Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes (ATTEND)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University Hospitals, Leicester.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
University Hospitals, Leicester
Collaborator:
University of Leicester
Information provided by:
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT00950313
First received: July 30, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
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Purpose
The purpose of this study is to establish the most effective method of increasing attendance to screening of type 2 Diabetes within a primary care setting within the backdrop of the NHS Health Check programme.
| Condition | Intervention |
|---|---|
|
Diabetes |
Other: Self Assessment Other: Electronic risk score |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes |
Resource links provided by NLM:
Further study details as provided by University Hospitals, Leicester:
Primary Outcome Measures:
- Increase in response rates to invitation to 2nd stage blood test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Increase in yield of OGTT positive results through filtering of high risk participants that pass 1st and 2nd stage screens [ Time Frame: 12 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 480 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Self Assessment
Patients are approached and asked to complete a risk score that will determine their current risk of diabetes and the likelihood of requiring further testing.
|
Other: Self Assessment
Self assessment used to determine current risk of diabetes and likelihood of requiring further testing
|
|
Active Comparator: Electronic risk score
Patients diabetes riks is determined based on their data held on practice systems. Patients are then invited for further testing based on this score.
|
Other: Electronic risk score
Patients current risk of diabetes is determined by a electronic risk algorithm. They are then invited to attend fof further testing.
|
Detailed Description:
The University Hospitals of Leicester and The University of Leicester have developed a self-assessment risk score and a practice data risk score that can be used in a variety of setting to detect undiagnosed diabetes and impaired glucose regulation. This is done to establish a simple and effective 1st stage screen to identify those people at risk of diabetes and engage the public to increase the number of high risk individuals attending screening invitations but reducing the overall number of oral glucose tolerance tests. This study aims to test in a pragmatic way the use of such tools in a primary care setting administered by primary care staff as part of the NHS Health Check programme.
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 40-75 years old (30 -75 years old if South Asian origin)
Exclusion Criteria:
- Current diagnosis of diabetes
- Terminal illness or mental incapacity
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950313
Contacts
| Contact: Stephen Hiles | 01162525449 | slh66@le.ac.uk |
| Contact: Andy Willis | 01162525429 | aw187@le.ac.uk |
Locations
| United Kingdom | |
| Leicester City PCT | Not yet recruiting |
| Leicester, Leicestershire, United Kingdom | |
Sponsors and Collaborators
University Hospitals, Leicester
University of Leicester
Investigators
| Principal Investigator: | Kamlesh Khunti, MD | University of Leicester |
More Information
No publications provided
| Responsible Party: | Kamlesh Khunti, University of Leicester |
| ClinicalTrials.gov Identifier: | NCT00950313 History of Changes |
| Other Study ID Numbers: | CLAHRC ED DIAB01 |
| Study First Received: | July 30, 2009 |
| Last Updated: | July 30, 2009 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University Hospitals, Leicester:
|
Diabetes Screening Risk Self assessment |
Additional relevant MeSH terms:
|
Diabetes Mellitus Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013