Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS)

Asthma Clinical Trial

— OASIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04941001
• Other study ID #: 274450
• Status: Completed
• Phase: N/A
• Start date: August 9, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: July 2023
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma Attack
• Asthma Persistent
• COVID-19
• Covid19

Intervention

Device:
• ReferID
The ReferID tool is a digital tool which can be used to facilitate a review of asthma in primary care

Locations

Country	Name	City	State
United Kingdom	Guys and St Thomas NHS Foundation Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	AstraZeneca, King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Inhaler technique assessed.	Proportion of subjects invited to have a review and found to have suboptimal inhaler technique.	12 months
Secondary	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
Secondary	Number of patients initiated on biologic therapy	Proportion of subjects referred to secondary care with confirmed severe asthma initiated on biologic therapies	12 months
Secondary	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