Randomized trial protocol for remote monitoring for equity in advancing the control of hypertension in safety net systems (REACH-SNS) study.
Contemp Clin Trials
; 126: 107112, 2023 03.
Article
em En
| MEDLINE
| ID: mdl-36738916
ABSTRACT
BACKGROUND:
Self-measured blood pressure monitoring (SMBP) is essential to effective management of hypertension. This study aims to evaluate effectiveness and implementation of SMBP that leverages cellular-enabled home BP monitors without a need for Wi-Fi or Bluetooth; simple communication modalities such as text messaging to support patient engagement; and integration into existing team-based workflows in safety-net clinics.METHODS:
This study will be conducted with patients in San Francisco who are treated within a network of safety-net clinics. English and Spanish-speaking patients with diagnosed hypertension will be eligible for the trial if they have recent BP readings ≥140/90 mmHg and do not have co-morbid conditions that make home BP monitoring more complex to manage. This study will implement a three-arm randomized controlled trial to compare varying levels of implementation support 1) cellular-enabled BP monitors (with minimal implementation support), 2) cellular-enabled BP monitors with protocol-based implementation support (text reminders for patients; aggregated BP summaries sent to primary care providers), and 3) cellular-enabled BP monitors and pharmacist-led support (pharmacist coaching and independent medication adjustments).RESULTS:
For the main analysis, we will use mixed effects linear regression to compare the change in primary outcome of systolic BP. Secondary outcomes include BP control (<140/90 mmHg), medication intensification, patient-reported outcomes, and implementation processes (i.e., engagement with the intervention).DISCUSSION:
This study will design and test a digital health intervention for use in marginalized populations treated within safety net settings, evaluating both effectiveness and implementation to advance more equitable health outcomes.Palavras-chave
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Ano de publicação:
2023
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Article