The DEFINE Study

D etermining the E ffectiveness of an online F eNO-guided asthma management IN terv E ntion in primary care

The primary objective of this study is to determine whether use of an online FeNO-guided asthma management intervention in primary care reduces the proportion of asthma patients who experience an acute exacerbation of asthma over a 12-month period.

Taking part will involve the following for your practice:

  1. Complete a short questionnaire and attend a training session about taking part in the DEFINE trial;
  2. Complete brief online training on measurement and interpretation of FeNO.
  3. Database search to identify potentially eligible patients who are due for their asthma review.
  4. Screen the medical notes of patients identified by the database search.
  5. Send out study invites by letter, email, phone or text message.
  6. Deliver FeNO web tool intervention during routine asthma reviews for patients randomised to the intervention arm.  Deliver asthma reviews according to usual care (i.e. without measuring FeNO or using the FeNO web tool intervention) to patients randomised to the usual care arm.

GCP training is not essential because the research team will be able to help with research-related procedures (e.g. obtaining consent/assent) if needed.

Reimbursement for service support, research and excess treatment costs will be provided.

Practices who recruit 25 or more patients within 6 months of site initiation will be allowed to keep their FeNO analyser (NIOX VERO®, RRP approx. £2700 plus VAT)

The primary objective of this study is to determine whether use of an online FeNO-guided asthma management intervention in primary care reduces the proportion of asthma patients who experience an acute exacerbation of asthma over a 12-month period.

Taking part will involve the following for your practice :

1. Complete a s hort questionnaire and attend a training session about taking part in the DEFINE trial;

2. Complete brief online training on measurement and interpretation of FeNO.

3. Database search to identify potentially eligible patients who are due for their asthma review.

4. Screen the medical notes of patients identified by the database search.

5. Send out study invites by letter, email, phone or text message.

6. Deliver FeNO web tool intervention during routine asthma reviews for patients randomised to the intervention arm. Deliver asthma reviews according to usual care (i.e. without measuring FeNO or using the FeNO web tool intervention) to patients randomised to the usual care arm.

GCP training is not essential because the research team will be able to help with research-related procedures (e.g. obtaining consent/assent) if needed. .

Reimbursement for service support, research and excess treatment costs will be provided.

Practices who recruit 25 or more patients within 6 months of site initiation will be allowed to keep their FeNO analyser (NIOX VERO ® , RRP approx. £2700 plus VAT)


FURTHER INFORMATION AND CONTACT DETAILS:

Please contact the research team if you would like further information.

Louise Jones (Clinical Trial Manager)

E: define@phc.ox.ac.uk