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Titrated Disease Management for Patients With Hypertension | Clinical Trials | Clareo Health

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Titrated Disease Management for Patients With Hypertension

Randomized Trial of Titrated Disease Management for Patients With Hypertension

NCT01390272•VA Office of Research and Development

Summary

This randomized clinical trial examines whether programs aimed at matching resources to patient hypertension (i.e. high blood pressure) control lead to greater reduction in systolic blood pressure (top number of blood pressure reading) than simply having maintenance phone calls in addition to usual care. Answering this question will provide important evidence concerning the overall goal of sustained long-term implementation of the disease management programs as part of patient aligned care teams in the Veterans Affairs and other healthcare systems.

Detailed Description

Project Objectives: The investigators are conducting a two-arm 18-month randomized clinical trial for patients with pharmaceutically treated hypertension for which systolic BP is not controlled (\>/=140 mmHg for non-diabetic or \>/=130 mmHg for diabetic patients). The primary aim will be to compare two treatment arms/strategies in terms of impact on systolic BP control: Arm 1 - An intervention arm using titrated disease management in which patients' hypertension control, assessed at baseline, 6 and 12 months, will be used to decide the resource intensity of strategies: 1) Medium/level 1 resource intensity strategy: a registered nurse will provide monthly tailored behavioral support telephone calls + home BP monitoring; 2) High/level 2 resource intensity strategy: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management; and 3) Booster (low) resource intensity strategy: a license practice nurse (LPN) will provide bi-monthly, non-tailored behavioral support telephone calls to patients whose systolic BP comes under control. Arm 2 - A control arm, in which an LPN will provide bi-monthly non-tailored behavioral support telephone calls (same procedures as the booster (low) resource intensity strategy component of the titrated intervention).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age \>= 18 years.
•Assigned primary care provider in one of the clinics of the Durham VA Medical Center (VAMC) (including Community Based Outpatient Clinics for example - Hillandale Clinic and Greenville (CBOC)).
•Had at least 1 primary care visit at the Durham VA or affiliated CBOC in the last year.
•Diagnosis of hypertension requiring medication, as determined by: ICD 401.0, 401.1, or 401.9 for \>= 2 outpatient encounters during the prior year and Received a prescription for at least 1 of the following classes of hypertensive medication in the previous year: 1) ACE inhibitors; 2) alpha blockers; 3) angiogenesis II inhibitors; 4) beta blockers; 5) calcium channel blockers; 6) diuretics; 7) antihypertensive combination; and/or 8) antihypertensives, other.
•Out of control systolic blood pressure: Durham VAMC (including CBOCs or other affiliated clinics captured in the Durham VAMC electronic health record) outpatient BP measurements \>= 150 mmHg for non-diabetic or \>= 140 mmHg for diabetic patients over the last year and last systolic BP measurement \>= 140 mmHg for non-diabetic or \>= 130 mmHg for diabetic patients. If additional patients need to be approached to be offered the opportunity for further screening, non-diabetic patients with mean outpatient systolic BP of \>= 140 mmHg or diabetic patients with mean outpatient systolic BP of \>= 130 mmHg over the past year may be approached.
•Patients must indicate that they both:
•Have a VA or affiliated clinic provider that they consider to be their main PCP.
•Receive the majority of healthcare at the Durham VA Medical Center (or affiliated clinic - such as Hillandale or Greenville).

Exclusion Criteria

•Active diagnosis of psychosis.
•Diagnosis of metastatic cancer.
•Type 1 diabetes
•Class IV congestive heart failure (CHF).
•Currently receiving kidney dialysis or if estimated glomerular filtration rate (eGFR) levels are \<= 15.
•Chronic obstructive pulmonary disease (COPD) requiring oxygen.
•Resident in nursing home or receiving home healthcare.
•Patient is pregnant or reports planning to become pregnant in the next two years
•At the time of potential enrollment, participating in another ongoing hypertension, diabetes, cholesterol, or cardiovascular disease clinical trial.
•Planning to leave the area prior to the anticipated end of participation.
+10 more criteria

Locations (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Key Dates

Start Date

July 27, 2012

Primary Completion Date

October 31, 2016

Completion Date

October 31, 2016

Last Updated

February 11, 2019

Enrollment

385

ACTUAL participants

Conditions

Hypertension

Interventions

Booster/ low resource

BEHAVIORAL

Booster/ low resource

BEHAVIORAL

Medium/Level 1 resource intensity

BEHAVIORAL

High/Level 2 resource intensity

BEHAVIORAL

Natural History of Noncirrhotic Portal Hypertension

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265

Hypertension (HTN)Hyperhomocysteinemia+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Titrated Disease Management for Patients With Hypertension

Inclusion Criteria

Exclusion Criteria

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