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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Other: Self Assessment
* Other: Electronic risk score


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self Assessment<br>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<br>* Self assessment used to determine current risk of diabetes and likelihood of requiring further testing<br>|
| Active Comparator: Electronic risk score<br>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<br>* Patients current risk of diabetes is determined by a electronic risk algorithm. They are then invited to attend fof further testing.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Screening, Risk, Self assessment