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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sophia Connelly, BA
- 電話番号：605-312-3332
- メール：Sophia.Connelly@sanfordhealth.org
研究連絡先のバックアップ
- 名前：Andrew Williams, PhD, MD
- 電話番号：701-777-6718
- メール：Andrew.D.Williams@und.edu
研究場所
-
-
North Dakota
-
Fargo、North Dakota、アメリカ、58104
- Sanford Health
-
コンタクト：
- Sophia Connelly, BA
- 電話番号：605-312-3332
- メール：Sophia.Connelly@sanfordhealth.org
-
コンタクト：
- Peter VanEerden, MD
- 電話番号：(701) 234-3443
- メール：Peter.VanEerden@sanfordhealth.org
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主任研究者：
- Peter VanEerden, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Remote Blood Pressure Monitoring Adherence using the Homedics 700 Series Arm Blood Pressure Monitor or Equivalent for Women with Hypertensive Disorders of Pregnancy.
時間枠：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.
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
Data will be made available upon approval and publication of any manuscripts.
IPD 共有アクセス基準
Users would need to request permission and a project proposal to access the data.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。