Clinical trial NCT01566981: E-health Care Process Support for Diabetes Type II Patients
Official title: E-support for Healthcare Processes - DIABETES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type II,
Keywords: Diabetes mellitus tip II
eHealth solution
Health Information Technology
quality of life
family medicine
satisfaction with e-health care
primary care
Lead sponsor: University of Primorska
Sponsor class: OTHER
Collaborators: name: University of Ljubljana School of Medicine, Slovenia
First posted: 2012-03-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Change From Baseline in HbA1C at 1 Year.
timeFrame: 1 year
Secondary outcomes:
measure: Body Mass Index at 1 Year
timeFrame: one year
measure: Patients' Functional Health Status Via WONCA-COOP Questionnaire.
timeFrame: one year
measure: Change of Blood Lipid Level ( Low Density Cholesterol)
timeFrame: baseline and one year
measure: Quality of Patients' Life Via WONCA-COOP Questionnaire.
timeFrame: baseline and one year
measure: Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire.
timeFrame: baseline and one year
measure: Change of Blood Lipid Level ( Low Density Cholesterol)
timeFrame: baseline and six months
measure: Change of the Following Parameter : HbA1C
timeFrame: baseline and six months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Department of family medicine in Ljubljana
city: Ljubljana
country: Slovenia
facility: Department of Family medicine, Medical Faculty
Study officials:
affiliation: University of Ljubljana, FRI and University of Primorska, DIST
name: Andrej Brodnik, PhD
role: PRINCIPAL_INVESTIGATOR
References: