NCT02140671

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33,370

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

2.3 years

First QC Date

May 14, 2014

Last Update Submit

May 14, 2014

Conditions

Keywords

asthma managementanti-inflammatory therapycompliancehospital admissioneducationsself-managementguidelinesexacerbationsdiagnostic accuracysymptom control

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (5)

  • 1. Increased assessment of patients with equivocal diagnoses and reduction of diagnostic doubt (also detailed under process outcomes)

    1 year

  • 2. Hospitalisations ¬- number and rate - coded for: • Asthma • Lower respiratory conditions (including asthma), i.e. "asthma-related" events

    1 year

  • 3. Inhaled corticosteroids adherence

    1 year

  • 4. Referral rate of high-risk patients to local specialist

    1 year

  • 5. British Asthma Guideline adherence: appropriate step-wise management of patients

    1 year

Other Outcomes (4)

  • 1. Accident and Emergency (A&E) attendance

    1 year

  • 2. Proportion of patients on each asthma register that have a confirmed asthma diagnosis

    1 year

  • 3. Proportion of patients with an asthma management plan

    1 year

  • +1 more other outcomes

Study Arms (2)

Patients with an asthma diagnosis

Patients where there is diagnostic doubt

Eligibility Criteria

Age3 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

AsthmaPatient Compliance

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • David Price

    Reasearch in Real Life Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 16, 2014

Study Start

May 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2015

Last Updated

May 16, 2014

Record last verified: 2014-05