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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sophia Connelly, BA
- 전화번호: 605-312-3332
- 이메일: Sophia.Connelly@sanfordhealth.org
연구 연락처 백업
- 이름: Andrew Williams, PhD, MD
- 전화번호: 701-777-6718
- 이메일: Andrew.D.Williams@und.edu
연구 장소
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North Dakota
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Fargo, North Dakota, 미국, 58104
- Sanford Health
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연락하다:
- Sophia Connelly, BA
- 전화번호: 605-312-3332
- 이메일: Sophia.Connelly@sanfordhealth.org
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연락하다:
- Peter VanEerden, MD
- 전화번호: (701) 234-3443
- 이메일: Peter.VanEerden@sanfordhealth.org
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수석 연구원:
- Peter VanEerden, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Remote Blood Pressure Monitoring Adherence using the Homedics 700 Series Arm Blood Pressure Monitor or Equivalent for Women with Hypertensive Disorders of Pregnancy.
기간: Enrollment to 6 week post partum visit
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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
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Provider and Patient Satisfaction by surveying participants on their experience with remote blood pressure monitoring.
기간: Enrollment to 6 week post partum visit
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Both participants and participant's primary OB provider will be surveyed on their satisfaction with RBPM. |
Enrollment to 6 week post partum visit
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
Data will be made available upon approval and publication of any manuscripts.
IPD 공유 액세스 기준
Users would need to request permission and a project proposal to access the data.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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