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

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ClinicalTrials.gov Identifier: NCT01566981
Recruitment Status : Completed
First Posted : March 30, 2012
Results First Posted : October 29, 2014
Last Update Posted : October 29, 2014
Sponsor:
Collaborator:
University of Ljubljana School of Medicine, Slovenia
Information provided by (Responsible Party):
University of Primorska

Tracking Information
First Submitted Date  ICMJE February 12, 2012
First Posted Date  ICMJE March 30, 2012
Results First Submitted Date  ICMJE July 27, 2014
Results First Posted Date  ICMJE 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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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