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Compliance of Antihypertensive Treatment Study (CAT Study) (CAT)

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ClinicalTrials.gov Identifier: NCT00606255
Recruitment Status : Unknown
Verified January 2008 by The Catholic University of Korea.
Recruitment status was:  Active, not recruiting
First Posted : February 1, 2008
Last Update Posted : February 1, 2008
Sponsor:
Information provided by:
The Catholic University of Korea

Tracking Information
First Submitted Date January 28, 2008
First Posted Date February 1, 2008
Last Update Posted Date February 1, 2008
Study Start Date January 2008
Estimated Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 31, 2008)
the percentage of missed doses, delayed doses, the percentage of correct dosing period and blood pressure [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Compliance of Antihypertensive Treatment Study (CAT Study)
Official Title Compliance of Antihypertensive Treatment Study
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)

Condition Hypertension
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 31, 2008)
1062
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2009
Estimated Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00606255
Other Study ID Numbers CVAL489AKR19T
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sang Hong Baek MD,PhD/ Professor of Medicine, KangNam St.Mary's Hospital The Catholic University of Korea
Study Sponsor The Catholic University of Korea
Collaborators Not Provided
Investigators
Principal Investigator: Sang Hong Baek, MD, PhD KangNam St.Mary's Hospital The Catholic University of Korea
PRS Account The Catholic University of Korea
Verification Date January 2008