Type 2 DiabetesNCT01009528
Electronic Feedback on Diabetic Care to General Practitioners
A study testing Electronic feedback system on diabetes care in people with Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this study is to determine whether electronic feedback to general practitioners on quality of Type 2-Diabetes care increases the quality of care measured on process and outcome measures contained in the national guidelines. Effect evaluation will be performed using a mixed method design. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Electronic feedback system on diabetes care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,458 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2007to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prevalent Type 2-diabetes as confirmed by Primary Care Physician.
- Patient alive throughout the intervention period.
- GP actively working throughout the intervention period (not retired).
Who cannot join
- death during intervention
- moved out of geographic area during intervention
- GP retired during intervention
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of General Medicine, Institute of Public Health, Aarhus University
Aarhus, 8000
About this study
Official title: Development and Evaluation of Electronic Feedback, a Tool for Quality Assurance of the Diabetic Care in General Practice
The aim of this study is to determine whether electronic feedback to general practitioners on quality of Type 2-Diabetes care increases the quality of care measured on process and outcome measures contained in the national guidelines. Effect evaluation will be performed using a mixed method design.
Read the detailed description
Background: In an effort to optimize diabetes care in general practice, an electronical feedback system has been developed. The system will be evaluated both quantitative and qualitative.
Method: The general practitioners (GP´s) of the Region of Southern Denmark have been randomised to either admission or no admission to the electronic feedback system. The system was launched 1/3-2007 and ran for one year prior to evaluation.
Quantitative evaluation by assessment of the following end-points: Patients Hba1c-level, number of patients who have had their hba1c-level measured within the last year, cholesterol-level and number of patients who have had an eye examination within the last year.
Qualitative evaluation by interviewing GP´s who have had admission to the system.
Qualitative data have been collected through interviews with intervention GPs, designed to uncover motivational factors as well as barriers concerning the use of feedback on chronic care in general practice. Data are being analyzed.
Quantitative data are being gathered. Perspective: This project will shed light on the value of electronic feedback systems within chronic care in general practice.
Based on this project it will be possible to set up a system for automatic electronic monitoring and feedback of the quality of care in general practice, taking motivational factors of the GP s into account during implementation.
- Conditions
- Type 2 Diabetes
- Being tested
- Electronic feedback system on diabetes care
- Keywords
- Quality of care, General Practice, Electronic Feedback System
- 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.
Electronic feedback system on diabetes careDevice
Also called Electronic feedback system, Decission support system
An electronic feedback system was introduced in randomized primary care clinics providing an overview of quality of care. The intervention ran for 15 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Admission to electronic feedback system Receives: Device: Electronic feedback system on diabetes care |
| control | No intervention | Control group. No special attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome and process measures from the danish diabetes guideline
Measured: 1/3 2007-1/6 2008
Secondary outcomes (1)
Interview data concerning the impact of the electronic feedback system in the intervention clinics
Measured: 1/3 2007-1/6 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startMar 2007
- Primary completionJun 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,458 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Torsten Lauritzen, MD, Dr. Med., Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009528
- Sponsor's protocol ID
- 2008-41-2792
- Status last verified
- Nov 2009
- First submitted
- 5 Nov 2009
- Last updated
- 9 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guldberg TL, Lauritzen T, Kristensen JK, Vedsted P. The effect of feedback to general practitioners on quality of care for people with type 2 diabetes. A systematic review of the literature. BMC Fam Pract. 2009 May 6;10:30. doi: 10.1186/1471-2296-10-30.
PubMed 19419548Guldberg TL, Vedsted P, Kristensen JK, Lauritzen T. Improved quality of Type 2 diabetes care following electronic feedback of treatment status to general practitioners: a cluster randomized controlled trial. Diabet Med. 2011 Mar;28(3):325-32. doi: 10.1111/j.1464-5491.2010.03178.x.
PubMed 21309841Guldberg TL, Vedsted P, Lauritzen T, Zoffmann V. Suboptimal quality of type 2 diabetes care discovered through electronic feedback led to increased nurse-GP cooperation. A qualitative study. Prim Care Diabetes. 2010 Apr;4(1):33-9. doi: 10.1016/j.pcd.2010.01.001. Epub 2010 Jan 21.
