Determining the Effectiveness of an online FeNO-guided asthma management INtervEntion 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:
- Complete a short questionnaire and attend a training session about taking part in the DEFINE trial;
- Complete brief online training on measurement and interpretation of FeNO.
- Database search to identify potentially eligible patients who are due for their asthma review.
- Screen the medical notes of patients identified by the database search.
- Send out study invites by letter, email, phone or text message.
- 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)
<span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;
line-height:107%;font-family:"Helvetica",sans-serif;color:#1D3850"><span style="mso-prop-change:"Michelle Van Velthoven" 20220426T1621"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:21">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.</ins></span></span></span></span><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;line-height:107%;font-family:
"Helvetica",sans-serif;color:#1D3850"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-27T18:09"><p></p></ins></span></span></p>
<p style="background:white"><span style="font-size:12.0pt;
mso-bidi-font-size:10.0pt;line-height:107%;font-family:"Helvetica",sans-serif;
color:#1D3850"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:24">Taking part will involve the following for your practice</ins></span><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:22">:</ins></span><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:21"><p></p></ins></span></span></p>
<p style="margin-left:0cm !msorm;text-indent:
0cm !msorm;mso-list:none !msorm;mso-style-name:Normal !msorm;text-indent:-18.0pt;
mso-list:l0 level1 lfo1;background:white;mso-prop-change:"Michelle Van Velthoven" 20220426T1621"><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;line-height:107%;font-family:
"Helvetica",sans-serif;mso-fareast-font-family:Helvetica;color:#1D3850"><span style="mso-list:Ignore">1.<span style="font:7.0pt "Times New Roman"">
</span></span></span><span style="font-weight:normal !msorm"><b style="mso-bidi-font-weight:normal"><span style="font-size:12.0pt;mso-bidi-font-size:
10.0pt;line-height:107%;font-family:"Helvetica",sans-serif;color:#1D3850"><span style="mso-prop-change:"Michelle Van Velthoven" 20220502T1546"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-05-02T15:46">Complete a s</ins></span></span></span></b></span><b style="mso-bidi-font-weight:normal"><span style="font-size:12.0pt;mso-bidi-font-size:
10.0pt;line-height:107%;font-family:"Helvetica",sans-serif;color:#1D3850"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-05-02T15:46">hort questionnaire and attend<span style="font-weight:normal !msorm"><span style="mso-prop-change:"Michelle Van Velthoven" 20220502T1546">
a</span></span></ins></span><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-05-02T15:47"> </ins></span><span style="font-weight:normal !msorm"><span style="mso-prop-change:"Michelle Van Velthoven" 20220502T1546"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-05-02T15:46">training session</ins></span></span></span></span></b><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;line-height:107%;font-family:
"Helvetica",sans-serif;color:#1D3850"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-05-02T15:46"> about
taking part in the DEFINE trial;<span style="font-weight:bold !msorm;
mso-bidi-font-weight:normal !msorm"><span style="mso-prop-change:"Michelle Van Velthoven" 20220502T1546"><p></p></span></span></ins></span></span></p>
<p style="text-indent:-18.0pt;mso-list:l0 level1 lfo1;
background:white"><span style="font-size:12.0pt;
mso-bidi-font-size:10.0pt;line-height:107%;font-family:"Helvetica",sans-serif;
mso-fareast-font-family:Helvetica;color:#1D3850"><span style="mso-list:Ignore">2.<span style="font:7.0pt "Times New Roman""> </span></span></span><b style="mso-bidi-font-weight:normal"><span style="font-size:12.0pt;mso-bidi-font-size:
10.0pt;line-height:107%;font-family:"Helvetica",sans-serif;color:#1D3850"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-05-02T15:46">Complete brief online training</ins></span></span></b><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;line-height:107%;font-family:
