Self-care, Remote Monitoring and Elearning for Children and Young People With Asthma

NCT05972226 | Completed

• 1 other identifier: SCH-2238
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is a long-term condition in children, often managed by general practitioners (GPs) in primary care but some children with asthma need hospital treatment and care by experienced paediatricians and nurses. The positive effects of treatment for childhood asthma are well-documented however, less than 50% children take their medications regularly as prescribed. As well as causing poor control of asthma symptoms, failing to take medication as prescribed is a problem that is causing huge cost and wastage to the NHS. Some of the barriers to taking medications as prescribed include people's beliefs about their illness or medications and forgetting or being too busy. These barriers can be addressed by providing education, reminders and incentives. Monitoring medication usage is complex but studies have shown that use of electronic monitoring devices with education does improve the number of asthma attacks. Digital solutions for asthma self-care, including "smart-inhalers" that monitor medication usage and Apps for remote monitoring and self-management are likely to transform health services by providing supported self-management, prioritisation of the more unwell patients and reductions in hospital visits. Asthma + me, a digital self-care solution has been developed by Aseptika Ltd, in consultation with Sheffield Children's Hospital, to support children with asthma. It uses a monitoring device that connects wirelessly to the Asthma +me App and monitors medication usage, providing education tips, reminders and incentives. In this project, 15 children (and their families) will trial Asthma + me with a PUFFClicker and a 3-4 hour education session and report what worked and what didn't using structured interviews and questionnaires. At the same time the investigators will map out the number of patients that could potentially use this solution to self-manage their asthma, with the support of the hospital, until they are ready to be discharged back to their GP.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Acceptability

  Acceptability of the Asthma and Me software, the PUFFClicker and the Education package, as assessed by the patient/parent, clinician and teacher using investigator designed questionnaires

  17 months

• Barriers to implementation of the Asthma and Me software

  Barriers to implementation of the Asthma and Me software, the PUFFClicker and the Education package, as assessed by the patient/parent, clinician and teacher using investigator designed questionnaires

  17 months

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion Criteria: 1. Age 5 to 15 years 11 months 2. Doctor-diagnosed asthma 3. Prescribed MDI inhalers 4. Asthma severity BTS level 3 or below.

You may qualify if:

• Age 5 to 15 years 11 months
• Doctor-diagnosed asthma
• Prescribed MDI inhalers
• Asthma severity BTS level 3 or below.

You may not qualify if:

• Non-English speaking families
• Prescribed dry powder inhaler devices
• Admission with acute asthma in the last 3 months

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

Study Sites (1)

Clinical Research Facility, Sheffield Childrens Hospital

Sheffield, 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: August 2, 2023
• Study Start: July 16, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 2, 2023

Record last verified: 2019-12

Locations

GB (1)