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Completed Not applicable Interventional Results available

Trial of Low and High Intensity Strategies to Maintain BP Control

ClinicalTrials.gov ID: NCT00760552

Public ClinicalTrials.gov record NCT00760552. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Trial of Low And High Intensity Strategies to Maintain Blood Pressure Control

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The long-range goal of this research is to advance understanding of long-term blood pressure (BP) control in patients with uncontrolled hypertension (HTN). The work builds on our experience in implementing new models of care in Veterans Affairs (VA) and non-VA settings, including three National Institute of Health (NIH) studies of pharmacist-based HTN management. The long-term effectiveness of such models, especially in veterans, is unknown. Thus, the primary goal of this study is to evaluate how to sustain long-term BP control in veterans with HTN following a 6-month intensive pharmacist intervention. This study will enroll veterans with uncontrolled HTN into a 6-month intensive pharmacist-based intervention. Following this initial intervention, participants will be randomized to continued intervention or a one-time patient and provider education intervention. BP will be compared in the two groups over a 2-year follow-up period. The intervention to control and sustain BP will follow VA guidelines and include: 1) comprehensive medication assessment by the pharmacist; 2) an explicit plan to intensify treatment if indicated; 3) strategies to improve adherence; and 4) follow-up pharmacist visits to sustain BP control. The intervention is based on models identified in a recent Agency for Healthcare Research and Quality (AHRQ) report as being the most potent strategies to improve BP. The study will benefit from a strong research team with expertise in guideline development, implementation science, quality measurement, and behavioral science. The study will also provide important information on the degree to which BP control deteriorates after patients are referred back to usual care. The specific aims and related hypotheses of the study are to: Aim 1:Compare BP control in patients randomized to long-term continuation of the pharmacist intervention or to a less intense one-time patient and provider education intervention. Hypothesis 1a: Patients randomized to the continued pharmacist intervention will have higher rates of BP control 24 months after randomization. Hypothesis 1b: Patients randomized to the continued pharmacist intervention will have lower mean BP 24 months after randomization. Aim 2: Compare antihypertensive medication intensification in patients randomized to the continued pharmacist intervention or the less intense intervention. Hypothesis 2: A higher proportion of patients who continued the pharmacist intervention will have medication intensification over the 24-month follow-up. Aim 3: Compare medication adherence in the two intervention groups. Hypothesis 3a: Medication adherence will be higher in patients randomized to the continued pharmacist intervention group during the 24 month follow-up period. Hypothesis 3b: Improvements in medication adherence will be associated with improvements in BP during each study interval.

Study identification

NCT ID
NCT00760552
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
249 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2009
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013
Last update posted
Apr 26, 2015

2009 – 2013

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Iowa City VA Health Care System, Iowa City, IA Iowa City Iowa 52246-2208

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00760552, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 26, 2015 · Synced Sep 3, 2026

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