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

NCT ID: NCT00950313

Last Updated: 2020-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 432 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-07-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Self Assessment

Intervention Type: OTHER

Self assessment used to determine current risk of diabetes and likelihood of requiring further testing

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.

Group Type: ACTIVE_COMPARATOR

Electronic risk score

Intervention Type: OTHER

Patients current risk of diabetes is determined by a electronic risk algorithm. They are then invited to attend fof further testing.

Interventions

Self Assessment

Self assessment used to determine current risk of diabetes and likelihood of requiring further testing

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals, Leicester

OTHER

Sponsor Role: collaborator

University of Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kamlesh Khunti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Locations

Leicester City PCT

Leicester, Leicestershire, United Kingdom

Countries

United Kingdom

Other Identifiers

0132

Identifier Type: -

Identifier Source: org_study_id