AsthmaOASISNCT04941001
Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS)
A study testing ReferID in people with Asthma and Asthma Attack, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Asthma Attack, Asthma Persistent
- What is being tested?
- ReferID
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Aug 2021to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guys and St Thomas NHS Foundation Trust
London, SE1 9RT
About this study
Official title: 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.
- Conditions
- Asthma, Asthma Attack, Asthma Persistent, Covid19
- Being tested
- ReferID
- Medical subject headings
- Asthma, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReferIDDevice
The ReferID tool is a digital tool which can be used to facilitate a review of asthma in primary care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 24 months
Inhaler technique assessed.
Proportion of subjects invited to have a review and found to have suboptimal inhaler technique.
Measured: 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
Measured: 12 months
Number of patients initiated on biologic therapy
Proportion of subjects referred to secondary care with confirmed severe asthma initiated on biologic therapies
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start9 Aug 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941001
- Sponsor's protocol ID
- 274450
- Acronym
- OASIS
- Status last verified
- Jul 2023
- First submitted
- 3 Jun 2021
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS) in Primary Care Using a Digital Consultation Tool During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04941001
- Acronym / sponsor ID
- OASIS / 274450
- Conditions
- Asthma, Asthma Attack, Asthma Persistent, Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- AstraZeneca, King's College London
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare professional using ReferID Tool in primary care | Active comparator | Device: ReferIDThe asthma review will be undertaken by a healthcare professional with the use of the ReferID tool in primary care |
| Usual care in primary care | No intervention | –A cohort of patients will be recruited who continue to receive usual care in primary care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReferIDThe ReferID tool is a digital tool which can be used to facilitate a review of asthma in primary care | Device | Healthcare professional using ReferID Tool in primary care |
Primary outcome
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.
9 secondary outcomes
Asthma control measured by the Asthma Control Questionnaire (ACQ) - 6.
Time frame: 12 months
Salbutamol use (measured by the number of inhalers issued)
Time frame: 24 months
Emergency care utilisation
Time frame: 24 months
Quality of Life Score measured by the mini Asthma Quality of Life Questionnaire (mAQLQ)
Time frame: 12 months
Adherence to inhaled corticosteroids
Time frame: 24 months
Inhaler technique assessed.
Time frame: 12 months
Number of patients referred to secondary care who are taking part in the study.
Time frame: 12 months
Number of patients initiated on biologic therapy
Time frame: 12 months
Number of patients who are found to have an incorrect diagnosis.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReferID in people with Asthma and Asthma Attack, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of exacerbation frequency (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.