Diabetes Mellitus Type II,EHDINCT01566981
E-health Care Process Support for Diabetes Type II Patients
A study testing Computerised support to the Diabetes type II patients in people with Diabetes Mellitus Type II,, run by University of Primorska at 2 sites in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type II,
- What is being tested?
- Computerised support to the Diabetes type II patients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSlovenia
- Study dates
- Mar 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- significant co-morbidity
- Type 1 diabetes
- Insulin-dependent type 2 diabetes
Trial locations and contacts
2 sites in 1 country.
Slovenia2 sites
Department of family medicine in Ljubljana
Ljubljana, 1000
Department of Family medicine, Medical Faculty
Ljubljana, 1000
About this study
Official title: E-support for Healthcare Processes - DIABETES
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.
Read the 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).
- Conditions
- Diabetes Mellitus Type II,
- Being tested
- Computerised support to the Diabetes type II patients
- Keywords
- Diabetes mellitus tip II, eHealth solution, Health Information Technology, quality of life, family medicine, satisfaction with e-health care, primary care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerised support to the Diabetes type II patientsProcedure or surgery
Also called eDiabetes in Primary healthcare
The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes with ICT support (E-diabetes) | Experimental | 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 Receives: Procedure: Computerised support to the Diabetes type II patients |
| Diabetes without support | No intervention | The group of randomly selected patients with DM type II, without software application and web-based support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in HbA1C at 1 Year.
Measured: 1 year
Secondary outcomes (7)
Body Mass Index at 1 Year
Measured: one 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.
Measured: one year
Change of Blood Lipid Level ( Low Density Cholesterol)
Measured: baseline and one year
Quality of Patients' Life Via WONCA-COOP Questionnaire.
Measured: baseline and one year
Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire.
Measured: baseline and one year
Change of Blood Lipid Level ( Low Density Cholesterol)
Measured: baseline and six months
Change of the Following Parameter : HbA1C
Measured: baseline and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus Type II,Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia
- Responsible party
- Sponsor
- Investigators
- Andrej Brodnik, PhD, Principal investigator, University of Ljubljana, FRI and University of Primorska, DIST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566981
- Sponsor's protocol ID
- EHDI
- Acronym
- EHDI
- Status last verified
- Oct 2014
- First submitted
- 12 Feb 2012
- Last updated
- 29 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-support for Healthcare Processes - DIABETES
- ClinicalTrials.gov ID
- NCT01566981
- Acronym / sponsor ID
- EHDI / EHDI
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Posted 29 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes with ICT support (E-diabetes) | Experimental | Procedure: Computerised support to the Diabetes type II patientsThe 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 |
| Diabetes without support | No intervention | –The group of randomly selected patients with DM type II, without software application and web-based support. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- significant co-morbidity
- Type 1 diabetes
- Insulin-dependent type 2 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerised support to the Diabetes type II patientsAlso: eDiabetes in Primary healthcareThe randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process. | Procedure or surgery | Diabetes with ICT support (E-diabetes) |
Primary outcome
Change From Baseline in HbA1C at 1 Year.
Time frame: 1 year
7 secondary outcomes
Body Mass Index at 1 Year
Time frame: one year
Patients' Functional Health Status Via WONCA-COOP Questionnaire.
Time frame: one year
Change of Blood Lipid Level ( Low Density Cholesterol)
Time frame: baseline and one year
Quality of Patients' Life Via WONCA-COOP Questionnaire.
Time frame: baseline and one year
Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire.
Time frame: baseline and one year
Change of Blood Lipid Level ( Low Density Cholesterol)
Time frame: baseline and six months
Change of the Following Parameter : HbA1C
Time frame: baseline and six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrej Brodnik, PhD principal investigator
University of Ljubljana, FRI and University of Primorska, DIST
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerised support to the Diabetes type II patients in people with Diabetes Mellitus Type II,, run by University of Primorska at 2 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in HbA1C at 1 Year. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2014.