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

NCT02774772 | Completed

• 1 other identifier: 15/NW/0845
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

• Asthma control using the asthma control diary

  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.

  After 1 month

• Severe asthma exacerbations

  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.

  1 year & preliminary analysis after 1 month

• Moderate asthma exacerbations

  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

  1 year & preliminary analysis after 1 month

Secondary Outcomes (2)

• User acceptence

  1 year & preliminary analysis after 1 month

• Asthma Control using asthma control questionnaire

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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
• BTS asthma treatment step 2-4, for a minimum of 6 months in the previous year
• 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)

You may not qualify if:

• 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.).
• Unable to understand English or Dutch, as appropriate

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• University of Manchester: collaborator
• Imperial College London: collaborator
• Leiden University Medical Center: collaborator

Study Sites (1)

University Hospital of South Manchester

Manchester, m23 9lt, United Kingdom

Location

Related Publications (2)

• Khusial RJ, Sont JK, Usmani OS, Bonini M, Chung KF, Fowler SJ, Honkoop PJ. The Effect of Inhaled Beta-2 Agonists on Heart Rate in Patients With Asthma: Sensor-Based Observational Study. JMIR Cardio. 2024 Dec 11;8:e56848. doi: 10.2196/56848.

  PMID: 39661964 DERIVED

• Honkoop PJ, Simpson A, Bonini M, Snoeck-Stroband JB, Meah S, Fan Chung K, Usmani OS, Fowler S, Sont JK. MyAirCoach: the use of home-monitoring and mHealth systems to predict deterioration in asthma control and the occurrence of asthma exacerbations; study protocol of an observational study. BMJ Open. 2017 Jan 24;7(1):e013935. doi: 10.1136/bmjopen-2016-013935.

  PMID: 28119390 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: May 17, 2016
• Study Start: April 1, 2016
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: February 7, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)