AsthmaNCT02140671
Launching an Asthma Initiative Designed to Improve Asthma Management and Outcomes
An observational study of Asthma, run by Research in Real-Life Ltd.
Trial summary
Following on from a 10 year study conducted in Finland this study is designed to test the validity and sustainability of an enhanced asthma management model for the UK. Read more about this study
- Who is it for?
- Ages 3 to 65 years
- Conditions the study is for
- Asthma
- How many people
- 33,370 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Aug 2015
- Phase
- Observational
- 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 3 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patient questionnaire will be subject to local refinement in line with local needs, targets and priorities but will assess - * Asthma Control e.g. ACT, or ACQ or RCP3 * Lifestyle - i.e. smoking status * Comorbidities * Patient perceived adherence * Side effects The practice and patient reports will be used to characterise the patient in terms of risk and control. They will give a complete picture of the patient's asthma and will be used to identify patients for diagnostic assessment, medical management and education. Patients will then be stratified into Group 1 (patients with asthma) or Group 2 (Patients identified for further diagnostic assessment and/or with diagnostic doubt).
Who may be able to join
- Motivated and driven local champions in the area
- High rates of hospital admissions (aged 3-65)
- High asthma prevalence
- High percentage of patients who have had an asthma review in the previous 15 months.
Who cannot join
- -
About this study
Official title: To Deliver a Pilot Project on Effective Interventions to Ensure: Diagnostic Accuracy, Management of Risk and Control and Self-management for Asthma Patients.
Following on from a 10 year study conducted in Finland this study is designed to test the validity and sustainability of an enhanced asthma management model for the UK.
Read the detailed description
The British Lung Foundation (BLF) aims to work with the governments in the four UK nations to launch an asthma initiative designed to improve asthma management and outcomes. The project incorporates key learning from a 10 year programme in Finland designed to improve asthma care and cap healthcare costs for paediatric and adult populations.
The Finland programme focused on accurate diagnosis, training and education of healthcare professionals and patients and early use of anti-inflammatory therapy. The programme successfully improved medication compliance, reduced asthma hospital admissions, reduced asthma-related benefit claims and reduced the overall cost of asthma to the Finnish Government.
To test the validity and sustainability of an enhanced asthma management model for the UK, the BLF proposes to undertake a pilot initiative in England. The pilot will focus on: improving diagnostic accuracy through analysis of GP asthma registers; increasing asthma education among healthcare professionals; assessment of risk and control of patient's asthma; supportive self-management and education of people with asthma.
It is anticipated that the pilot will lead to measureable and significant improvements in asthma management, including:
- Reduced number of severe exacerbations (asthma hospitalisation, A\&E attendance and oral steroid rescue)
- Improved diagnostic accuracy (and reduction of diagnostic doubt)
- Improved implementation of recognised asthma guidelines, including appropriate step wise management of patients
The pilot will also aim to increase the proportion of patients on the asthma register with an asthma management plan and a recorded asthma control test therefore supporting higher levels of control, and will promote peer-to-peer health care professional asthma education and knowledge sharing to establish an asthma-training legacy.
The pilot model will be sustainable and reproducible across England and the devolved nations (Scotland, Wales and Northern Ireland). Whilst the core aspects of an agreed national model will be rolled out across the pilot site, it will be tailored and refined through local collaboration (primary care, secondary care and commissioners) to help attain local targets in line with regional differences, needs and priorities.
Results from the pilot will be reported 15 months after project initiation on site (July/August 2014)
- Conditions
- Asthma
- Keywords
- asthma management, anti-inflammatory therapy, compliance, hospital admission, educations, self-management, guidelines, exacerbations, diagnostic accuracy, symptom control
- Medical subject headings
- Asthma, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with an asthma diagnosis | Not described | |
| Patients where there is diagnostic doubt | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbations reduction
An exacerbation is defined (in line with the European Respiratory Society/American Thoracic Society guidelines) as: acute oral steroids, out of hours or Accident and Emergency (A\&E) attendance for asthma, or hospitalisation for asthma.
Rationale for selecting exacerbations as the primary outcome:
- They are the time of greatest risk to patients and greatest resource use
- Exacerbations are defined by routinely held data, such as drug prescriptions (oral steroids and out of hours and A\&E attendance), hence are reliable when captured in primary care
- Exacerbations reflect current control and future risk; a reduction in exacerbations indicates an improvement in asthmatic inflammation control and improved use of anti-inflammatory therapy
Measured: 1 year
Secondary outcomes (5)
1. Increased assessment of patients with equivocal diagnoses and reduction of diagnostic doubt (also detailed under process outcomes)
Measured: 1 year
2. Hospitalisations ¬- number and rate - coded for: • Asthma • Lower respiratory conditions (including asthma), i.e. "asthma-related" events
Measured: 1 year
3. Inhaled corticosteroids adherence
Measured: 1 year
4. Referral rate of high-risk patients to local specialist
Measured: 1 year
5. British Asthma Guideline adherence: appropriate step-wise management of patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startMay 2012
- Primary completionAug 2014 (estimated)
- Study completionAug 2015 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33,370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research in Real-Life Ltd
- Sponsor type
- Research network
- Collaborators
- British Lung Foundation
- Responsible party
- Sponsor
- Investigators
- David Price, Principal investigator, Reasearch in Real Life Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140671
- Sponsor's protocol ID
- ORO3112
- Status last verified
- May 2014
- First submitted
- 14 May 2014
- Last updated
- 16 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Deliver a Pilot Project on Effective Interventions to Ensure: Diagnostic Accuracy, Management of Risk and Control and Self-management for Asthma Patients.
