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Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care

2026年8月10日 更新者：Wake Forest University Health Sciences

Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care: A Pragmatic Randomized Controlled Trial

The goal of this study is to identify what cuff delivery and BP log return modality most effectively achieve successful delivery of a self-measured blood pressure (SMBP) intervention in routine care, among adult primary care patients with uncontrolled hypertension?

調査の概要

状態

募集

条件

介入・治療

詳細な説明

The study team developed a clinical integration package as a multicomponent primary care-based approach to increase SMBP adoption through structured workflows, patient training, blood pressure logs, reminders/support, and clinical follow-up. Pilot work demonstrated that SMBP uptake can be significantly improved in underserved primary care settings. However, the pilot relied on research funds to purchase cuffs, which is not sustainable for health-system scale. A scalable model must identify practical pathways for patients to obtain standard validated blood pressure cuffs through routine care mechanisms, including vendor-supported, insurance-billed, consignment, or mail-order pathways, without depending on research-purchased devices.

In addition to cuff access, effective SMBP implementation also requires feasible approaches to patient training. Many patients do not receive standardized instruction on how to correctly measure and record home blood pressure readings, and intensive in-person training models may be difficult to sustain in routine primary care workflows. Health systems therefore need practical training strategies that balance effectiveness with scalability, ranging from brief hands-on education delivered during clinic visits to lower-touch written or self-guided educational materials.

Patients will be randomized to one of four arms:

  1. Mail-order cuff delivery with enhanced return conversation
  2. Mail-order cuff delivery with written instructions
  3. In-clinic cuff distribution with enhanced return conversation
  4. In-clinic cuff distribution with written instructions

All other intervention components will be standardized across study arms, including receipt of a blood pressure log, written instructions on when and how to obtain home blood pressure readings, and routine clinic processes for documenting or reviewing SMBP readings returned by patients. The design is intended to evaluate implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself. This design is intended to evaluate operational implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself.

研究の種類

介入

入学 (推定)

150

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Illinois
      • Chicago、Illinois、アメリカ、60617
        • 募集
        • Advocate Medical Group Chicago (Southeast)
        • コンタクト：
      • Chicago、Illinois、アメリカ、60619
        • 募集
        • Advocate Medical Group Chicago (Imani Village)
        • コンタクト：
      • Chicago、Illinois、アメリカ、60643
        • 募集
        • Advocate Medical Group Beverly
        • コンタクト：
      • Merrionette Park、Illinois、アメリカ、60803
        • 募集
        • Advocate Medical Group Merrionette Park
        • コンタクト：
      • Oak Lawn、Illinois、アメリカ、60453
        • 募集
        • Advocate Medical Group Oak Lawn (IM)
        • コンタクト：
      • Oak Lawn、Illinois、アメリカ、60453
        • 募集
        • Advocate Medical Group Oak Lawn (FP)
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Age 18 years or older.
  • Diagnosed hypertension documented prior to the index clinic visit.
  • Scheduled for and attends an in-person visit with a participating clinician at a study clinic.
  • Elevated BP (blood pressure) documented in Epic during rooming or the clinic visit before study enrollment, defined as systolic BP >=140 mmHg or diastolic BP >=90 mmHg.

Exclusion Criteria:

