Compliance of Antihypertensive Treatment Study (CAT Study)

• Conditions: Hypertension

• Registration Number: NCT00606255
• Lead Sponsor: The Catholic University of Korea

Brief Summary

Study Rational:

In general, chronic disease without symptoms such as hypertension, the treatment compliance is relative low and is difficult to increase. The low compliance is related to poor prognosis. There are many factors that effect to compliance of antihypertensive drug. Education is one factor that can be controlled by doctors. Therefore, in this study, the compliance of the patients in 3 groups of active training group, passive training group, and no training group (usual treatment group) will be compared to evaluate the effect of training for controlling of hypertension.

Detailed Description

Objectives:

Primary objective - The compliance of each group for the antihypertensive drug is evaluated and compared.

The patients are allocated to three groups; active training group, passive training group, no training group (usual treatment group) and training is performed as described below.

* Active training group: Electronic Pill-Boxes with SMS service 1/week, training material provided

* Passive training group: Electronic Pill-Boxes ,Training material provided

* Usual treatment group: Electronic Pill-Boxes, maintain current treatment method

Secondary objective -

* Evaluate other factor that has effect on the compliance of antihypertensive drug.

* Evaluate the blood pressure lowering effect according to the compliance of antihypertensive drug.

* Evaluate the percentage of missed doses, the percentage of delayed doses, the percentage of multiple doses.

* Evaluate the effect of education on the compliance of antihypertensive drug.

Timelines FPFV : Jan, 2008 LPLV: Dec. 2008

Methodology:

This clinical trial is multi center, prospective, randomized, open, observational study.

This study is to compare the compliance for antihypertensive drugs according to different method of patient training and the observation period per patient is 6 month. There is no fixed visit date and the visits are made according to patient's periodic treatment schedules.

To come up with representative and reliable nation wide statistical data, from hospitals nation wide patient who receive drugs (ACE-I, ARB, β-Blocker, CCB, Diuretic) for blood pressure lowering purpose according to the prescription patterns of investigator will be registered.

Number of centers \& patients:

No. of centers: 20 general hospitals No. of patients: 1,062 patients

Study Timeline

• Status Verified: 2008-01
• Study Start: 2008-01
• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-01-31
• Last Update Submitted: 2008-01-31
• Study First Posted: 2008-02-01
• Last Update Posted: 2008-02-01
• Primary Completion: 2008-12
• Study Completion: 2009-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1062

Inclusion Criteria

• Patient diagnosed as hypertension.
• Hypertension patients diagnosed and treated but not meeting the target blood pressure. (Target blood pressure: SBP<140mmHg and DBP<90mmHg. In case having concomitant disease JNC-VII guideline is followed)
• Patients age over 18

Exclusion Criteria

• Patients with severe chronic disease
• Patients scheduled for operation within 6 month period.
• Patients currently participating in other clinical study.
• Pregnant, nursing patient and patient with potential to be pregnant.
• Patient who can not or has no intension to participate in compliance check.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the percentage of missed doses, delayed doses, the percentage of correct dosing period and blood pressure	6 months