- ClinicalTrials.gov ID
- NCT02140671
- Acronym / sponsor ID
- ORO3112
- Conditions
- Asthma
- Keywords
- asthma management, anti-inflammatory therapy, compliance, hospital admission, educations, self-management, guidelines, exacerbations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 33,370 participants (estimated)
- Lead sponsor
- Research in Real-Life LtdResearch network
- Collaborators
- British Lung Foundation
- Study start
- May 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 16 May 2014 (estimated)
- 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.
Following on from a 10 year study conducted in Finland this study is designed to test the validity and sustainability of an enhanced asthma management model for the UK.
Detailed description
The British Lung Foundation (BLF) aims to work with the governments in the four UK nations to launch an asthma initiative designed to improve asthma management and outcomes. The project incorporates key learning from a 10 year programme in Finland designed to improve asthma care and cap healthcare costs for paediatric and adult populations.
The Finland programme focused on accurate diagnosis, training and education of healthcare professionals and patients and early use of anti-inflammatory therapy. The programme successfully improved medication compliance, reduced asthma hospital admissions, reduced asthma-related benefit claims and reduced the overall cost of asthma to the Finnish Government.
To test the validity and sustainability of an enhanced asthma management model for the UK, the BLF proposes to undertake a pilot initiative in England. The pilot will focus on: improving diagnostic accuracy through analysis of GP asthma registers; increasing asthma education among healthcare professionals; assessment of risk and control of patient's asthma; supportive self-management and education of people with asthma.
It is anticipated that the pilot will lead to measureable and significant improvements in asthma management, including:
- Reduced number of severe exacerbations (asthma hospitalisation, A\&E attendance and oral steroid rescue)
- Improved diagnostic accuracy (and reduction of diagnostic doubt)
- Improved implementation of recognised asthma guidelines, including appropriate step wise management of patients
The pilot will also aim to increase the proportion of patients on the asthma register with an asthma management plan and a recorded asthma control test therefore supporting higher levels of control, and will promote peer-to-peer health care professional asthma education and knowledge sharing to establish an asthma-training legacy.
The pilot model will be sustainable and reproducible across England and the devolved nations (Scotland, Wales and Northern Ireland). Whilst the core aspects of an agreed national model will be rolled out across the pilot site, it will be tailored and refined through local collaboration (primary care, secondary care and commissioners) to help attain local targets in line with regional differences, needs and priorities.
Results from the pilot will be reported 15 months after project initiation on site (July/August 2014)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with an asthma diagnosis | – | – |
| Patients where there is diagnostic doubt | – | – |
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patient questionnaire will be subject to local refinement in line with local needs, targets and priorities but will assess - * Asthma Control e.g. ACT, or ACQ or RCP3 * Lifestyle - i.e. smoking status * Comorbidities * Patient perceived adherence * Side effects The practice and patient reports will be used to characterise the patient in terms of risk and control. They will give a complete picture of the patient's asthma and will be used to identify patients for diagnostic assessment, medical management and education. Patients will then be stratified into Group 1 (patients with asthma) or Group 2 (Patients identified for further diagnostic assessment and/or with diagnostic doubt).
Key inclusion criteria (4 listed)
- Motivated and driven local champions in the area
- High rates of hospital admissions (aged 3-65)
- High asthma prevalence
- High percentage of patients who have had an asthma review in the previous 15 months.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exacerbations reduction
Time frame: 1 year
An exacerbation is defined (in line with the European Respiratory Society/American Thoracic Society guidelines) as: acute oral steroids, out of hours or Accident and Emergency (A\&E) attendance for asthma, or hospitalisation for asthma. Rationale for selecting exacerbations as the primary outcome: * They are the time of greatest risk to patients and greatest resource use * Exacerbations are defined by routinely held data, such as drug prescriptions (oral steroids and out of hours and A\&E attendance), hence are reliable when captured in primary care * Exacerbations reflect current control and future risk; a reduction in exacerbations indicates an improvement in asthmatic inflammation control and improved use of anti-inflammatory therapy
5 secondary outcomes
1. Increased assessment of patients with equivocal diagnoses and reduction of diagnostic doubt (also detailed under process outcomes)
Time frame: 1 year
2. Hospitalisations ¬- number and rate - coded for: • Asthma • Lower respiratory conditions (including asthma), i.e. "asthma-related" events
Time frame: 1 year
3. Inhaled corticosteroids adherence
Time frame: 1 year
4. Referral rate of high-risk patients to local specialist
Time frame: 1 year
5. British Asthma Guideline adherence: appropriate step-wise management of patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
David Price principal investigator
Reasearch in Real Life Ltd
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Research in Real-Life Ltd.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Exacerbations reduction (time frame: 1 year). 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 16 May 2014.