"Helvetica",sans-serif;color:#1D3850"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-05-02T15:46"> on
measurement and interpretation of FeNO.<p></p></ins></span></span></p>
<p style="margin-left:0cm !msorm;text-indent:
0cm !msorm;mso-list:none !msorm;mso-style-name:Normal !msorm;text-indent:-18.0pt;
mso-list:l0 level1 lfo1;background:white;mso-prop-change:"Michelle Van Velthoven" 20220426T1621"><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;line-height:107%;font-family:
"Helvetica",sans-serif;mso-fareast-font-family:Helvetica;color:#1D3850"><span style="mso-list:Ignore">3.<span style="font:7.0pt "Times New Roman"">
</span></span></span><span style="font-size:11.0pt !msorm;line-height:
107% !msorm;font-family:"Calibri",sans-serif !msorm;mso-ascii-theme-font:minor-latin !msorm;
mso-hansi-theme-font:minor-latin !msorm;mso-bidi-font-family:"Times New Roman" !msorm;
mso-bidi-theme-font:minor-bidi !msorm;color:windowtext !msorm;font-weight:normal !msorm"><b style="mso-bidi-font-weight:normal"><span style="font-size:12.0pt;mso-bidi-font-size:
10.0pt;line-height:107%;font-family:"Helvetica",sans-serif;color:#1D3850"><span style="mso-prop-change:"Michelle Van Velthoven" 20220426T1622"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:21">Database search</ins></span></span></span></b></span><span style="font-size:11.0pt !msorm;line-height:107% !msorm;font-family:"Calibri",sans-serif !msorm;
mso-ascii-theme-font:minor-latin !msorm;mso-hansi-theme-font:minor-latin !msorm;
mso-bidi-font-family:"Times New Roman" !msorm;mso-bidi-theme-font:minor-bidi !msorm;
color:windowtext !msorm"><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;
line-height:107%;font-family:"Helvetica",sans-serif;color:#1D3850"><span style="mso-prop-change:"Michelle Van Velthoven" 20220426T1621"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:21"> to identify potentially eligible patients who are
due for their asthma review.<p></p></ins></span></span></span></span></p>
<p style="margin-left:0cm !msorm;text-indent:
0cm !msorm;mso-list:none !msorm;mso-style-name:Normal !msorm;text-indent:-18.0pt;
mso-list:l0 level1 lfo1;background:white;mso-prop-change:"Michelle Van Velthoven" 20220426T1621"><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;line-height:107%;font-family:
"Helvetica",sans-serif;mso-fareast-font-family:Helvetica;color:#1D3850"><span style="mso-list:Ignore">4.<span style="font:7.0pt "Times New Roman"">
</span></span></span><span style="font-size:11.0pt !msorm;line-height:
107% !msorm;font-family:"Calibri",sans-serif !msorm;mso-ascii-theme-font:minor-latin !msorm;
mso-hansi-theme-font:minor-latin !msorm;mso-bidi-font-family:"Times New Roman" !msorm;
mso-bidi-theme-font:minor-bidi !msorm;color:windowtext !msorm;font-weight:normal !msorm"><b style="mso-bidi-font-weight:normal"><span style="font-size:12.0pt;mso-bidi-font-size:
10.0pt;line-height:107%;font-family:"Helvetica",sans-serif;color:#1D3850"><span style="mso-prop-change:"Michelle Van Velthoven" 20220426T1622"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:21">Screen the medical notes</ins></span></span></span></b></span><span style="font-size:11.0pt !msorm;line-height:107% !msorm;font-family:"Calibri",sans-serif !msorm;
mso-ascii-theme-font:minor-latin !msorm;mso-hansi-theme-font:minor-latin !msorm;
mso-bidi-font-family:"Times New Roman" !msorm;mso-bidi-theme-font:minor-bidi !msorm;
color:windowtext !msorm"><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;
line-height:107%;font-family:"Helvetica",sans-serif;color:#1D3850"><span style="mso-prop-change:"Michelle Van Velthoven" 20220426T1621"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:21"> of patients identified by the database search.<p></p></ins></span></span></span></span></p>
<p style="margin-left:0cm !msorm;text-indent:
0cm !msorm;mso-list:none !msorm;mso-style-name:Normal !msorm;text-indent:-18.0pt;
mso-list:l0 level1 lfo1;background:white;mso-prop-change:"Michelle Van Velthoven" 20220426T1621"><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;line-height:107%;font-family:
