Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.

dc.contributor.author

Jackson, George L

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Weinberger, Morris

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Kirshner, Miriam A

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Stechuchak, Karen M

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Melnyk, Stephanie D

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Bosworth, Hayden B

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Coffman, Cynthia J

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Neelon, Brian

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Van Houtven, Courtney

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Gentry, Pamela W

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Morris, Isis J

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Rose, Cynthia M

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Taylor, Jennifer P

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May, Carrie L

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Han, Byungjoo

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Wainwright, Christi

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Alkon, Aviel

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Powell, Lesa

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Edelman, David

dc.date.accessioned

2024-01-31T00:59:07Z

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2024-01-31T00:59:07Z

dc.date.issued

2016-09

dc.description.abstract

Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy.

dc.identifier

S1551-7144(16)30116-1

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1551-7144

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1559-2030

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https://hdl.handle.net/10161/29915

dc.language

eng

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Elsevier BV

dc.relation.ispartof

Contemporary clinical trials

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10.1016/j.cct.2016.07.009

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https://creativecommons.org/licenses/by-nc/4.0

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Humans

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Hypertension

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Antihypertensive Agents

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Blood Pressure Monitoring, Ambulatory

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Exercise

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Health Behavior

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Behavior Therapy

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Age Factors

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Sex Factors

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Research Design

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United States Department of Veterans Affairs

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Adolescent

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Adult

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Aged

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Middle Aged

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Disease Management

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Patient Care Team

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United States

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Female

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Male

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Medication Therapy Management

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Young Adult

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Black or African American

dc.title

Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.

dc.type

Journal article

duke.contributor.orcid

Bosworth, Hayden B|0000-0001-6188-9825

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Coffman, Cynthia J|0000-0002-4554-1463

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Van Houtven, Courtney|0000-0002-0783-1611

duke.contributor.orcid

Edelman, David|0000-0001-7112-6151

pubs.begin-page

5

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15

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Duke

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School of Medicine

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Basic Science Departments

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Clinical Science Departments

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Institutes and Centers

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Biostatistics & Bioinformatics

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Family Medicine and Community Health

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Medicine

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Psychiatry & Behavioral Sciences

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Medicine, General Internal Medicine

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Duke Cancer Institute

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Duke Clinical Research Institute

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Institutes and Provost's Academic Units

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Center for the Study of Aging and Human Development

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Initiatives

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Duke Science & Society

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Population Health Sciences

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Duke Innovation & Entrepreneurship

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Psychiatry & Behavioral Sciences, Behavioral Medicine & Neurosciences

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Duke - Margolis Center For Health Policy

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Biostatistics & Bioinformatics, Division of Biostatistics

pubs.publication-status

Published

pubs.volume

50

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