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E-health Care Process Support for Diabetes Type II Patients (EHDI)

This study has been completed.
Sponsor:
Collaborator:
University of Ljubljana School of Medicine, Slovenia
Information provided by (Responsible Party):
University of Primorska
ClinicalTrials.gov Identifier:
NCT01566981
First received: February 12, 2012
Last updated: October 28, 2014
Last verified: October 2014
History of Changes

February 12, 2012
October 28, 2014
March 2012
February 2014   (final data collection date for primary outcome measure)
Change From Baseline in HbA1C at 1 Year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Successful maintenance or improvement of non insulin diabetes condition through change of the following parameter : HbA1C, [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01566981 on ClinicalTrials.gov Archive Site
  • Body Mass Index at 1 Year [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Patients' Functional Health Status Via WONCA-COOP Questionnaire. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.
  • Change of Blood Lipid Level ( Low Density Cholesterol) [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
  • Quality of Patients' Life Via WONCA-COOP Questionnaire. [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
  • Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire. [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
  • Change of Blood Lipid Level ( Low Density Cholesterol) [ Time Frame: baseline and six months ] [ Designated as safety issue: No ]
  • Change of the Following Parameter : HbA1C [ Time Frame: baseline and six months ] [ Designated as safety issue: No ]
  • Successful maintenance or improvement of the following measured parameter: Body mass index. [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
  • Change of patients' quality of patients via WONCA-COOP questionnaire. [ Time Frame: baseline and six months ] [ Designated as safety issue: No ]
  • Change of blood lipid level ( low density holesterol) [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
  • Quality of Patients' Life Via WONCA-COOP Questionnaire. [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
  • Change of patients' quality of patients via WONCA-COOP questionnaire. [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
  • Change of blood lipid level ( low density holesterol) [ Time Frame: baseline and six months ] [ Designated as safety issue: No ]
  • Change of the Following Parameter : HbA1C [ Time Frame: baseline and six months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
E-health Care Process Support for Diabetes Type II Patients
E-support for Healthcare Processes - DIABETES

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).
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Diabetes Mellitus Type II,
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.
Other Name: eDiabetes in Primary healthcare
  • Experimental: 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
    Intervention: Procedure: Computerised support to the Diabetes type II patients
  • No Intervention: Diabetes without support
    The group of randomly selected patients with DM type II, without software application and web-based support.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Slovenia
 
NCT01566981
EHDI
No
Not Provided
Not Provided
University of Primorska
University of Primorska
University of Ljubljana School of Medicine, Slovenia
Principal Investigator: Andrej Brodnik, PhD University of Ljubljana, FRI and University of Primorska, DIST
University of Primorska
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP