Management of Patients With Type 2 Diabetes and Hypertension Using Mobile Health Care System
| Tracking Information | |||||
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| First Received Date ICMJE | June 20, 2007 | ||||
| Last Updated Date | May 19, 2008 | ||||
| Start Date ICMJE | July 2007 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
HbA1c, fasting blood glucose level, Weight change, Blood pressure level in the morning, lipid profiles [ Time Frame: baseline, 3months later ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00489879 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
exercise time during one week, self reported change in dietary habit, fat consumption ratio [ Time Frame: baseline, 3months later ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Management of Patients With Type 2 Diabetes and Hypertension Using Mobile Health Care System | ||||
| Official Title ICMJE | Efficacy of Mobile Health Care System in Patients With Type 2 Diabets and Hypertension | ||||
| Brief Summary | The purpose of this study is to determine whether cellular phone based health care system is effective in the treatment of diabetes and hypertension. |
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| Detailed Description | Diabetes care is facilitated by a patient's being engaged in a self-management program with the advice and counsel of physicians, but many diabetic patients can not receive the continous monitoing and advice from his physician in their every day life. It is very difficult to keep up life style modification in their real life. Few studies have examined the effects of cellular phone based intervention that provide an interactive component daily. Our goal is to test the hypothesis that diabetes and hypertension management using cellular phone based health care system would result in significant improvement of blood glucose and blood pressure level. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Mobile Health Care System (DrUB) | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Kwon HS, Cho JH, Kim HS, Song BR, Ko SH, Lee JM, Kim SR, Chang SA, Kim HS, Cha BY, Lee KW, Son HY, Lee JH, Lee WC, Yoon KH. Establishment of blood glucose monitoring system using the internet. Diabetes Care. 2004 Feb;27(2):478-83. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 140 | ||||
| Completion Date | October 2007 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00489879 | ||||
| Other Study ID Numbers ICMJE | Seoul R&BD Program | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Kyung Mook Choi, Korea University | ||||
| Study Sponsor ICMJE | Korea University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Korea University | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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