Novel Electronic Monitoring Devices (NEMD) to Monitor Adherence in Children With Asthma
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Novel Electronic Monitoring Device
Intervention type(s): Device
Intervention description(s): Four Novel electronic Monitoring Devices were trialled
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Feasibility Pragmatic randomisation
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Asthma; Children; Adherence; Electronic Monitoring devices (EMD); Inhalers; Inhaled medication