Compliance of Antihypertensive Treatment Study (CAT Study)
Recruitment status was Active, not recruiting
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Compliance of Antihypertensive Treatment Study|
- 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 ]
|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)|
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
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606255
|Principal Investigator:||Sang Hong Baek, MD, PhD||KangNam St.Mary's Hospital The Catholic University of Korea|