Asthma, Asthma Attack, Asthma Persistent, Covid19
Conditions
Brief summary
A digital tool, called ReferID has been developed to facilitate the review of asthma patients. It aims to assist in the identification of patients with uncontrolled and/or severe asthma and to ensure a timely referral to secondary care where appropriate. To validate the tool, patients will be randomised to have a review with a healthcare professional using tool to facilitate the review or to continue receiving usual care. Outcome measures including exacerbation frequency and level of asthma control will be assessed at 12 months.
Interventions
DEVICEReferID
The ReferID tool is a digital tool which can be used to facilitate a review of asthma in primary care
Sponsors
AstraZeneca
King's College London
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Masking description
An electronic randomisation programme will be used to assign the patient to each arm of the study in primary care. However during the review, masking will not be possible.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* All asthma patients with 1 of more exacerbations in the last 12 months or receiving high dose inhaled corticosteroids. * Patients able and willing to provide informed consent. * Patients aged 18 and over.
Exclusion criteria
* Patients who lack capacity. * Patients who do not have a diagnosis of asthma * Patients who are unable to provide informed consent * Patients under the age of 18 * Patients already under a severe asthma centre
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of exacerbation frequency | 24 months | Measured by the number of courses of oral corticosteroids measured at 12 months before and 12 months after initial consultation. Exacerbations are defined as the need for oral corticosteroids prescribed by a healthcare professional for a minimum of 3 consecutive days in the context of worsening asthma symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma control measured by the Asthma Control Questionnaire (ACQ) - 6. | 12 months | Asthma control questionnaire completed on day 1 and at 12 months after initial consultation. Total score ranges from 0-6, with 0 = no impairment due to asthma, 6 = maximum impairment due to asthma. |
| Salbutamol use (measured by the number of inhalers issued) | 24 months | Change in primary care salbutamol prescription refill frequency 12 months before and 12 months after initial consultation. |
| Emergency care utilisation | 24 months | Frequency of emergency department and/or hospital admission due to acute asthma 12 months before and 12 months after initial consultation. |
| Quality of Life Score measured by the mini Asthma Quality of Life Questionnaire (mAQLQ) | 12 months | Change in quality of life score at day 1 and at 12 months (mAQLQ). Score for each question ranges from 0-7, with 0 = totally limited, 7 = not limited at all. The score is calculated as an average for each domain, with a clinically minimum difference of 0.5. |
| Inhaler technique assessed. | 12 months | Proportion of subjects invited to have a review and found to have suboptimal inhaler technique. |
| Number of patients referred to secondary care who are taking part in the study. | 12 months | Proportion of subjects referred to secondary care for further assessment of suspected severe asthma or work-related asthma |
| Number of patients initiated on biologic therapy | 12 months | Proportion of subjects referred to secondary care with confirmed severe asthma initiated on biologic therapies |
| Number of patients who are found to have an incorrect diagnosis. | 12 months | Proportion of subjects in whom the diagnosis of asthma is found to be incorrect |
| Adherence to inhaled corticosteroids | 24 months | Adherence to inhaled corticosteroids 12 months before and 12 months after initial consultation (measured as a percentage of the number of doses of inhaled corticosteroids issued/the expected number of doses in 12months). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Review and feedback of the ReferID Tool | 12 months | Acceptability of using the ReferID tool by completion of questionnaire, with users providing feedback using a likert scale, with 1 = poor, 5 = excellent. |
Countries
United Kingdom
Outcome results
None listed