Back to resultsAssessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes (ATTEND)
Primary Purpose
Diabetes
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Self Assessment
Electronic risk score
Sponsored by
About this trial
This is an interventional screening trial for Diabetes focused on measuring Diabetes, Screening, Risk, Self assessment
Eligibility 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
Sites / Locations
- Leicester City PCT
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Self Assessment
Electronic risk score
Arm Description
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.
Patients diabetes riks is determined based on their data held on practice systems. Patients are then invited for further testing based on this score.
Outcomes
Primary Outcome Measures
Increase in response rates to invitation to 2nd stage blood test
Secondary Outcome Measures
Increase in yield of OGTT positive results through filtering of high risk participants that pass 1st and 2nd stage screens
Full Information
NCT ID
NCT00950313
First Posted
July 30, 2009
Last Updated
January 29, 2020
Sponsor
University of Leicester
Collaborators
University Hospitals, Leicester
1. Study Identification
Unique Protocol Identification Number
NCT00950313
Brief Title
Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes
Acronym
ATTEND
Official Title
Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Leicester
Collaborators
University Hospitals, Leicester
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
Diabetes, Screening, Risk, Self assessment
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
432 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self Assessment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Electronic risk score
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Self Assessment
Intervention Description
Self assessment used to determine current risk of diabetes and likelihood of requiring further testing
Intervention Type
Other
Intervention Name(s)
Electronic risk score
Intervention Description
Patients current risk of diabetes is determined by a electronic risk algorithm. They are then invited to attend fof further testing.
Primary Outcome Measure Information:
Title
Increase in response rates to invitation to 2nd stage blood test
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Increase in yield of OGTT positive results through filtering of high risk participants that pass 1st and 2nd stage screens
Time Frame
12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamlesh Khunti, MD
Organizational Affiliation
University of Leicester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leicester City PCT
City
Leicester
State/Province
Leicestershire
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes
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