E-health Care Process Support for Diabetes Type II Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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E-support for Healthcare Processes - DIABETES

Conditions
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Diabetes Mellitus Type II,

Intervention / Treatment
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* Procedure: Computerised support to the Diabetes type II patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes, treated with non-pharmacological interventions or/and tablets (Non-Insulin-Dependent Diabetes Mellitus) Internet connection and personal computer /lap-top computer Mobile phone Sufficient level of Internet and e-mail usage - checked by short questionnaire Age >18 or <75 years Exclusion Criteria: significant co-morbidity Type 1 diabetes Insulin-dependent type 2 diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes with ICT support (E-diabetes)<br>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<br>* The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process.<br>* Other names: eDiabetes in Primary healthcare;|
| No Intervention: Diabetes without support<br>The group of randomly selected patients with DM type II, without software application and web-based support. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1C at 1 Year. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index at 1 Year |  | one year | 
| Patients' Functional Health Status Via WONCA-COOP Questionnaire. | 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. | one year | 
| Change of Blood Lipid Level ( Low Density Cholesterol) |  | baseline and one year | 
| Quality of Patients' Life Via WONCA-COOP Questionnaire. |  | baseline and one year | 
| Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire. |  | baseline and one year | 
| Change of Blood Lipid Level ( Low Density Cholesterol) |  | baseline and six months | 
| Change of the Following Parameter : HbA1C |  | baseline and six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus tip II, eHealth solution, Health Information Technology, quality of life, family medicine, satisfaction with e-health care, primary care