The Use of Home-monitoring and mHealth Systems to Predict Asthma Control and the Occurrence of Asthma Exacerbations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02774772|
Recruitment Status : Completed
First Posted : May 17, 2016
Last Update Posted : February 7, 2019
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|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|
- 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.
- 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.
- 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
- 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)
- 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.
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
|University Hospital of South Manchester|
|Manchester, United Kingdom, m23 9lt|