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

This study is ongoing, but not recruiting participants.
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 31, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Diabetes Mellitus Type II,
Procedure: Computerised support to the Diabetes type II patients

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: E-support for Healthcare Processes - DIABETES

Resource links provided by NLM:


Further study details as provided by University of Primorska:

Primary Outcome Measures:
  • Successful maintenance or improvement of non insulin diabetes condition through change of the following parameter : HbA1C, [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Successful maintenance or improvement of the following measured parameter: Body mass index. [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
  • Change of patients' quality of patients via WONCA-COOP questionnaire. [ Time Frame: baseline and six months ] [ Designated as safety issue: No ]
  • Change of blood lipid level ( low density holesterol) [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
  • Quality of patients' life via WONCA-COOP questionnaire. [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
  • Change of patients' quality of patients via WONCA-COOP questionnaire. [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
  • Change of blood lipid level ( low density holesterol) [ Time Frame: baseline and six months ] [ Designated as safety issue: No ]
  • change of the following parameter : HbA1C [ Time Frame: baseline and six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
No Intervention: Diabetes without support
The group of randomly selected patients with DM type II, without software application and web-based support.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566981

Locations
Slovenia
Department of family medicine in Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University of Primorska
University of Ljubljana School of Medicine, Slovenia
Investigators
Principal Investigator: Davorina Petek, MD, PhD. Department of familly medicine, Medical faculty, University of Ljubljana
  More Information

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
Last Updated: October 31, 2013
Health Authority: Slovenia: Ethics Committee

Keywords provided by University of Primorska:
Diabetes mellitus tip II
eHealth solution
Health Information Technology
quality of life
family medicine
satisfaction with e-health care
primary care

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 22, 2014