E-health Care Process Support for Diabetes Type II Patients

NCT ID: NCT01566981

Last Updated: 2014-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-02-28

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).

Conditions

Diabetes Mellitus Type II,

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Computerised support to the Diabetes type II patients

Intervention Type: PROCEDURE

The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process.

Diabetes without support

The group of randomly selected patients with DM type II, without software application and web-based support.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

eDiabetes in Primary healthcare

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ljubljana School of Medicine, Slovenia

OTHER

Sponsor Role: collaborator

University of Primorska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrej Brodnik, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ljubljana, FRI and University of Primorska, DIST

Locations

Department of family medicine in Ljubljana

Ljubljana, , Slovenia

Department of Family medicine, Medical Faculty

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

EHDI

Identifier Type: -

Identifier Source: org_study_id