Compliance of Antihypertensive Treatment Study (CAT Study)

NCT ID: NCT00606255

Last Updated: 2008-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1062 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-01-31

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

Conditions

Hypertension

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

A

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

No interventions assigned to this group

B

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

No interventions assigned to this group

C

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

KangNam St.Mary's Hospital The Catholic University of Korea

Principal Investigators

Sang Hong Baek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

KangNam St.Mary's Hospital The Catholic University of Korea

Other Identifiers

CVAL489AKR19T

Identifier Type: -

Identifier Source: org_study_id