Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS)

Not Applicable

Completed

• Conditions: Asthma; Asthma Attack; Asthma Persistent; Covid19
• Interventions: Device: ReferID

• Registration Number: NCT04941001
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-18
• Study First Posted: 2021-06-28
• Study Start: 2021-08-09
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthcare professional using ReferID Tool in primary care	ReferID	The asthma review will be undertaken by a healthcare professional with the use of the ReferID tool in primary care

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
Inhaler technique assessed.	12 months	Proportion of subjects invited to have a review and found to have suboptimal inhaler technique.
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).
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.
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.
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

Trial Locations

Locations (1)

Guys and St Thomas NHS Foundation Trust; 🇬🇧 London, United Kingdom