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NCT00495794 · ClinicalTrials.gov registry record · NA

Adherence and Intensification of Medications (AIM) Implementation Study

A NA study of Hypertension and Diabetes, sponsored by US Department of Veterans Affairs.

Completed
Registry status
NA
Development phase
4,622
Enrollment target
1
Study location

NCT00495794 is a NA study of Hypertension and Diabetes that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 4,622 participants, above the 3,498-participant average among 470 other Hypertension trials with a reported enrollment target (32% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00495794, a NA study of Hypertension and Diabetes, has completed, sponsored by US Department of Veterans Affairs.

COMPLETED
Registry status
NA
Development phase
4,622 participants
Enrollment target
1
Study location

Study Summary

Background: Good blood pressure (BP) control among patients with diabetes is essential in preventing diabetes complications and has been found to be not only cost-effective but cost-saving. Nonetheless, over 25% of VA patients with diabetes do not have adequate BP control. Among these poorly controlled patients, over 65% have problems with medication adherence or inadequate intensification of medications. We therefore propose a partnership with the VA Pharmacy Benefits Management (PBM) Office and VISN 11 to evaluate a tailored clinical pharmacist-based intervention to improve medication management, adherence and BP control. Objectives: The specific objectives of this implementation study are: 1) To evaluate the effects of the intervention on blood pressure (primary outcome) and glycemic and lipid control (secondary outcomes); 2) To assess the impact of the intervention on patients' adherence to blood pressure, anti-hyperglycemic, and lipid-lowering regimens, and intensity of these regimens; 3) To evaluate the cost-effectiveness of the intervention compared to usual care; 4) To evaluate the level of attainment of intervention implementation, examine the process of intervention implementation, and determine the potential for sustainability.

Conditions Studied

Interventions

  • BEHAVIORAL Clinical pharmacist-based intervention

Study Locations (1)

Michigan

  • VA Ann Arbor Healthcare System, Ann Arbor, MI - Ann Arbor

Trial Details

FieldValue
Enrollment Target 4,622 participants
Start Date 2008-08
Est. Completion 2012-07
Phase NA

Sponsor

US Department of Veterans Affairs

632 total trials

What the Registry Record Tells You About NCT00495794

The ClinicalTrials.gov registry entry for NCT00495794 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 4,622 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 3,498-participant average among 470 other Hypertension trials with a reported enrollment target (32% higher). The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Clinical pharmacist-based intervention is the first listed.

NCT00495794 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.

Frequently Asked Questions

What is clinical trial NCT00495794 about?

NCT00495794 is a clinical study titled "Adherence and Intensification of Medications (AIM) Implementation Study". Background: Good blood pressure (BP) control among patients with diabetes is essential in preventing diabetes complications and has been found to be not only cost-effective but cost-saving. Nonetheless, over 25% of VA patients with diabetes do not have adequate BP control. Among these poorly control...

What is the current status of trial NCT00495794?

This trial is currently completed. It is a NA study. The enrollment target is 4,622 participants. The study started on 2008-08. Estimated completion is 2012-07.

What conditions does trial NCT00495794 study?

This clinical trial studies the following conditions: Hypertension, Diabetes.

What interventions are being tested in trial NCT00495794?

The interventions under investigation include: Clinical pharmacist-based intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT00495794?

This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00495794 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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