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OpenTrials
Completed

NCT Number: NCT04941001

Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS)

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.

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Key information

Conditions

Asthma Asthma Attack Asthma Persistent Bronchial Diseases COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guys and St Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ReferID

Device

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

Primary outcomes

  1. Rate of exacerbation frequency

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Salbutamol use (measured by the number of inhalers issued)

    Time frame: 24 months

    Change in primary care salbutamol prescription refill frequency 12 months before and 12 months after initial consultation.

  3. Emergency care utilisation

    Time frame: 24 months

    Frequency of emergency department and/or hospital admission due to acute asthma 12 months before and 12 months after initial consultation.

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

    Time frame: 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.

  5. Adherence to inhaled corticosteroids

    Time frame: 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).

  6. Inhaler technique assessed.

    Time frame: 12 months

    Proportion of subjects invited to have a review and found to have suboptimal inhaler technique.

  7. Number of patients referred to secondary care who are taking part in the study.

    Time frame: 12 months

    Proportion of subjects referred to secondary care for further assessment of suspected severe asthma or work-related asthma

  8. Number of patients initiated on biologic therapy

    Time frame: 12 months

    Proportion of subjects referred to secondary care with confirmed severe asthma initiated on biologic therapies

  9. Number of patients who are found to have an incorrect diagnosis.

    Time frame: 12 months

    Proportion of subjects in whom the diagnosis of asthma is found to be incorrect

Other outcomes

  1. Review and feedback of the ReferID Tool

    Time frame: 12 months

    Acceptability of using the ReferID tool by completion of questionnaire, with users providing feedback using a likert scale, with 1 = poor, 5 = excellent.

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • AstraZeneca
  • King's College London

Registry information

Official study title

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

Acronym: OASIS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2021
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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