Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04289714 |
| Other study ID # |
239759 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 12, 2018 |
| Est. completion date |
May 18, 2019 |
Study information
| Verified date |
October 2020 |
| Source |
Imperial College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a feasibility study to assess novel electronic monitoring devices for monitoring
adherence in children with asthma who are on inhaled corticosteroids (ICS)
It is a mixed method (quantitative and qualitative) open label, pragmatic randomised
feasibility study with two main aims:
1. To assess the feasibility of 4 novel electronic monitoring devices in children aged 6-16
years with asthma, in terms of usability and acceptability by patients/ guardians and
healthcare professionals (qualitative study)
2. To evaluate the accuracy of these devices and assess whether they impact on asthma
control (quantitative study).
The duration of study is 16 weeks.
Description:
This was an open label, block randomised (10 in each block), mixed method (quantitative and
qualitative) study to be conducted for a period of up to 16 weeks
Children aged between 6-16 years with asthma attending the paediatric respiratory difficult
asthma clinic will be recruited into the study and randomly allocated to one of three arms
using block randomisation matched for age and size of group. Children will be assigned to
trial one of the following four NEMD's to be tested:
1. Block 1 (10): Smart-inhaler Plus™ (Adherium, New Zealand)
• This measures inhalation usually flow sensors and is the next generation of a
currently commercially available EMD
2. Block 2a (5) : Flo-Tone (Clement Clarke, UK) plus Rafi-tone, acoustic enabled Smartphone
App (clin-e-cal, UK) for children aged 6 - 11 years • The Flo-Tone attaches to a Metered
Dose Inhaler (MDI) and makes a sound when the inhaler is used correctly. Rafi-tone is a
Smartphone App that detects the sound and activates a game The game is aimed at younger
children and therefore children aged 6 - 11 years will be randomised to this block.
Block 2b (5) : Inhaler Compliance Assessment (INCA™) device (INCA, Ireland)
- This is an audio recording device which attaches to a Discus dry powder inhaler.
Analysis of the digital audio recordings enables objective assessment of inhaler use and
technique. As it can only be used with a Discus only children ≥ 12 years will be
randomised to this block
3. Block 3: Video and Remote Directly Observed treatment (rDOT)
- Children are filmed on a Smartphone using their inhaler. The clip is then automatically
uploaded via a Smartphone App (Continga, UK) and reviewed by a Clinical Nurse Specialist
to ensure inhaler technique is correct.
Recruitment :
The aim was to recruit 30 children into the study; 10 per block, and 5 per block aged 6-11
years and 5 aged 12-16 years for the INCA/Rafi-tone arm. However, due to low number of
participants completing the study, ethics approval was sought to extend the study. As a
result 35 participants were recruited at the end of the study period.
Visit 1:Novel electronic monitoring device (NEMD) issued Routine clinical care assessments
will be carried out at the end of the study period as below, including asthma control test
(ACT) or the childhood asthma control test (cACT), exhaled nitric oxide (FeNO) and spirometry
(FEV1 and BDR) .
Patient/parent/Carer will be invited to take part in the study. Information regarding the
study and its objectives will be communicated to the Patient/parent/carer in both oral and
written form using patient information leaflets.
All children will be issued with a novel electronic monitoring device which will be attached
to the child's usual inhaler or require an app on their mobile phone as described above.
Parents and children will be provided information and advice on the use of the novel
electronic monitoring device and asked to conduct up to 16 weeks of home monitoring using
their allocated NEMD on their first visit.
Information on how to contact the team in case of any problems will be related to the
participant in both oral and written form.
The data will be stored electronically and downloaded at the next clinic visit. Contact by
telephone will be made at day 7-14 to ensure that the device is working and to answer any
other queries then at week 6-7 to determine if the device is being used appropriately and to
answer any related questions.
Week 1 - for the rDOT arm, adherence data will be downloaded to check for consistencies in
inhaler technique. If inhaler technique is inaccurate, the participants will be called by the
respiratory nurse specialists to advise on correct technique. This will be documented as part
of the data collection.
Week 4 - All devices, adherence data will be downloaded and checked to ensure that the
devices are working correctly.
Visit 2: up to 12 weeks of adherence data collection Routine clinical care assessments will
be carried out at the end of the study period as below, including asthma control test (ACT)
or the childhood asthma control test (cACT), exhaled nitric oxide and spirometry (FEV1 and
BDR) .
Adherence data will downloaded at the end of the study period and stored electronically.
Visit 3: Focus group or one to one interviews The participants and their carers will be
invited to a face to face focus group interview, or a one to one interview, depending on
their availability at the end of the study period. The focus group and one to one interviews
will utilise a semi structured questionnaire, to provide qualitative feedback on the
acceptability and usability of the devices.
A separate focus group meeting will also be conducted with the paediatric respiratory nurses
who are part of the Multi disciplinary Team (MDT) to assess their views on the devices used
as they routinely provided all asthma devices and are also involved in downloading data from
other devices that the investigators would use as part of routine care (smart-inhaler). They
will also be consented to take part in the study Where possible a second researcher from
University College London (UCL), Christina Pearce will sit in the focus groups discussion and
interviews to ensure there is no bias.
The conversations from the focus group and one to one interviews will be transcribed and
coded into themes. The investigators will utilise an external company for transcribing the
conversations called 1st Class.
Analysis
Qualitative:
The focus group and one to one interviews will be audio recorded, transcribed and put into
themes to conduct an inductive thematic analysis. 25% of the transcripts (8) will be double
coded by an independent researcher from UCL, Dr Amy Chan, experienced in qualitative research
to ensure that the correct themes have been used and to ensure that there is no bias.
The focus group and one to one interviews will be used to assess the usability and
acceptability of the devices
Quantitative:
The amount of usable data from each device will be quantified and compared. This will provide
data on the perceived accuracy of the device.
The quantitative and qualitative results will be amalgamated and an evidence report prepared
to assess the feasibility of each device.
An expert panel will be convened to select the most appropriate device to take forward to a
larger randomised controlled trial to assess the impact of the device on adherence in
children with asthma.