"Helvetica",sans-serif;mso-fareast-font-family:Helvetica;color:#1D3850"><span style="mso-list:Ignore">5.<span style="font:7.0pt "Times New Roman"">
</span></span></span><span style="font-size:11.0pt !msorm;line-height:
107% !msorm;font-family:"Calibri",sans-serif !msorm;mso-ascii-theme-font:minor-latin !msorm;
mso-hansi-theme-font:minor-latin !msorm;mso-bidi-font-family:"Times New Roman" !msorm;
mso-bidi-theme-font:minor-bidi !msorm;color:windowtext !msorm;font-weight:normal !msorm"><b style="mso-bidi-font-weight:normal"><span style="font-size:12.0pt;mso-bidi-font-size:
10.0pt;line-height:107%;font-family:"Helvetica",sans-serif;color:#1D3850"><span style="mso-prop-change:"Michelle Van Velthoven" 20220426T1622"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:21">Send out study invites</ins></span></span></span></b></span><span style="font-size:11.0pt !msorm;line-height:107% !msorm;font-family:"Calibri",sans-serif !msorm;
mso-ascii-theme-font:minor-latin !msorm;mso-hansi-theme-font:minor-latin !msorm;
mso-bidi-font-family:"Times New Roman" !msorm;mso-bidi-theme-font:minor-bidi !msorm;
color:windowtext !msorm"><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;
line-height:107%;font-family:"Helvetica",sans-serif;color:#1D3850"><span style="mso-prop-change:"Michelle Van Velthoven" 20220426T1621"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:21"> by letter, email, phone or text message.<p></p></ins></span></span></span></span></p>
<p style="margin-left:0cm !msorm;text-indent:
0cm !msorm;mso-list:none !msorm;mso-style-name:Normal !msorm;text-indent:-18.0pt;
mso-list:l0 level1 lfo1;background:white;mso-prop-change:"Michelle Van Velthoven" 20220426T1621"><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;line-height:107%;font-family:
"Helvetica",sans-serif;mso-fareast-font-family:Helvetica;color:#1D3850"><span style="mso-list:Ignore">6.<span style="font:7.0pt "Times New Roman"">
</span></span></span><span style="font-size:11.0pt !msorm;line-height:
107% !msorm;font-family:"Calibri",sans-serif !msorm;mso-ascii-theme-font:minor-latin !msorm;
mso-hansi-theme-font:minor-latin !msorm;mso-bidi-font-family:"Times New Roman" !msorm;
mso-bidi-theme-font:minor-bidi !msorm;color:windowtext !msorm;font-weight:normal !msorm"><b style="mso-bidi-font-weight:normal"><span style="font-size:12.0pt;mso-bidi-font-size:
10.0pt;line-height:107%;font-family:"Helvetica",sans-serif;color:#1D3850"><span style="mso-prop-change:"Michelle Van Velthoven" 20220426T1622"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:21">Deliver FeNO web tool intervention</ins></span></span></span></b></span><span style="font-size:11.0pt !msorm;line-height:107% !msorm;font-family:"Calibri",sans-serif !msorm;
mso-ascii-theme-font:minor-latin !msorm;mso-hansi-theme-font:minor-latin !msorm;
mso-bidi-font-family:"Times New Roman" !msorm;mso-bidi-theme-font:minor-bidi !msorm;
color:windowtext !msorm"><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;
line-height:107%;font-family:"Helvetica",sans-serif;color:#1D3850"><span style="mso-prop-change:"Michelle Van Velthoven" 20220426T1621"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:21"> during routine asthma reviews for patients
randomised to the intervention arm.</ins></span></span></span></span><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;line-height:107%;font-family:
"Helvetica",sans-serif;color:#1D3850"><span><ins cite="mailto:kay%20wang" datetime="2022-05-06T12:17"><span style="mso-spacerun:yes"> </span>Deliver asthma reviews according to usual
care</ins></span><span><ins cite="mailto:kay%20wang" datetime="2022-05-06T12:18"> (i.e. without measuring FeNO or using the FeNO web
tool intervention)</ins></span><span><ins cite="mailto:kay%20wang" datetime="2022-05-06T12:17"> to patients </ins></span><span><ins cite="mailto:kay%20wang" datetime="2022-05-06T12:18">randomised</ins></span><span><ins cite="mailto:kay%20wang" datetime="2022-05-06T12:17"> </ins></span><span><ins cite="mailto:kay%20wang" datetime="2022-05-06T12:18">to the
usual care arm.</ins></span><span style="font-size:10.0pt !msorm;line-height:
