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The Use of Home-monitoring and mHealth Systems to Predict Asthma Control and the Occurrence of Asthma Exacerbations

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ClinicalTrials.gov Identifier: NCT02774772
Recruitment Status : Completed
First Posted : May 17, 2016
Last Update Posted : February 7, 2019
Sponsor:
Collaborators:
University of Manchester
Imperial College London
Leiden University Medical Center
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

Brief Summary:
The investigators will collect a range of physiological, behavioural and environmental data using current mHealth and home-monitoring systems, environmental databases and patient characteristics, to determine to what extent asthma control and the occurrence of asthma exacerbations can be predicted.

Condition or disease
Asthma

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Home-monitoring and mHealth Systems to Predict Asthma Control and the Occurrence of Asthma Exacerbations
Study Start Date : April 2016
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma




Primary Outcome Measures :
  1. Asthma control using the asthma control diary [ Time Frame: After 1 month ]
    A score of 0.0-0.75 is classified as well-controlled asthma; 0.75-1.5 as a partly controlled; and >1.5 as poorly controlled asthma.

  2. Severe asthma exacerbations [ Time Frame: 1 year & preliminary analysis after 1 month ]

    Severe asthma exacerbations are events that require urgent action on the part of the patient and physician to prevent a serious outcome, such as hospitalization or death from asthma. The occurrence of severe asthma exacerbations is an important marker of poor asthma control. Severe asthma exacerbations are defined by the occurrence of at least one of the following:

    • Use of systemic corticosteroids (tablets, suspension, or injection), or an increase from a stable maintenance dose, for at least 3 days. For consistency, courses of corticosteroids separated by 1 week or more should be treated as separate severe exacerbations.
    • A hospitalisation or ER visit because of asthma, requiring systemic corticosteroids.

  3. Moderate asthma exacerbations [ Time Frame: 1 year & preliminary analysis after 1 month ]

    A moderate asthma exacerbation is an event that, when recognized, should result in a temporary change in treatment, in an effort to prevent the exacerbation from becoming severe. Moderate asthma exacerbations are defined by occurrence of at least one or more of the following:

    • deterioration in symptoms,
    • deterioration in lung function,
    • and increased rescue bronchodilator use. These features should last for 2 days or more, but not be severe enough to warrant systemic corticosteroid use and/or hospitalization. ER visits for asthma (e.g., for routine sick care), not requiring systemic corticosteroids, are also classified as moderate exacerbations


Secondary Outcome Measures :
  1. User acceptence [ Time Frame: 1 year & preliminary analysis after 1 month ]
    User acceptance of each mHealth and home-monitoring system, as determined by user-adherence and the After-Scenario Questionnaire feedback (ASQ)

  2. Asthma Control using asthma control questionnaire [ Time Frame: 1 year ]
    A score of 0.0-0.75 is classified as well-controlled asthma; 0.75-1.5 as a partly controlled; and >1.5 as poorly controlled asthma.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
One hundred and fifty patients with asthma will be recruited from outpatient clinics and from general practices in London, Manchester (United Kingdom) and Leiden (Netherlands).
Criteria

Inclusion Criteria:

  1. Doctors-diagnosis of asthma with confirmation of asthma from one or more of the following tests in medical notes:

    i) Reversibility of 12% and 200ml in a spirometry following administration of a bronchodilator medication ii) Peak flow monitoring for one week iii) Positive bronchial challenge

  2. BTS asthma treatment step 2-4, for a minimum of 6 months in the previous year
  3. A course of oral prednisone for a minimum of three days, or an emergency department visit/hospitalisation for asthma, in the previous twelve months. Or currently experiencing uncontrolled asthma (based on the result of the Asthma Control Questionnaire)

Exclusion Criteria:

  1. Comorbidities that cause overlapping symptoms such as breathlessness, wheeze, cough or other interfering chronic condition (for example other symptomatic chronic respiratory disease, cardiac failure etc.).
  2. Unable to understand English or Dutch, as appropriate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774772


Locations
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United Kingdom
University Hospital of South Manchester
Manchester, United Kingdom, m23 9lt
Sponsors and Collaborators
Manchester University NHS Foundation Trust
University of Manchester
Imperial College London
Leiden University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02774772    
Other Study ID Numbers: 15/NW/0845
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases