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

• ClinicalTrials.gov Identifier: NCT00606255
• Recruitment Status: Unknown
• First Posted: February 1, 2008
• Last Update Posted: February 1, 2008
• Sponsor: The Catholic University of Korea
• 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

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

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