E-health Care Process Support for Diabetes Type II Patients (EHDI)
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ClinicalTrials.gov Identifier: NCT01566981 |
Recruitment Status
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Completed
First Posted
: March 30, 2012
Results First Posted
: October 29, 2014
Last Update Posted
: October 29, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | February 12, 2012 | |||
First Posted Date ICMJE | March 30, 2012 | |||
Results First Submitted Date | July 27, 2014 | |||
Results First Posted Date | October 29, 2014 | |||
Last Update Posted Date | October 29, 2014 | |||
Study Start Date ICMJE | March 2012 | |||
Actual Primary Completion Date | February 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change From Baseline in HbA1C at 1 Year. [ Time Frame: 1 year ] | |||
Original Primary Outcome Measures ICMJE |
Successful maintenance or improvement of non insulin diabetes condition through change of the following parameter : HbA1C, [ Time Frame: baseline and 1 year ] | |||
Change History | Complete list of historical versions of study NCT01566981 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | E-health Care Process Support for Diabetes Type II Patients | |||
Official Title ICMJE | E-support for Healthcare Processes - DIABETES | |||
Brief Summary | The purpose of the study is to clinically evaluate a new approach to treatment of patients with diabetes mellitus type II by using specially developed mobile-internet software solution. The effect of information and communication technologies (ICT) to improve the integrated care of people with diabetes will be identified, developed, introduced and clinically evaluated. The investigators expect that usage of an e-Health application in health care of patients with diabetes mellitus type II could improve the following healthcare outcomes: results of the laboratory tests (with emphasis on HbA1C value), regular medication usage, blood pressure values, Body mass index (BMI) values, diet, regular exercise and quality of life. |
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Detailed Description | Diabetes mellitus (DM) is defined as a "group of common metabolic disorders that share the phenotype of hyperglycemia". It is generally agreed that in Caucasian populations the prevalence rate is between 2% and 6%. Prevalence rate of DM in SLovenia is about 5%. Type 2 DM accounts for 90% to 95% of all diabetes cases. Results of many clinical studies demonstrated the great potential of information and communication technology (ICT) applications to improve health care of patients with chronic diseases including diabetes mellitus. In this study an ICT mobile environment to improve the process of an integrated care of people with Diabetes mellitus will be identified, developed, introduced and clinically evaluated. The study will include 140 patients diagnosed with diabetes mellitus type II who are managed in primary care. The study will use and evaluation questionnaire that will cover issues regarding the patient quality of life. Subjects with a blood pressure meter and a scale, will be able to enter the value of the systolic and diastolic blood pressure and the body weight. Subjects will be motivated to regularly enter data about their blood pressure, body weight, dietary misconducts and to complete available questioners. In addition to this, users can enter values about their physical activity (type, duration, intensity). |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Diabetes Mellitus Type II, | |||
Intervention ICMJE | Procedure: Computerised support to the Diabetes type II patients
The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process.
Other Name: eDiabetes in Primary healthcare |
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Study Arms |
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Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment ICMJE |
120 | |||
Original Estimated Enrollment ICMJE |
140 | |||
Actual Study Completion Date | February 2014 | |||
Actual Primary Completion Date | February 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Slovenia | |||
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Administrative Information | ||||
NCT Number ICMJE | NCT01566981 | |||
Other Study ID Numbers ICMJE | EHDI | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University of Primorska | |||
Study Sponsor ICMJE | University of Primorska | |||
Collaborators ICMJE | University of Ljubljana School of Medicine, Slovenia | |||
Investigators ICMJE |
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PRS Account | University of Primorska | |||
Verification Date | October 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |