None listed
Conditions
Brief summary
COPD (Chronic Obstructive Pulmonary Disease) is a chronic lung disease, usually caused by cigarette smoking, which leads to gradual worsening breathlessness and cough. People with COPD can experience frequent flare-ups (exacerbations) of their condition. These flare ups usually require significant and increasing health-care attention, and often hospital admission. Unfortunately some people with COPD delay seeking medical attention for their flare ups and this causes the condition to worsen and then an ambulance is called. The group of researchers involved in this project have previously used automated monitoring of reliever inhaler use by people with COPD to determine if their health is worsening and predict their likely risk of a flare up. This has led to the development of an exacerbation alert. We now want to establish a response to this alert to help people with COPD manage their flare ups early. This response will be individualised and delivered by the patients general practice team. We will measure the cost of this response and determine if it decreases unplanned trips to hospital, and also if patients quality of life is improved by this exacerbation management strategy.
Interventions
The intervention to be trialled is a response to the alert triggered by the exacerbation risk prediction algorithm resulting from Bayesian network analysis of reliever inhaler use (collected by Adherium smartInhalers), and baseline health data. The refinements to the sensitivity and specificity of the alert will occur during the initial phase of this study which is anticipated to take 6 months. The response will be trialled over a 12 month period. Depending on the sensitivity of the alert the re
The intervention to be trialled is a response to the alert triggered by the exacerbation risk prediction algorithm resulting from Bayesian network analysis of reliever inhaler use (collected by Adherium smartInhalers), and baseline health data. The refinements to the sensitivity and specificity of the alert will occur during the initial phase of this study which is anticipated to take 6 months. The response will be trialled over a 12 month period. Depending on the sensitivity of the alert the response will occur within 24hrs of the trigger. The response will be a phone call by the practice nurse from the patient’s general practice, supported by a view of the patient’s electronic medical record, to assess the patient’s situation and any concerns. The number of time the intervention (response to alert) will be delivered depends on the alert trigger frequency, and will initially be phone contact, however if felt appropriate, a subsequent direct patient contact, usually in the patient’s general practice (during office hours), or in the 24 hour surgery out of hours will be arranged.
Sponsors
Canterbury District Health Board
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Enrolled at participating practice Smoking-related chronic obstructive pulmonary disease (COPD) Able and willing to provide written informed consent to participate. Currently prescribed and using metered dose inhalers (MDI) for reliever medication (Duolin, Respigen, Ventolin) Two or more exacerbations requiring antibiotics in the last 12 months OR Admitted to hospital with exacerbation or COPD related illness in the last 3 years.
Exclusion criteria
Significant medical co-morbidity which, in the opinion of the investigators, would significantly impact on their ability to participate in the study. In hospital level care facilities. Significant cognitive impairment. Living outside Canterbury or has plans to move in next 6 months. Unable or unwilling to use study devices, including requires haleraid to use MDI Participation in other research studies that would interfere with this one.
Outcome results
None listed