Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.
Contemp Clin Trials
; 50: 5-15, 2016 09.
Article
in En
| MEDLINE
| ID: mdl-27417982
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.
Key words
Full text:
1
Database:
MEDLINE
Main subject:
Research Design
/
Disease Management
/
Hypertension
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Antihypertensive Agents
Type of study:
Clinical_trials
/
Guideline
Limits:
Adolescent
/
Adult
/
Aged
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Female
/
Humans
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Male
/
Middle aged
Country/Region as subject:
America do norte
Language:
En
Year:
2016
Type:
Article