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| Name | Class |
|---|---|
| University of Manchester | OTHER |
| Imperial College London | OTHER |
| Leiden University Medical Center | OTHER |
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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.
This observational study occurs alongside participants' normal asthma care. Participants will be asked to attend their normal GP and hospital appointments, and to continue to take their medication as determined by their usual healthcare team.
In addition to their normal care, participants will attend an induction visit and complete a 12-month home-monitoring period with 2 phases:
Phase 1: one-month period of daily monitoring of asthma
Phase 2: eleven-month period of weekly monitoring of asthma. Patients will be invited for a further 2-week period of daily monitoring between 2-9 months of Phase 2. The purpose of the second phase of daily monitoring is to assess the influence of seasonality (different seasons) on the patient's asthma.
0 xxxx 1 ------ 2 ------ 3 ------ 4 yy-- 5 ------ 6------ 7 ------ 8 ------ 9 ------ 10 ------ 11 ----- 12
Figure 1. Schematic of study design. 0 1 2.., months; xxxx, first series of 4 weeks daily monitoring; ------ 11 months weekly monitoring; yy--, example of second series of 2 weeks daily monitoring during month 5 (the timing of this 2 weekly phase will be randomised over month 2-9).
A variety of measurements will be made at an induction visit and over the 12-month home-monitoring period, as detailed below:
Induction visit
Demographics - Age (yr), gender, nationality, ethnicity, body mass (kg), height (cm), body mass index (BMI), comorbidities, medication, previous moderate and severe asthma exacerbations in preceding 12 months, previous severe asthma exacerbations requiring hospital attendance / admission (No in preceding 12 months), number of intensive care admission for asthma (ever), smoking history and social economic status.
Questionnaires
Clinical tests
- Atopic status will be determined via previous skin-prick test or blood test results.
(If a patient's atopic status is unknown, a standard skin-prick test or blood test will be conducted).
Phase 1 (first 4-week daily monitoring)
The measurements in Phase 1 will be collected during the first 4 weeks of monitoring, and will be self-administered by the participant. Measurements will occur continuously, daily, weekly or less frequent, as specified below:
Questionnaires
Physiological monitoring
Environmental
Phase 2 (month 2-12) The measurements in Phase 2 will occur continuously, weekly or less frequent, as specified below. The weekly measurements will occur on a fixed day of the week, determined by participants for convenience, and all the measurements will be self-administered by the participant.
Questionnaires
Physiological monitoring
Environmental
- Retrospective collection of environmental conditions for patients home and work address, as detailed above.
A second series daily monitoring (as described in phase 1) will be performed over a two week period, randomised between 2 to 9 months.
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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:
| 1 year & preliminary analysis after 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| User acceptence | User acceptance of each mHealth and home-monitoring system, as determined by user-adherence and the After-Scenario Questionnaire feedback (ASQ) | 1 year & preliminary analysis after 1 month |
| Asthma Control using asthma control questionnaire |
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Inclusion Criteria:
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)
Exclusion Criteria:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of South Manchester | Manchester | m23 9lt | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39661964 | Derived | 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. | |
| 28119390 | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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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. |
| 1 year |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |