E-support for Healthcare Processes - DIABETES
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus Type II,
- Sponsor
- University of Primorska
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Change From Baseline in HbA1C at 1 Year.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change From Baseline in HbA1C at 1 Year.
Time Frame: 1 year
Secondary Outcomes
- Body Mass Index at 1 Year(one year)
- Patients' Functional Health Status Via WONCA-COOP Questionnaire.(one year)
- Change of Blood Lipid Level ( Low Density Cholesterol)(baseline and six months)
- 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 the Following Parameter : HbA1C(baseline and six months)