Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition

Abstract Background Reach Out is a factorial trial studying multicomponent behavioral interventions to reduce blood pressure in hypertensive emergency department patients. The original study protocol was published in June 2020. Here, we describe the updated protocol, including a supplemental study,...

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Autores principales:	Lesli E. Skolarus, Mackenzie Dinh, Kelley M. Kidwell, Zahera Farhan, Candace Whitfield, Deborah A. Levine, William J. Meurer
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Hypertension Emergency Medicine Multiphase Optimization Strategy Cognition Health Equity Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/0244ea5ee8aa4b169e091ae12c4b6a91
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spelling	oai:doaj.org-article:0244ea5ee8aa4b169e091ae12c4b6a912021-11-28T12:28:38ZSupplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition10.1186/s13063-021-05806-41745-6215https://doaj.org/article/0244ea5ee8aa4b169e091ae12c4b6a912021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05806-4https://doaj.org/toc/1745-6215Abstract Background Reach Out is a factorial trial studying multicomponent behavioral interventions to reduce blood pressure in hypertensive emergency department patients. The original study protocol was published in June 2020. Here, we describe the updated protocol, including a supplemental study, Reach Out Cognition. Reach Out Cognition is a remote study that will assess the acceptability, feasibility, and satisfaction of digital, self-administered cognitive assessments and Bluetooth-enabled, self-measured blood pressure monitoring in the Reach Out population. We will also estimate the prevalence of mild cognitive impairment in Reach Out participants. Methods Reach Out Cognition includes remote enrollment and follow-up assessments. Reach Out Cognition extends Reach Out data collection past the current 12 months to 15 and 18 months. Participants will be Reach Out participants who complete their 12-month outcome assessments and opt to continue in the cohort study. Participants will continue to receive the Reach Out intervention, consisting of (1) daily healthy behavior text messaging and (2) weekly self-measured blood pressure monitoring. Blood pressure will be measured using Bluetooth-enabled self-measured blood pressure monitoring devices, and cognition will be measured using digital self-administered cognitive assessments at 12, 15, and 18 months. Discussion Reach Out Cognition will explore the potential of remote, digital, self-administered assessments of blood pressure and cognition among predominantly working-age Black Americans. Reach Out Cognition will inform future clinical trials and clinical remote monitoring of blood pressure and cognition that may lead to new approaches to treating and reducing hypertension and cognitive disparities. Trial registration ClinicalTrials.gov NCT03422718. The record was first available to the public on January 30, 2018, prior to the enrollment of patients on March 25, 2019.Lesli E. SkolarusMackenzie DinhKelley M. KidwellZahera FarhanCandace WhitfieldDeborah A. LevineWilliam J. MeurerBMCarticleHypertensionEmergency MedicineMultiphase Optimization StrategyCognitionHealth EquityMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Hypertension Emergency Medicine Multiphase Optimization Strategy Cognition Health Equity Medicine (General) R5-920
spellingShingle	Hypertension Emergency Medicine Multiphase Optimization Strategy Cognition Health Equity Medicine (General) R5-920 Lesli E. Skolarus Mackenzie Dinh Kelley M. Kidwell Zahera Farhan Candace Whitfield Deborah A. Levine William J. Meurer Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition
description	Abstract Background Reach Out is a factorial trial studying multicomponent behavioral interventions to reduce blood pressure in hypertensive emergency department patients. The original study protocol was published in June 2020. Here, we describe the updated protocol, including a supplemental study, Reach Out Cognition. Reach Out Cognition is a remote study that will assess the acceptability, feasibility, and satisfaction of digital, self-administered cognitive assessments and Bluetooth-enabled, self-measured blood pressure monitoring in the Reach Out population. We will also estimate the prevalence of mild cognitive impairment in Reach Out participants. Methods Reach Out Cognition includes remote enrollment and follow-up assessments. Reach Out Cognition extends Reach Out data collection past the current 12 months to 15 and 18 months. Participants will be Reach Out participants who complete their 12-month outcome assessments and opt to continue in the cohort study. Participants will continue to receive the Reach Out intervention, consisting of (1) daily healthy behavior text messaging and (2) weekly self-measured blood pressure monitoring. Blood pressure will be measured using Bluetooth-enabled self-measured blood pressure monitoring devices, and cognition will be measured using digital self-administered cognitive assessments at 12, 15, and 18 months. Discussion Reach Out Cognition will explore the potential of remote, digital, self-administered assessments of blood pressure and cognition among predominantly working-age Black Americans. Reach Out Cognition will inform future clinical trials and clinical remote monitoring of blood pressure and cognition that may lead to new approaches to treating and reducing hypertension and cognitive disparities. Trial registration ClinicalTrials.gov NCT03422718. The record was first available to the public on January 30, 2018, prior to the enrollment of patients on March 25, 2019.
format	article
author	Lesli E. Skolarus Mackenzie Dinh Kelley M. Kidwell Zahera Farhan Candace Whitfield Deborah A. Levine William J. Meurer
author_facet	Lesli E. Skolarus Mackenzie Dinh Kelley M. Kidwell Zahera Farhan Candace Whitfield Deborah A. Levine William J. Meurer
author_sort	Lesli E. Skolarus
title	Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition
title_short	Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition
title_full	Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition
title_fullStr	Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition
title_full_unstemmed	Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition
title_sort	supplement study update for reach out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: reach out cognition
publisher	BMC
publishDate	2021
url	https://doaj.org/article/0244ea5ee8aa4b169e091ae12c4b6a91
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Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition

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