Compliance of Antihypertensive Treatment Study (CAT Study)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by The Catholic University of Korea.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT00606255
First received: January 28, 2008
Last updated: January 31, 2008
Last verified: January 2008
  Purpose

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.


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Compliance of Antihypertensive Treatment Study

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • the percentage of missed doses, delayed doses, the percentage of correct dosing period and blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1062
Study Start Date: January 2008
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Active training group: Electronic Pill-Boxes with SMS service 1/week, training material provided
B
Passive training group: Electronic Pill-Boxes ,Training material provided
C
Usual treatment group: Electronic Pill-Boxes, maintain current treatment method

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606255

Sponsors and Collaborators
The Catholic University of Korea
Investigators
Principal Investigator: Sang Hong Baek, MD, PhD KangNam St.Mary's Hospital The Catholic University of Korea
  More Information

No publications provided

Responsible Party: Sang Hong Baek MD,PhD/ Professor of Medicine, KangNam St.Mary's Hospital The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT00606255     History of Changes
Other Study ID Numbers: CVAL489AKR19T
Study First Received: January 28, 2008
Last Updated: January 31, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by The Catholic University of Korea:
blood pressure
compliance
treatment

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014