Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05972226 |
Other study ID # |
SCH-2238 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 16, 2018 |
Est. completion date |
December 31, 2019 |
Study information
Verified date |
December 2019 |
Source |
Sheffield Children's NHS Foundation Trust |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
Asthma is a long-term condition in children, often managed in primary care but around 20%
children with asthma require secondary or tertiary level treatment and care by experienced
respiratory paediatricians and nurses. The positive effects of treatment with inhaler and
anti-inflammatory medications for childhood asthma are well-documented however, less than 50%
children take their medications regularly as prescribed. Asthma deaths in children are rare
but the national review of asthma deaths in the UK between 2012 and 2013 concluded that two
thirds of the asthma deaths were preventable and that poor adherence to therapy was found to
be a preventable cause in 34%.
It is known that educational interventions and use of written action plans improve asthma
control. However, two thirds of patients do not attend their asthma review. Lack of adherence
to medications is a global problem with £300million worth of medications /yr wasted in
primary care due to poor adherence and 50% patients not taking medication as prescribed. With
the UK facing an increasingly unmanageable demand on healthcare services, this morbidity and
cost needs to be addressed.
So, why do people with asthma omit their medications? Clinicians have developed a conceptual
framework to enable clinicians to understand the barriers to medication adherence. Habit
formation is underpinned by a complex interaction of feedback, problem solving, prompts and
implementation plans. The interaction between motivation (reasons that people "won't" take
medication, such as illness perceptions, medication beliefs and contrivance) and capability
opportunity (reasons that people "can't" take medication, such as forgetting, being too busy,
having trouble incorporating into the routine) needs to be understood and addressed in order
to change and sustain habit formation.
Adherence monitoring methods have been studied at length in patients with asthma, ranging
from non-judgemental questioning by a clinician, which is cheap and easy to do in clinic, but
vastly overestimates adherence, to self-report questionnaires and diary cards to prescription
refill data and drug assays. These methods are increasingly objective, but remain subject to
inaccuracies due to susceptibility to dose "dumping" and impracticalities. The most objective
method of adherence monitoring is the use of electronic monitoring devices (EMDs) which can
provide continuous monitoring and "smart" features such as transmission of data to electronic
devices. The "STAAR" (Study of Asthma Adherence Reminders) study used adherence monitoring
with feedback to target both motivation and capability opportunity with an
educational/behavioural intervention and a practical adherence facilitator with reminder
alarms chosen from a range of alarms by the child. Although a significant improvement in
adherence from 49% to 70% was noted in the intervention group, there was no significant
improvement in ACQ, the primary outcome measure. There was, however, a significantly lower
number of exacerbations in the intervention group, measured by number of hospital and GP
visits, number of courses of oral steroids and number of days missed from school.
There is a growing number of digital solutions for asthma Self-Care, with many of these
produced by pharmaceutical companies as companion products or research tools. In addition, an
increasing number of HealthApps and remote monitoring self-management software platforms are
appearing on the commercial market. There are challenges to overcome before these can be
implemented in paediatric clinical practice as all are adult based, are of variable quality,
and more research is needed to refine the technology and links to electronic health records.
However, smart inhalers and HealthApps in a digitally evolving NHS have the potential to
support self-management of long-term conditions such as asthma at scale, to support digital
transformation of health services to risk stratify according to need and to provide a
personalised approach to care, thereby reducing emergency admissions and improving patient
safety and quality of life.
Asthma + me, will be a comprehensive CE-marked technology-enabled self-care solution for
children and young people with asthma and their parents has been developed by Aseptika Ltd,
in consultation with Sheffield Children's Hospital, to support children with asthma to
implement a new intermediate care pathway bridging the transition from hospital outpatient
services back to primary care. It is specifically designed to meet the needs of children aged
5-18yrs and has two versions within the same App; a child-friendly view and a parent/carer
view making it different from the many adult asthma management Apps available. It also
supports integrated devices, medication diaries, trigger alerts and symptom scores. Core to
Asthma +me is education, engagement and empowerment for children /young people and their
parents. It has an in-built syllabus supported with an intensive half-day family training
session to upskill those newly diagnosed.
Asthma + me supports a universal metered-dose inhaler tracker that connects wirelessly to the
Asthma +me App counting inhaler doses, providing reminders to take the next dose and acting
as an activity tracker for children too young or unable to wear an activity tracker at
school. Patient-generated data will be used to incentivise adherence through a novel
motivating rewards system.
A PDF report will be sent automatically from Asthma +me to the electronic patient record at
Sheffield Children's Hospital. The consultant paediatrician or asthma nurse can remotely
review progress or can access the patient-generated data in the event of an emergency
consultation. Uniquely, as the child or their parent enters their data, their asthma action
plan is automatically populated, viewed on the smart phone, printed and emailed as an
integral part of the weekly report.
In this project, 15 children (and their families) will trial Asthma + me with PUFFClicker and
4 hour education session and report what worked and what didn't. The investigators will
assess their views using structured Interviews and questionnaires and the investigators will
look at any changes in their asthma symptoms. The investigators will also map patient
pathways and collect health economics data to project costs and 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.