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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: Self Assessment; Other: Electronic risk score

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.

• Study Type: Interventional
• Enrollment (Actual): 432
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom
      • Leicester City PCT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Increase in response rates to invitation to 2nd stage blood test	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Increase in yield of OGTT positive results through filtering of high risk participants that pass 1st and 2nd stage screens	12

Collaborators and Investigators

• Sponsor: University of Leicester
• Collaborators: University Hospitals, Leicester
• Investigators: Principal Investigator: Kamlesh Khunti, MD, University of Leicester

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 30, 2009
• First Submitted That Met QC Criteria: July 30, 2009
• First Posted (Estimate): July 31, 2009

Study Record Updates

• Last Update Posted (Actual): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Diabetes; Screening; Risk; Self assessment
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus
• Other Study ID Numbers: 0132