Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Results First Received: July 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Diabetes Mellitus Type II,
Intervention: Procedure: Computerised support to the Diabetes type II patients

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.

5 patients were lost to follow up, consequently 53 patients were included in final analysis

Diabetes Without Support

62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.

8 patients were lost to follow up, so 54 patients were included in final analysis.


Participant Flow:   Overall Study
    Diabetes With ICT Support (E-diabetes)     Diabetes Without Support  
STARTED     58     62  
COMPLETED     53     54  
NOT COMPLETED     5     8  
Lost to Follow-up                 5                 8  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Diabetes With ICT Support (E-diabetes)

The group of randomly selected patients with Diabetes mellitus (DM) type II, who will get the software application and web- based support Intervention: Computerized support to the Diabetes type II patients

Computerized 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.

Diabetes Without Support The group of randomly selected patients with DM type II, without software application and web-based support.
Total Total of all reporting groups

Baseline Measures
    Diabetes With ICT Support (E-diabetes)     Diabetes Without Support     Total  
Number of Participants  
[units: participants]
  58     62     120  
Age  
[units: years]
Mean ± Standard Deviation
  56.3  ± 10.5     54.7  ± 11.1     55.5  ± 10.7  
Gender  
[units: participants]
     
Female     22     25     47  
Male     36     37     73  
Years of DM treatment  
[units: years]
Mean ± Standard Deviation
  5.1  ± 5.7     5.7  ± 4.8     5.5  ± 5.3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in HbA1C at 1 Year.   [ Time Frame: 1 year ]

2.  Secondary:   Body Mass Index at 1 Year   [ Time Frame: one year ]

3.  Secondary:   Patients' Functional Health Status Via WONCA-COOP Questionnaire.   [ Time Frame: one year ]

4.  Secondary:   Change of Blood Lipid Level ( Low Density Cholesterol)   [ Time Frame: baseline and one year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Quality of Patients' Life Via WONCA-COOP Questionnaire.   [ Time Frame: baseline and one year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire.   [ Time Frame: baseline and one year ]
Results not yet reported.   Anticipated Reporting Date:   11/2013   Safety Issue:   No

7.  Secondary:   Change of Blood Lipid Level ( Low Density Cholesterol)   [ Time Frame: baseline and six months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Change of the Following Parameter : HbA1C   [ Time Frame: baseline and six months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Rade Iljaž
Organization: Department of family medicine, Medical Faculty in Ljubljana
phone: '386 31 300- 381
e-mail: radeiljaz@gmail.com


No publications provided


Responsible Party: University of Primorska
ClinicalTrials.gov Identifier: NCT01566981     History of Changes
Other Study ID Numbers: EHDI
Study First Received: February 12, 2012
Results First Received: July 27, 2014
Last Updated: October 28, 2014
Health Authority: Slovenia: Ethics Committee