Clinical trial NCT00606255: Compliance of Antihypertensive Treatment Study (CAT Study)
Official title: Compliance of Antihypertensive Treatment Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Keywords: blood pressure
compliance
treatment
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2008-02-01
Enrollment: 1062
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ① Patient diagnosed as hypertension.

② 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)

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

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.

Primary outcomes:
measure: the percentage of missed doses, delayed doses, the percentage of correct dosing period and blood pressure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: KangNam St.Mary's Hospital The Catholic University of Korea
name: Sang Hong Baek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: