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

Publication ,  Journal Article
Jackson, GL; Weinberger, M; Kirshner, MA; Stechuchak, KM; Melnyk, SD; Bosworth, HB; Coffman, CJ; Neelon, B; Van Houtven, C; Gentry, PW; May, CL ...
Published in: Contemp Clin Trials
September 2016

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.

Duke Scholars

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

September 2016

Volume

50

Start / End Page

5 / 15

Location

United States

Related Subject Headings

  • Young Adult
  • United States Department of Veterans Affairs
  • United States
  • Sex Factors
  • Research Design
  • Public Health
  • Patient Care Team
  • Middle Aged
  • Medication Therapy Management
  • Male
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Jackson, G. L., Weinberger, M., Kirshner, M. A., Stechuchak, K. M., Melnyk, S. D., Bosworth, H. B., … Edelman, D. (2016). Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics. Contemp Clin Trials, 50, 5–15. https://doi.org/10.1016/j.cct.2016.07.009
Jackson, George L., Morris Weinberger, Miriam A. Kirshner, Karen M. Stechuchak, Stephanie D. Melnyk, Hayden B. Bosworth, Cynthia J. Coffman, et al. “Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.Contemp Clin Trials 50 (September 2016): 5–15. https://doi.org/10.1016/j.cct.2016.07.009.
Jackson GL, Weinberger M, Kirshner MA, Stechuchak KM, Melnyk SD, Bosworth HB, et al. Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics. Contemp Clin Trials. 2016 Sep;50:5–15.
Jackson, George L., et al. “Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.Contemp Clin Trials, vol. 50, Sept. 2016, pp. 5–15. Pubmed, doi:10.1016/j.cct.2016.07.009.
Jackson GL, Weinberger M, Kirshner MA, Stechuchak KM, Melnyk SD, Bosworth HB, Coffman CJ, Neelon B, Van Houtven C, Gentry PW, Morris IJ, Rose CM, Taylor JP, May CL, Han B, Wainwright C, Alkon A, Powell L, Edelman D. Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics. Contemp Clin Trials. 2016 Sep;50:5–15.
Journal cover image

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

September 2016

Volume

50

Start / End Page

5 / 15

Location

United States

Related Subject Headings

  • Young Adult
  • United States Department of Veterans Affairs
  • United States
  • Sex Factors
  • Research Design
  • Public Health
  • Patient Care Team
  • Middle Aged
  • Medication Therapy Management
  • Male