Novel Electronic Monitoring Devices (NEMD) to Monitor Adherence in Children With Asthma

NCT04289714 | Completed Results

• 1 other identifier: 239759
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To evaluate the accuracy of these devices and assess whether they impact on asthma control (quantitative study).

Conditions

Asthma in Children

Keywords

Asthma; Children; Adherence; Electronic Monitoring devices (EMD); Inhalers; Inhaled medication

Outcome Measures

Primary Outcomes (2)

• Acceptability Using Semi Structured Questionnaires in Focus Groups and Interviews

  Number of participant interviewed in focus groups and interviews

  16 weeks

• Number of Themes Generated by Participants Regarding Usage of the Devices

  The Primary outcome measure is largely qualitative and based on collective themes. As a result there are no numerical measurements that differ each of the devices. In terms of accuracy of each device adherence data was collected but differs for each device depending on its functionality

  16 weeks

Secondary Outcomes (1)

• Adherence to Inhaled Medication

  16 weeks

Study Arms (3)

R-DOT

EXPERIMENTAL

Remote Directly Observed Therapy

Device: Novel Electronic Monitoring Device

Haillie

EXPERIMENTAL

Smartinhaler Haillie

Device: Novel Electronic Monitoring Device

Rafi-tone/INCA

EXPERIMENTAL

Rafi-tone with Flo-tone /INCA

Device: Novel Electronic Monitoring Device

Interventions

Novel Electronic Monitoring Device DEVICE

Four Novel electronic Monitoring Devices were trialled

Haillie; R-DOT; Rafi-tone/INCA

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent obtained from parents/guardian/adolescents and/or assent from the child.
• Children aged between 6-16 years with a diagnosis of asthma attending the Royal Brompton and Harefield Difficult asthma clinic.
• Children on inhaled cortico-steroids
• Parents/ young person has a mobile phone which can download apps
• Paediatric respiratory nurses working in the difficult asthma team at Royal Brompton Hospital.

You may not qualify if:

• Unable to provide consent
• As a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study.
• Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures
• Children under the age of 6 years.
• Children not on inhaled cortico-steroid
• It is not anticipated that any children will be pregnant, however, if they are they will not be included in the study

Sponsors & Collaborators

• Imperial College London: lead
• Asthma UK: collaborator

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

The numbers completing in each arm was small to calculate robust quantitative analysis, however, it was a sufficient size for qualitative analysis which was the primary aim of the study. The study period was extended due to low completion rate.

Results Point of Contact

• Title: Sukeshi Makhecha
• Organization: Royal Brompton Hospital

s.makhecha@rbht.nhs.uk

0207-3528121

Study Officials

• Louise Fleming, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Pragmatic randomization based on inhaled medication
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility Pragmatic randomisation

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 28, 2020
• Study Start: October 12, 2018
• Primary Completion: May 18, 2019
• Study Completion: May 18, 2019
• Last Updated: October 27, 2020
• Results First Posted: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: 6 months from publication
• Access Criteria: For publication purposes by the Principal investigator and the study team

Locations

GB (1)