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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Diabetes Mellitus Type II,
Intervention Procedure: Computerised support to the Diabetes type II patients
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diabetes With ICT Support (E-diabetes) Diabetes Without Support
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 58 62
Completed 53 54
Not Completed 5 8
Reason Not Completed
Lost to Follow-up             5             8
Arm/Group Title Diabetes With ICT Support (E-diabetes) Diabetes Without Support Total
Hide Arm/Group Description

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.

The group of randomly selected patients with DM type II, without software application and web-based support. Total of all reporting groups
Overall Number of Baseline Participants 58 62 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 62 participants 120 participants
56.3  (10.5) 54.7  (11.1) 55.5  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 62 participants 120 participants
Female
22
  37.9%
25
  40.3%
47
  39.2%
Male
36
  62.1%
37
  59.7%
73
  60.8%
Years of DM treatment  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 62 participants 120 participants
5.1  (5.7) 5.7  (4.8) 5.5  (5.3)
1.Primary Outcome
Title Change From Baseline in HbA1C at 1 Year.
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diabetes With ICT Support (E-diabetes) Diabetes Without Support
Hide Arm/Group Description:

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

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 and 54 patients were included in final analysis.

Overall Number of Participants Analyzed 53 54
Mean (Standard Deviation)
Unit of Measure: percentage of glycated haemoglobin
0.6925  (1.4708) 0.1707  (1.0617)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diabetes With ICT Support (E-diabetes)
Comments

Null hypothesis was that Information and Communication Technology (ICT) supported diabetes care could have significant impact on reduction of baseline glycated hemoglobin (EHbA1c) after 1 year follow-up.

The sample in intervention group was normally distributed, so observed power (two-tailed hypothesis) was 0.45, for Cohen's d= 0.6 and alpha level =0.05

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments without adjustments, df=39
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.6925
Confidence Interval (2-Sided) 95%
0.2221 to 1.1629
Parameter Dispersion
Type: Standard Deviation
Value: 1.4708
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Body Mass Index at 1 Year
Hide Description [Not Specified]
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diabetes Without Support Diabetes With ICT Support (E-diabetes)
Hide Arm/Group Description:
The group of randomly selected patients with DM type II, without software application and web-based support.

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.

Overall Number of Participants Analyzed 54 53
Mean (Standard Deviation)
Unit of Measure: Kg/m2
31.76  (4.87) 32.6  (5.14)
3.Secondary Outcome
Title Patients' Functional Health Status Via WONCA-COOP Questionnaire.
Hide Description 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.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diabetes With ICT Support (E-diabetes) Diabetes Without Support
Hide Arm/Group Description:

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

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 and 54 patients were included in final analysis.

Overall Number of Participants Analyzed 53 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.12  (0.66) 1.89  (0.58)
4.Secondary Outcome
Title Change of Blood Lipid Level ( Low Density Cholesterol)
Hide Description [Not Specified]
Time Frame baseline and one year
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Quality of Patients' Life Via WONCA-COOP Questionnaire.
Hide Description [Not Specified]
Time Frame baseline and one year
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire.
Hide Description [Not Specified]
Time Frame baseline and one year
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Change of Blood Lipid Level ( Low Density Cholesterol)
Hide Description [Not Specified]
Time Frame baseline and six months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Change of the Following Parameter : HbA1C
Hide Description [Not Specified]
Time Frame baseline and six months
Outcome Measure Data Not Reported
Time Frame 15 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diabetes With ICT Support (E-diabetes) Diabetes Without Support
Hide Arm/Group Description

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 and 13 patients missed final consultation, consequently 53 patients were included in final analysis

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 and 12 patients missed final consultation. 54 patients were included in final analysis.

All-Cause Mortality
Diabetes With ICT Support (E-diabetes) Diabetes Without Support
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Diabetes With ICT Support (E-diabetes) Diabetes Without Support
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/62 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diabetes With ICT Support (E-diabetes) Diabetes Without Support
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/62 (0.00%) 
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
Responsible Party: University of Primorska
ClinicalTrials.gov Identifier: NCT01566981     History of Changes
Other Study ID Numbers: EHDI
First Submitted: February 12, 2012
First Posted: March 30, 2012
Results First Submitted: July 27, 2014
Results First Posted: October 29, 2014
Last Update Posted: October 29, 2014