NCT00950313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
432

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2009

Completed
1.7 years until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 30, 2020

Status Verified

July 1, 2009

Enrollment Period

3.3 years

First QC Date

July 30, 2009

Last Update Submit

January 29, 2020

Conditions

Diabetes

Keywords

DiabetesScreeningRiskSelf assessment

Outcome Measures

Primary Outcomes (1)

  • Increase in response rates to invitation to 2nd stage blood test

    12 months

Secondary Outcomes (1)

  • Increase in yield of OGTT positive results through filtering of high risk participants that pass 1st and 2nd stage screens

    12

Study Arms (2)

Self Assessment

ACTIVE COMPARATOR

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

Electronic risk score

ACTIVE COMPARATOR

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

Interventions

Self AssessmentOTHER

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

Self Assessment
Electronic risk scoreOTHER

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

Electronic risk score

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old (30 -75 years old if South Asian origin)

You may not qualify if:

  • Current diagnosis of diabetes
  • Terminal illness or mental incapacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leicester City PCT

Leicester, Leicestershire, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Diagnostic Self Evaluation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Kamlesh Khunti, MD

    University of Leicester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2009

First Posted

July 31, 2009

Study Start

April 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

January 30, 2020

Record last verified: 2009-07

Locations

GB(1)