107% !msorm"><span style="mso-prop-change:"Michelle Van Velthoven" 20220426T1621"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:18"><p></p></ins></span></span></span></span></p>
<p style="tab-stops:list 18.0pt !msorm;background:white;
mso-prop-change:"Michelle Van Velthoven" 20220426T1626"><span style="font-size:
12.0pt;mso-bidi-font-size:10.0pt;line-height:107%;font-family:"Helvetica",sans-serif;
color:#1D3850;mso-bidi-font-weight:bold"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-29T10:59">GCP training</ins></span><span><ins cite="mailto:kay%20wang" datetime="2022-05-06T12:18"> is not
essential</ins></span><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-29T10:59"> because
the research team will be able to help with </ins></span><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-29T11:00">research-related
procedures (e.g. obtaining consent/assent)</ins></span><span><ins cite="mailto:kay%20wang" datetime="2022-05-06T12:19"> if needed.</ins></span><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-29T11:00"><span><del cite="mailto:kay%20wang" datetime="2022-05-06T12:19">.</del></span></ins></span><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-29T10:59"><p></p></ins></span></span></p>
<p style="tab-stops:list 18.0pt !msorm;background:white;
mso-prop-change:"Michelle Van Velthoven" 20220426T1626"><span style="font-weight:
bold !msorm;mso-bidi-font-weight:normal !msorm"><span style="font-size:12.0pt;
mso-bidi-font-size:10.0pt;line-height:107%;font-family:"Helvetica",sans-serif;
color:#1D3850;mso-bidi-font-weight:bold"><span style="mso-prop-change:"Michelle Van Velthoven" 20220426T1637"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:37"><span style="mso-bidi-font-weight:bold !msorm">Reimbursement</span></ins></span></span></span></span><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;line-height:107%;font-family:
"Helvetica",sans-serif;color:#1D3850;mso-bidi-font-weight:bold"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:38"> for service support, research and excess treatment
costs</ins></span><span style="font-weight:bold !msorm;mso-bidi-font-weight:
normal !msorm"><span style="mso-prop-change:"Michelle Van Velthoven" 20220426T1637"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:37"><span style="mso-bidi-font-weight:bold !msorm">
will be provided. </span></ins></span></span></span><span style="font-weight:
bold !msorm;mso-bidi-font-weight:normal !msorm"><span style="mso-prop-change:
"Michelle Van Velthoven" 20220426T1637"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:37"><p></p></ins></span></span></span></span></p>
<p style="tab-stops:list 18.0pt !msorm;background:white;
mso-prop-change:"Michelle Van Velthoven" 20220426T1626"><span style="font-size:
10.0pt !msorm;line-height:107% !msorm"><b><span style="font-size:12.0pt;
mso-bidi-font-size:10.0pt;line-height:107%;font-family:"Helvetica",sans-serif;
color:#1D3850"><span style="mso-prop-change:"Michelle Van Velthoven" 20220426T1626"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:26">Practices who recruit 25 or more patients within 6
months of site initiation will be allowed to keep their FeNO analyser (NIOX
VERO</ins></span></span></span></b></span><span style="font-size:10.0pt !msorm;
line-height:107% !msorm"><b><sup><span style="font-size:12.0pt;mso-bidi-font-size:
10.0pt;line-height:107%;font-family:"Helvetica",sans-serif;color:#1D3850"><span style="mso-prop-change:"Michelle Van Velthoven" 20220426T1626"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:26">®</ins></span></span></span></sup></b></span><span style="font-size:10.0pt !msorm;line-height:107% !msorm"><b><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;line-height:107%;font-family:
"Helvetica",sans-serif;color:#1D3850"><span style="mso-prop-change:"Michelle Van Velthoven" 20220426T1626"><span><ins cite="mailto:Michelle%20Van%20Velthoven" datetime="2022-04-26T16:26">, RRP approx. £2700 plus VAT)</ins></span></span></span></b></span><b><span style="font-size:12.0pt;mso-bidi-font-size:10.0pt;line-height:107%;font-family:
"Helvetica",sans-serif;color:#1D3850"><p></p></span></b></p><br /></div>
