Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.
dc.contributor.author | Jackson, George L | |
dc.contributor.author | Weinberger, Morris | |
dc.contributor.author | Kirshner, Miriam A | |
dc.contributor.author | Stechuchak, Karen M | |
dc.contributor.author | Melnyk, Stephanie D | |
dc.contributor.author | Bosworth, Hayden B | |
dc.contributor.author | Coffman, Cynthia J | |
dc.contributor.author | Neelon, Brian | |
dc.contributor.author | Van Houtven, Courtney | |
dc.contributor.author | Gentry, Pamela W | |
dc.contributor.author | Morris, Isis J | |
dc.contributor.author | Rose, Cynthia M | |
dc.contributor.author | Taylor, Jennifer P | |
dc.contributor.author | May, Carrie L | |
dc.contributor.author | Han, Byungjoo | |
dc.contributor.author | Wainwright, Christi | |
dc.contributor.author | Alkon, Aviel | |
dc.contributor.author | Powell, Lesa | |
dc.contributor.author | Edelman, David | |
dc.date.accessioned | 2024-01-31T00:59:07Z | |
dc.date.available | 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 | |
dc.identifier.issn | 1551-7144 | |
dc.identifier.issn | 1559-2030 | |
dc.identifier.uri | ||
dc.language | eng | |
dc.publisher | Elsevier BV | |
dc.relation.ispartof | Contemporary clinical trials | |
dc.relation.isversionof | 10.1016/j.cct.2016.07.009 | |
dc.rights.uri | ||
dc.subject | Humans | |
dc.subject | Hypertension | |
dc.subject | Antihypertensive Agents | |
dc.subject | Blood Pressure Monitoring, Ambulatory | |
dc.subject | Exercise | |
dc.subject | Health Behavior | |
dc.subject | Behavior Therapy | |
dc.subject | Age Factors | |
dc.subject | Sex Factors | |
dc.subject | Research Design | |
dc.subject | United States Department of Veterans Affairs | |
dc.subject | Adolescent | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Middle Aged | |
dc.subject | Disease Management | |
dc.subject | Patient Care Team | |
dc.subject | United States | |
dc.subject | Female | |
dc.subject | Male | |
dc.subject | Medication Therapy Management | |
dc.subject | Young Adult | |
dc.subject | 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 | |
duke.contributor.orcid | Coffman, Cynthia J|0000-0002-4554-1463 | |
duke.contributor.orcid | Van Houtven, Courtney|0000-0002-0783-1611 | |
duke.contributor.orcid | Edelman, David|0000-0001-7112-6151 | |
pubs.begin-page | 5 | |
pubs.end-page | 15 | |
pubs.organisational-group | Duke | |
pubs.organisational-group | School of Medicine | |
pubs.organisational-group | Basic Science Departments | |
pubs.organisational-group | Clinical Science Departments | |
pubs.organisational-group | Institutes and Centers | |
pubs.organisational-group | Biostatistics & Bioinformatics | |
pubs.organisational-group | Family Medicine and Community Health | |
pubs.organisational-group | Medicine | |
pubs.organisational-group | Psychiatry & Behavioral Sciences | |
pubs.organisational-group | Medicine, General Internal Medicine | |
pubs.organisational-group | Duke Cancer Institute | |
pubs.organisational-group | Duke Clinical Research Institute | |
pubs.organisational-group | Institutes and Provost's Academic Units | |
pubs.organisational-group | Center for the Study of Aging and Human Development | |
pubs.organisational-group | Initiatives | |
pubs.organisational-group | Duke Science & Society | |
pubs.organisational-group | Population Health Sciences | |
pubs.organisational-group | Duke Innovation & Entrepreneurship | |
pubs.organisational-group | Psychiatry & Behavioral Sciences, Behavioral Medicine & Neurosciences | |
pubs.organisational-group | Duke - Margolis Center For Health Policy | |
pubs.organisational-group | Biostatistics & Bioinformatics, Division of Biostatistics | |
pubs.publication-status | Published | |
pubs.volume | 50 |
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