Evaluating the effectiveness of an individualized monitoring and education system and related services for the optimal patient care of chronic diseases in primary clinics
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0008396
- Lead Sponsor
- The Catholic University of Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1000
? Diabetics patients
· Type 2 diabetes
· Over 19 years old and 75 years old
· HbA1c 6.7% or higher at baseline
· Those who have consented to participate in this clinical trial and have given their written consent
? Hypertensive patients
· Essential hypertension
· Over 19 years old and 75 years old
· Mean sitting systolic and diastolic blood pressure at baseline :
-Mean sitting systolic blood pressure (MSSBP): 130 mmHg or more and less than 180 mmHg
-Mean sitting diastolic blood pressure (MSDBP): less than 110 mmHg
· Those who have consented to participate in this clinical trial and have given their written consent
? Diabetics patients
· Receiving insulin pump treatment
· Severe renal disease: eGFR<30ml/min
· Heart function falls under New Your Heart Association III-IV
· Diagnosed with a malignant tumor within the past 5 years and have not completed treatment
· Taking systemic steroids or immunosuppressants that affect blood glucose control
· Pregnant or lactating
· Judged inappropriate to participate in the study due to general weakness, etc.
? Hypertensive patients
· Taking 3 or more antihypertensive medications at baseline
· History of secondary hypertension or suspected secondary hypertension
· Symptomatic orthostatic hypotension
· History of cerebral infarction
· History of myocardial infarction or unstable angina
· Undergone percutaneous coronary intervention (PCI) or coronary artery replacement surgery
· Severe heart disease: Heart failure (NYHA grade III ~ IV)
· Clinically significant arrhythmias
· Cardiomyopathy
· Severe kidney or liver disease
· Diagnosed with a malignant tumor within the past 5 years and have not completed treatment
· Pregnant or lactating
· Judged inappropriate to participate in the study due to general weakness, etc.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diabetes management: difference in HbA1c change at 6 months compared to baseline;Hypertension management: difference in SBP change at 6 months compared to the baseline
- Secondary Outcome Measures
Name Time Method Diabetes management: Difference in achievement of HbA1c <7%, difference in achievement of HbA1c <6.5%, difference in achievement of individualized HbA1c target, difference in achievement of blood pressure target, difference in achievement of blood lipid target, assessment of lifestyle change, evaluation of depression, quality of life change and medication adherence;Hypertension management: Difference in achievement of individualized blood pressure control target, difference in achievement of HbA1c target, difference in achievement of blood lipid target, the occurrence of new complications after registration, evaluation of lifestyle changes, evaluation of depression, quality of life change and medication adherence;Economic evaluation: Cost-of-illness(COI), decision tree model development, sensitivity analysis, financial impact assessment;Evaluation of usability and satisfaction with the new system and related services