Peter VanEerden, MD, Sanford Health
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SH RBPM
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
Data will be made available upon approval and publication of any manuscripts.
Kriterier för IPD Sharing Access
Users would need to request permission and a project proposal to access the data.
Läkemedels- och apparatinformation, studiedokument
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