Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS)

Study Overview
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Brief Summary
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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.

Official Title
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Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS) in Primary Care Using a Digital Consultation Tool During the COVID-19 Pandemic

Conditions
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Asthma, Asthma Attack, Asthma Persistent, Covid19

Intervention / Treatment
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* Device: ReferID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthcare professional using ReferID Tool in primary care<br>The asthma review will be undertaken by a healthcare professional with the use of the ReferID tool in primary care | Device: ReferID<br>* The ReferID tool is a digital tool which can be used to facilitate a review of asthma in primary care<br>|
| No Intervention: Usual care in primary care<br>A cohort of patients will be recruited who continue to receive usual care in primary care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of exacerbation frequency | 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control measured by the Asthma Control Questionnaire (ACQ) - 6. | 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. | 12 months | 
| Salbutamol use (measured by the number of inhalers issued) | Change in primary care salbutamol prescription refill frequency 12 months before and 12 months after initial consultation. | 24 months | 
| Emergency care utilisation | Frequency of emergency department and/or hospital admission due to acute asthma 12 months before and 12 months after initial consultation. | 24 months | 
| Quality of Life Score measured by the mini Asthma Quality of Life Questionnaire (mAQLQ) | 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. | 12 months | 
| Adherence to inhaled corticosteroids | 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). | 24 months | 
| Inhaler technique assessed. | Proportion of subjects invited to have a review and found to have suboptimal inhaler technique. | 12 months | 
| Number of patients referred to secondary care who are taking part in the study. | Proportion of subjects referred to secondary care for further assessment of suspected severe asthma or work-related asthma | 12 months | 
| Number of patients initiated on biologic therapy | Proportion of subjects referred to secondary care with confirmed severe asthma initiated on biologic therapies | 12 months | 
| Number of patients who are found to have an incorrect diagnosis. | Proportion of subjects in whom the diagnosis of asthma is found to be incorrect | 12 months |