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

Primary Purpose

Asthma, Asthma Attack, Asthma Persistent

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ReferID
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Guys and St Thomas NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Healthcare professional using ReferID Tool in primary care

Usual care in primary care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Emergency care utilisation
Frequency of emergency department and/or hospital admission due to acute asthma 12 months before and 12 months after initial consultation.
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.
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).
Inhaler technique assessed.
Proportion of subjects invited to have a review and found to have suboptimal inhaler technique.
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
Number of patients initiated on biologic therapy
Proportion of subjects referred to secondary care with confirmed severe asthma initiated on biologic therapies
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

Full Information

First Posted
June 3, 2021
Last Updated
August 25, 2023
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
AstraZeneca, King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT04941001
Brief Title
Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 9, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
AstraZeneca, King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Asthma Attack, Asthma Persistent, Covid19

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
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.
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthcare professional using ReferID Tool in primary care
Arm Type
Active Comparator
Arm Description
The asthma review will be undertaken by a healthcare professional with the use of the ReferID tool in primary care
Arm Title
Usual care in primary care
Arm Type
No Intervention
Arm Description
A cohort of patients will be recruited who continue to receive usual care in primary care
Intervention Type
Device
Intervention Name(s)
ReferID
Intervention Description
The ReferID tool is a digital tool which can be used to facilitate a review of asthma in primary care
Primary Outcome Measure Information:
Title
Rate of exacerbation frequency
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Asthma control measured by the Asthma Control Questionnaire (ACQ) - 6.
Description
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.
Time Frame
12 months
Title
Salbutamol use (measured by the number of inhalers issued)
Description
Change in primary care salbutamol prescription refill frequency 12 months before and 12 months after initial consultation.
Time Frame
24 months
Title
Emergency care utilisation
Description
Frequency of emergency department and/or hospital admission due to acute asthma 12 months before and 12 months after initial consultation.
Time Frame
24 months
Title
Quality of Life Score measured by the mini Asthma Quality of Life Questionnaire (mAQLQ)
Description
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.
Time Frame
12 months
Title
Adherence to inhaled corticosteroids
Description
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).
Time Frame
24 months
Title
Inhaler technique assessed.
Description
Proportion of subjects invited to have a review and found to have suboptimal inhaler technique.
Time Frame
12 months
Title
Number of patients referred to secondary care who are taking part in the study.
Description
Proportion of subjects referred to secondary care for further assessment of suspected severe asthma or work-related asthma
Time Frame
12 months
Title
Number of patients initiated on biologic therapy
Description
Proportion of subjects referred to secondary care with confirmed severe asthma initiated on biologic therapies
Time Frame
12 months
Title
Number of patients who are found to have an incorrect diagnosis.
Description
Proportion of subjects in whom the diagnosis of asthma is found to be incorrect
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Review and feedback of the ReferID Tool
Description
Acceptability of using the ReferID tool by completion of questionnaire, with users providing feedback using a likert scale, with 1 = poor, 5 = excellent.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Guys and St Thomas NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS)

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