Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS)

NCT04941001 | Completed

• 1 other identifier: 274450
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Asthma Attack; Asthma Persistent; Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Asthma control measured by the Asthma Control Questionnaire (ACQ) - 6.

  12 months

• Salbutamol use (measured by the number of inhalers issued)

  24 months

• Emergency care utilisation

  24 months

• Quality of Life Score measured by the mini Asthma Quality of Life Questionnaire (mAQLQ)

  12 months

• Adherence to inhaled corticosteroids

  24 months

Other Outcomes (1)

• Review and feedback of the ReferID Tool

  12 months

Study Arms (2)

Healthcare professional using ReferID Tool in primary care

ACTIVE COMPARATOR

The asthma review will be undertaken by a healthcare professional with the use of the ReferID tool in primary care

Device: ReferID

Usual care in primary care

NO INTERVENTION

A cohort of patients will be recruited who continue to receive usual care in primary care

Interventions

ReferID DEVICE

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

Healthcare professional using ReferID Tool in primary care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• AstraZeneca: collaborator
• King's College London: collaborator

Study Sites (1)

Guys and St Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Asthma; COVID-19

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 28, 2021
• Study Start: August 9, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)