E-health Care Process Support for Diabetes Type II Patients (EHDI)
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|ClinicalTrials.gov Identifier: NCT01566981|
Recruitment Status : Completed
First Posted : March 30, 2012
Results First Posted : October 29, 2014
Last Update Posted : October 29, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Type II,||Procedure: Computerised support to the Diabetes type II patients||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||E-support for Healthcare Processes - DIABETES|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: Diabetes with ICT support (E-diabetes)
The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients
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
No Intervention: Diabetes without support
The group of randomly selected patients with DM type II, without software application and web-based support.
- Change From Baseline in HbA1C at 1 Year. [ Time Frame: 1 year ]
- Body Mass Index at 1 Year [ Time Frame: one year ]
- Patients' Functional Health Status Via WONCA-COOP Questionnaire. [ Time Frame: one year ]WONCA COOP questionnaire measure seven core aspects of functional status, therefore this instrument consists of 7 five-point ordinal sub-scales. Each scale ranging from 1 ('no limitation at all') to 5 ('severely limited'); for 'change in health' score 1 means 'much better' and score 5'much worse'. Sub-scales are averaged to compute a total score.
- Change of Blood Lipid Level ( Low Density Cholesterol) [ Time Frame: baseline and one year ]
- Quality of Patients' Life Via WONCA-COOP Questionnaire. [ Time Frame: baseline and one year ]
- Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire. [ Time Frame: baseline and one year ]
- Change of Blood Lipid Level ( Low Density Cholesterol) [ Time Frame: baseline and six months ]
- Change of the Following Parameter : HbA1C [ Time Frame: baseline and six months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566981
|Department of family medicine in Ljubljana|
|Ljubljana, Slovenia, 1000|
|Department of Family medicine, Medical Faculty|
|Ljubljana, Slovenia, 1000|
|Principal Investigator:||Andrej Brodnik, PhD||University of Ljubljana, FRI and University of Primorska, DIST|