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| Name | Class |
|---|---|
| University of Ljubljana School of Medicine, Slovenia | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes with ICT support (E-diabetes) | Experimental | 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 |
|
| Diabetes without support | No Intervention | The group of randomly selected patients with DM type II, without software application and web-based support. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerised support to the Diabetes type II patients | Procedure | The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1C at 1 Year. | 1 year |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrej Brodnik, PhD | University of Ljubljana, FRI and University of Primorska, DIST | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of family medicine in Ljubljana | Ljubljana | 1000 | Slovenia | |||
| Department of Family medicine, Medical Faculty |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process. 5 patients were lost to follow up, consequently 53 patients were included in final analysis |
| FG001 | Diabetes Without Support | 62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support. 8 patients were lost to follow up, so 54 patients were included in final analysis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetes With ICT Support (E-diabetes) | The group of randomly selected patients with Diabetes mellitus (DM) type II, who will get the software application and web- based support Intervention: Computerized support to the Diabetes type II patients Computerized 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in HbA1C at 1 Year. | Posted | Mean | Standard Deviation | percentage of glycated haemoglobin | 1 year |
|
15 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process. 5 patients were lost to follow up and 13 patients missed final consultation, consequently 53 patients were included in final analysis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rade Iljaž | Department of family medicine, Medical Faculty in Ljubljana | '386 31 300- 381 | radeiljaz@gmail.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011320 | Primary Health Care |
| ID | Term |
|---|---|
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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|
| 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 |
| Ljubljana |
| 1000 |
| Slovenia |
| BG001 | Diabetes Without Support | The group of randomly selected patients with DM type II, without software application and web-based support. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Years of DM treatment | Mean | Standard Deviation | years |
|
|
|
|
| Secondary | Body Mass Index at 1 Year | Posted | Mean | Standard Deviation | Kg/m2 | one year |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | one year |
|
|
|
| Secondary | Change of Blood Lipid Level ( Low Density Cholesterol) | Not Posted | baseline and one year |
| Secondary | Quality of Patients' Life Via WONCA-COOP Questionnaire. | Not Posted | baseline and one year |
| Secondary | Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire. | Not Posted | Nov 2013 | baseline and one year |
| Secondary | Change of Blood Lipid Level ( Low Density Cholesterol) | Not Posted | baseline and six months |
| Secondary | Change of the Following Parameter : HbA1C | Not Posted | baseline and six months |
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | Diabetes Without Support | 62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support. 8 patients were lost to follow up and 12 patients missed final consultation. 54 patients were included in final analysis. | 0 | 62 | 0 | 62 |
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| D004700 | Endocrine System Diseases |