Extrait

Background and study aims The prevalence of diabetes has risen dramatically in recent years. It is estimated that there are up to half a million people in the UK who have undiagnosed diabetes and this figure is expected to rise. People with undiagnosed diabetes are at a higher risk of problems with the eyes, feet and kidneys as well as serious problems with the cardiovascular system such as strokes and heart attacks. Because of the increasing numbers of people with undiagnosed diabetes in the UK the government introduced a large-scale screening programme called NHS ‘health checks’. As part of this programme all people aged 40-75 are offered screening tests for diabetes, kidney disease and cardiovascular disease risk. These tests are usually carried out by a GP (doctor). We know that not all people eligible for these checks have taken up the invitation to have them. There is a significant proportion of the population who do not access healthcare through established routes and may be less likely to visit a GP or may not be registered with a GP at all. It is important that screening tests are made available to everyone. Community pharmacists are often seen as a ‘first port of call’ for people seeking medical advice. They provide ‘high street’ access to the majority of the population who will visit a pharmacy at least once a year. By offering screening tests for diabetes in pharmacies it is hoped that it may make it easier for people who have not had a diabetes test to have one done. We want to test whether community pharmacies are feasible sites for carrying out diabetes screening. We also want to find out whether a having a fingerpick blood test with the result immediately available means people are more likely to follow up a pharmacists advice to see a GP compared to filling out a questionnaire which assesses diabetes risk without needing to have a blood test. The aim of this study is to evaluate the level of uptake to further testing in participants who have a positive screening test result at their local pharmacy. Response rates will be compared between the two study groups. Other objectives are to compare the yield (numbers) diagnosed with either diabetes or impaired glucose regulation following a confirmatory test by a GP. Who can participate? Participants must be aged 40-75 (35-75 if south Asian due to the increased risk of diabetes), not diabetic, and should not have had a fasting test to screen for diabetes in the previous 12 months. What does the study involve? Participants are randomly allocated to one of two groups: 1. Near patient test arm Once consent has been given, participants will be asked to fill out a questionnaire to assess diabetes risk. Should the participant score 16 points or above they will be immediately be offered a fingerprick test for HbA1c at the pharmacy. If their HbA1c result is greater or equal to 6% (42mmol/l) they will be given a print out of their results and asked to visit their GP for a follow-up test. Regardless of the participants’ diabetes risk status the results will be sent to their GP with a recommendation on the appropriate course of follow up. 2. Risk score only arm Once consent has been given, participants will be asked to fill out a questionnaire to assess diabetes risk. Should the participant score 16 points or above they will be given a print out of their results and asked to visit their GP for a follow-up test. Regardless of the participants diabetes risk status the results will again be sent to their GP with a recommendation on the appropriate course of follow up. What are the possible benefits and risks of participating? Participants will be able to get screened for diabetes without having to make an appointment with their GP. Some patients may not want their GP to know if they have been diagnosed with diabetes due to implications it may have on employment. This will be made clear to participants before they are asked to give consent. Where is the study run from? The study will be run within Leicester, UK. When is the study starting and how long is it expected to run for? The study started in March 2011. It is expected that recruitment will be completed in March 2014. Who is funding the study? Merck Sharp & Dohme Limited, NHS Leicester City and the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care - Leicestershire, Northamptonshire and Rutland (UK). Who is the main contact? Andrew Willis, study coordinator [email protected]

Critère d'inclusion

• Early detection of type 2 diabetes

Liens

• isrctn
• ictrp