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

Tracking Information
First Submitted Date ICMJE	February 12, 2012
First Posted Date ICMJE	March 30, 2012
Results First Submitted Date	July 27, 2014
Results First Posted Date	October 29, 2014
Last Update Posted Date	October 29, 2014
Study Start Date ICMJE	March 2012
Actual Primary Completion Date	February 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 28, 2014)	Change From Baseline in HbA1C at 1 Year. [ Time Frame: 1 year ]
Original Primary Outcome Measures ICMJE; (submitted: March 27, 2012)	Successful maintenance or improvement of non insulin diabetes condition through change of the following parameter : HbA1C, [ Time Frame: baseline and 1 year ]
Change History	Complete list of historical versions of study NCT01566981 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 28, 2014)	Body Mass Index at 1 Year [ Time Frame: one year ]; Patients' Functional Health Status Via WONCA-COOP Questionnaire. [ Time Frame: one year ]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 ]; Quality of Patients' Life Via WONCA-COOP Questionnaire. [ Time Frame: baseline and one year ]; Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire. [ Time Frame: baseline and one year ]; Change of Blood Lipid Level ( Low Density Cholesterol) [ Time Frame: baseline and six months ]; Change of the Following Parameter : HbA1C [ Time Frame: baseline and six months ]
Original Secondary Outcome Measures ICMJE; (submitted: March 27, 2012)	Successful maintenance or improvement of the following measured parameter: Body mass index. [ Time Frame: baseline and one year ]; Change of patients' quality of patients via WONCA-COOP questionnaire. [ Time Frame: baseline and six months ]; Change of blood lipid level ( low density holesterol) [ Time Frame: baseline and one year ]; Quality of Patients' Life Via WONCA-COOP Questionnaire. [ Time Frame: baseline and one year ]; Change of patients' quality of patients via WONCA-COOP questionnaire. [ Time Frame: baseline and one year ]; Change of blood lipid level ( low density holesterol) [ Time Frame: baseline and six months ]; Change of the Following Parameter : HbA1C [ Time Frame: baseline and six months ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	E-health Care Process Support for Diabetes Type II Patients
Official Title ICMJE	E-support for Healthcare Processes - DIABETES
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).
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
Condition ICMJE	Diabetes Mellitus Type II,
Intervention ICMJE	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
Study Arms	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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 28, 2014)	120
Original Estimated Enrollment ICMJE; (submitted: March 27, 2012)	140
Actual Study Completion Date	February 2014
Actual Primary Completion Date	February 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Slovenia
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01566981
Other Study ID Numbers ICMJE	EHDI
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University of Primorska
Study Sponsor ICMJE	University of Primorska
Collaborators ICMJE	University of Ljubljana School of Medicine, Slovenia
Investigators ICMJE	Principal Investigator: Andrej Brodnik, PhD University of Ljubljana, FRI and University of Primorska, DIST
PRS Account	University of Primorska
Verification Date	October 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP