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

Primary Purpose

Diabetes Mellitus Type II,

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Computerised support to the Diabetes type II patients
Sponsored by
University of Primorska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus Type II, focused on measuring Diabetes mellitus tip II, eHealth solution, Health Information Technology, quality of life, family medicine, satisfaction with e-health care, primary care

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of family medicine in Ljubljana
  • Department of Family medicine, Medical Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diabetes with ICT support (E-diabetes)

Diabetes without support

Arm 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

The group of randomly selected patients with DM type II, without software application and web-based support.

Outcomes

Primary Outcome Measures

Change From Baseline in HbA1C at 1 Year.

Secondary Outcome Measures

Body Mass Index at 1 Year
Patients' Functional Health Status Via WONCA-COOP Questionnaire.
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)
Quality of Patients' Life Via WONCA-COOP Questionnaire.
Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire.
Change of Blood Lipid Level ( Low Density Cholesterol)
Change of the Following Parameter : HbA1C

Full Information

First Posted
February 12, 2012
Last Updated
October 28, 2014
Sponsor
University of Primorska
Collaborators
University of Ljubljana School of Medicine, Slovenia
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1. Study Identification

Unique Protocol Identification Number
NCT01566981
Brief Title
E-health Care Process Support for Diabetes Type II Patients
Acronym
EHDI
Official Title
E-support for Healthcare Processes - DIABETES
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Primorska
Collaborators
University of Ljubljana School of Medicine, Slovenia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type II,
Keywords
Diabetes mellitus tip II, eHealth solution, Health Information Technology, quality of life, family medicine, satisfaction with e-health care, primary care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetes with ICT support (E-diabetes)
Arm Type
Experimental
Arm 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
Arm Title
Diabetes without support
Arm Type
No Intervention
Arm Description
The group of randomly selected patients with DM type II, without software application and web-based support.
Intervention Type
Procedure
Intervention Name(s)
Computerised support to the Diabetes type II patients
Other Intervention Name(s)
eDiabetes in Primary healthcare
Intervention Description
The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process.
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1C at 1 Year.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Body Mass Index at 1 Year
Time Frame
one year
Title
Patients' Functional Health Status Via WONCA-COOP Questionnaire.
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
Title
Change of Blood Lipid Level ( Low Density Cholesterol)
Time Frame
baseline and one year
Title
Quality of Patients' Life Via WONCA-COOP Questionnaire.
Time Frame
baseline and one year
Title
Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire.
Time Frame
baseline and one year
Title
Change of Blood Lipid Level ( Low Density Cholesterol)
Time Frame
baseline and six months
Title
Change of the Following Parameter : HbA1C
Time Frame
baseline and six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrej Brodnik, PhD
Organizational Affiliation
University of Ljubljana, FRI and University of Primorska, DIST
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of family medicine in Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Department of Family medicine, Medical Faculty
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

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E-health Care Process Support for Diabetes Type II Patients

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