Launching an Asthma Initiative Designed to Improve Asthma Management and Outcomes

May 14, 2014 updated by: Research in Real-Life Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33370

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients with an asthma diagnosis
Patients where there is diagnostic doubt

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
1. Increased assessment of patients with equivocal diagnoses and reduction of diagnostic doubt (also detailed under process outcomes)
Time Frame: 1 year
1 year
2. Hospitalisations ¬- number and rate - coded for: • Asthma • Lower respiratory conditions (including asthma), i.e. "asthma-related" events
Time Frame: 1 year
1 year
3. Inhaled corticosteroids adherence
Time Frame: 1 year
1 year
4. Referral rate of high-risk patients to local specialist
Time Frame: 1 year
1 year
5. British Asthma Guideline adherence: appropriate step-wise management of patients
Time Frame: 1 year
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
1. Accident and Emergency (A&E) attendance
Time Frame: 1 year
1 year
2. Proportion of patients on each asthma register that have a confirmed asthma diagnosis
Time Frame: 1 year
1 year
3. Proportion of patients with an asthma management plan
Time Frame: 1 year
1 year
4. Proportion of patients with a recorded asthma control test (ACT) and Royal College of Physician three questions (RCP3)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Research in Real-Life Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
British Lung Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Price, Reasearch in Real Life Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ORO3112

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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