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Evaluating the effectiveness of an individualized monitoring and education system and related services for the optimal patient care of chronic diseases in primary clinics

Evaluating the effectiveness of an individualized monitoring and education system and related services for the optimal patient care of chronic diseases in primary clinics

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008396
Enrollment
1000
Registered
2023-04-28
Start date
2022-08-03
Completion date
Unknown
Last updated
2023-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Behavioral : ? Intervention period: 6 months ? Control group: No additional treatment other than conventional treatment ? In addition to conventional treatment, intervention group 1 and intervention

Sponsors

The Catholic University of Korea
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? 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

Exclusion criteria

Exclusion criteria: ? 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactJin-Hee Lee

The Catholic University of Korea

jheelee@catholic.ac.kr+82-2-2258-8286

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: May 16, 2026