Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS) (OASIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Asthma; Asthma Attack; Asthma Persistent
• Intervention / Treatment: Device: ReferID

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Guys and St Thomas NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Review and feedback of the ReferID Tool	Acceptability of using the ReferID tool by completion of questionnaire, with users providing feedback using a likert scale, with 1 = poor, 5 = excellent.	12 months

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London; AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; COVID-19; Asthma
• Other Study ID Numbers: 274450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No