  • Visit is canceled, rescheduled, or the patient does not attend the visit.
  • Patient already has a usable home BP cuff provide through insurance within the past 5 years.
  • Patient declines assistance obtaining a BP cuff.
  • Patient declines submitting cuff order to insurance.
  • Patient unable to participate for operational reasons.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：ランダム化
  • 介入モデル：並列代入
  • 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
アクティブコンパレータ：Mail-order cuff delivery - Enhanced Return Conversation
Patients will receive a blood pressure cuff in the mail and have a conversation with the medical assistant on when and how to return their blood pressure log with the care team.
行動：Mail Order Cuff Delivery - Enhanced Return Conversation
Complete vendor form; provide blood pressure log/instructions; discuss with patient how and when to return bp log; submit vendor form for mail delivery; complete envelope checklist.
アクティブコンパレータ：Mail-order cuff delivery - Written instructions
Patients will receive a blood pressure cuff in the mail and receive written training on who and when to return their blood pressure log with the care team.
行動：Mail Order Cuff Delivery - Written Instructions
Complete vendor form; provide blood pressure log/instructions; submit vendor form for mail delivery; complete envelope checklist.
アクティブコンパレータ：In-clinic cuff distribution - Enhanced Return Conversation
Patients will receive a blood pressure cuff in the clinic and have a conversation with the medical assistant on when and how to return their blood pressure log with the care team.
行動：In-Clinic Cuff Delivery - Enhanced Return Conversation
Complete vendor form; provide blood pressure log/instructions; discuss with patient how and when to return bp log; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.
アクティブコンパレータ：In-clinic cuff distribution - Written instructions
Patients will receive a blood pressure cuff in the mail and receive written training on who and when to return their blood pressure log with the care team.
行動：In-Clinic Cuff Delivery - Written Instructions
Complete vendor form; provide blood pressure log/instructions; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.

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
Rate of Blood Pressure Receipt
時間枠：up to day 14
Number of participants that have received their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available
up to day 14
Rate of Cuff Order Completion
時間枠：up to day 14
Number of participants that have ordered their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available.
up to day 14
Rate of Return Modality Completion
時間枠：up to day 14
Number of participants that completed the assigned return modality as documented on the envelope checklist.
up to day 14

二次結果の測定

結果測定
メジャーの説明
時間枠
Time to Complete Intervention
時間枠：up to day 14
Number of days from index clinic visit to documentation of both cuff receipt and completion of assigned training modality.
up to day 14
Number of Participants Documenting at Least One Blood Pressure Reading
時間枠：up to day 21
Number of participants with at least one self-monitored blood pressure reading documented in the EHR within 21 days of cuff receipt.
up to day 21
Time Between Cuff Receipt and First Documented Reading
時間枠：up to day 21
Number of days between cuff receipt and first documented self-monitored blood pressure reading.
up to day 21
Rate of Workflow Barriers
時間枠：up to day 14
Number of participants with documented workflow barriers contributing to incomplete or non-concordant intervention delivery, including shipment issues, incomplete vendor forms, patient decline after workflow initiation, return modality not completed, missing documentation, clinic cuff inventory depletion, supply limitations, or other workflow disruptions identified through routine workflow documentation or operational follow-up activities.
up to day 14
Rate of Fidelity
時間枠：up to day 14
Number of participants that received the assigned cuff delivery modality and assigned return modality without crossover, reassignment, or missing assigned workflow components.
up to day 14
Rate of Differential Implementation Success
時間枠：up to day 14
Number of participants with successful delivery of both blood pressure cuff and return modality.
up to day 14

その他の成果指標

結果測定
メジャーの説明
時間枠
Change in Systolic Blood Pressure
時間枠：up to day 90
Change in systolic blood pressure using routinely documented clinic blood pressure values in Epic.
up to day 90
Rate of Medication Intensification
時間枠：up to day 90
Number of participants with addition of a new antihypertensive medication class, dose increase, or regimen intensification consistent with clinician-directed care using Epic medication order data.
up to day 90

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Wake Forest University Health Sciences

捜査官

  • 主任研究者：Rasha Khatib, PhD、Advocate Health

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月30日

一次修了 (推定)

2026年10月20日

研究の完了 (推定)

2026年11月20日

試験登録日

最初に提出

2026年7月2日

QC基準を満たした最初の提出物

2026年7月2日

最初の投稿 (実際)

2026年7月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月12日

QC基準を満たした最後の更新が送信されました

2026年8月10日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • IRB00151173

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?

いいえ

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

いいえ

米国FDA規制機器製品の研究

いいえ

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