PubMed 20096659
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Electronic Feedback, a Tool for Quality Assurance of the Diabetic Care in General Practice
- ClinicalTrials.gov ID
- NCT01009528
- Acronym / sponsor ID
- 2008-41-2792
- Conditions
- Type 2 Diabetes
- Keywords
- Quality of care, General Practice, Electronic Feedback System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,458 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 6 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether electronic feedback to general practitioners on quality of Type 2-Diabetes care increases the quality of care measured on process and outcome measures contained in the national guidelines. Effect evaluation will be performed using a mixed method design.
Detailed description
Background: In an effort to optimize diabetes care in general practice, an electronical feedback system has been developed. The system will be evaluated both quantitative and qualitative.
Method: The general practitioners (GP´s) of the Region of Southern Denmark have been randomised to either admission or no admission to the electronic feedback system. The system was launched 1/3-2007 and ran for one year prior to evaluation.
Quantitative evaluation by assessment of the following end-points: Patients Hba1c-level, number of patients who have had their hba1c-level measured within the last year, cholesterol-level and number of patients who have had an eye examination within the last year.
Qualitative evaluation by interviewing GP´s who have had admission to the system.
Qualitative data have been collected through interviews with intervention GPs, designed to uncover motivational factors as well as barriers concerning the use of feedback on chronic care in general practice. Data are being analyzed.
Quantitative data are being gathered. Perspective: This project will shed light on the value of electronic feedback systems within chronic care in general practice.
Based on this project it will be possible to set up a system for automatic electronic monitoring and feedback of the quality of care in general practice, taking motivational factors of the GP s into account during implementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Electronic feedback system on diabetes careAdmission to electronic feedback system |
| control | No intervention | –Control group. No special attention |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prevalent Type 2-diabetes as confirmed by Primary Care Physician.
- Patient alive throughout the intervention period.
- GP actively working throughout the intervention period (not retired).
Key exclusion criteria (3 listed)
- death during intervention
- moved out of geographic area during intervention
- GP retired during intervention
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 |
|---|---|---|
| Electronic feedback system on diabetes careAlso: Electronic feedback system, Decission support systemAn electronic feedback system was introduced in randomized primary care clinics providing an overview of quality of care. The intervention ran for 15 months. | Device | Intervention |
Primary outcome
Outcome and process measures from the danish diabetes guideline
Time frame: 1/3 2007-1/6 2008
1 secondary outcome
Interview data concerning the impact of the electronic feedback system in the intervention clinics
Time frame: 1/3 2007-1/6 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2009.
- Background: PubMed 19419548Guldberg TL, Lauritzen T, Kristensen JK, Vedsted P. The effect of feedback to general practitioners on quality of care for people with type 2 diabetes. A systematic review of the literature. BMC Fam Pract. 2009 May 6;10:30. doi: 10.1186/1471-2296-10-30.
- Derived from this study: PubMed 21309841Guldberg TL, Vedsted P, Kristensen JK, Lauritzen T. Improved quality of Type 2 diabetes care following electronic feedback of treatment status to general practitioners: a cluster randomized controlled trial. Diabet Med. 2011 Mar;28(3):325-32. doi: 10.1111/j.1464-5491.2010.03178.x.
- Derived from this study: PubMed 20096659Guldberg TL, Vedsted P, Lauritzen T, Zoffmann V. Suboptimal quality of type 2 diabetes care discovered through electronic feedback led to increased nurse-GP cooperation. A qualitative study. Prim Care Diabetes. 2010 Apr;4(1):33-9. doi: 10.1016/j.pcd.2010.01.001. Epub 2010 Jan 21.
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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.
Torsten Lauritzen, MD, Dr. Med. study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic feedback system on diabetes care in people with Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.
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 3 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 9 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Outcome and process measures from the danish diabetes guideline (time frame: 1/3 2007-1/6 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01009528, which also lists 3 linked publications.
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 9 Nov 2009; AzTrials last refreshed its copy on 30 Oct 2026.