E-health Care Process Support for Diabetes Type II Patients

Diabetes Mellitus Type II, Clinical Trial

— EHDI  

Official title:

E-support for Healthcare Processes - DIABETES

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566981
• Other study ID #: EHDI
• Status: Completed
• Phase: N/A
• First received: February 12, 2012
• Last updated: October 28, 2014
• Start date: March 2012
• Est. completion date: February 2014

Study information

• Verified date: October 2014
• Source: University of Primorska
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type II,
• Diabetes Mellitus, Type 2

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Slovenia	Department of family medicine in Ljubljana	Ljubljana
Slovenia	Department of Family medicine, Medical Faculty	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University of Primorska	University of Ljubljana School of Medicine, Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1C at 1 Year.		1 year	No
Secondary	Body Mass Index at 1 Year		one year	No
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.	one year	No
Secondary	Change of Blood Lipid Level ( Low Density Cholesterol)		baseline and one year	No
Secondary	Quality of Patients' Life Via WONCA-COOP Questionnaire.		baseline and one year	No
Secondary	Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire.		baseline and one year	No
Secondary	Change of Blood Lipid Level ( Low Density Cholesterol)		baseline and six months	No
Secondary	Change of the Following Parameter : HbA1C		baseline and six months	No