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
Sponsor:
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
  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 April 17, 2014