E-health Care Process Support for Diabetes Type II Patients (EHDI)
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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 |
- 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 ]
- 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: | September 2013 |
| Estimated 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 |
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| Contact: Rade Iljaž, MD | +386 31 300 381 | Rade Iljaz <radeiljaz@gmail.com> |
| Contact: Tatjana Zrimec, Phd | +386 41 461 610 | tatjana.zrimec@upr.si |
| Slovenia | |
| Department of family medicine in Ljubljana | Recruiting |
| Ljubljana, Slovenia, 1000 | |
| Contact: Rade Iljaž, MD 38631300381 radeiljaz@gmail.com | |
| Contact: Davorina Petek, MD, PhD davorina.petek@gmail.com | |
| Sub-Investigator: Andrej Kravos, MD, Master | |
| 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: | March 12, 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 May 22, 2013