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Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes (ATTEND)

This study has been completed.
Sponsor:
Collaborator:
University Hospitals, Leicester
Information provided by (Responsible Party):
University of Leicester
ClinicalTrials.gov Identifier:
NCT00950313
First received: July 30, 2009
Last updated: November 12, 2014
Last verified: July 2009

July 30, 2009
November 12, 2014
April 2011
July 2014   (final data collection date for primary outcome measure)
Increase in response rates to invitation to 2nd stage blood test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00950313 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes
Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Diabetes
  • Other: Self Assessment
    Self assessment used to determine current risk of diabetes and likelihood of requiring further testing
  • 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.
  • 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.
    Intervention: Other: Self Assessment
  • 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.
    Intervention: Other: Electronic risk score
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
432
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00950313
CLAHRC ED DIAB01
Yes
University of Leicester
University of Leicester
University Hospitals, Leicester
Principal Investigator: Kamlesh Khunti, MD University of Leicester
University of Leicester
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP