None listed
Conditions
Brief summary
Prior to the COVID-19 pandemic there was growing recognition that at-home health monitoring programs based on a digital technologies could be used to empower community-based COPD patients to independently monitor their symptoms and act on rapid declines in health status. The 'SPHERE COPD' study is an early pilot study aims to test the feasibility and user-friendliness of a newly developed portable and patient-operated disease monitoring system in a community setting, Centered around a novel smartphone application ("app"), patients can take daily measurements of their lung function, oxygen levels in their blood and track their symptoms and rescue medication use. the app will summarise the data for the participant and securely transmit it to a server for interpretation by a healthcare professional. Deteriorations in participant condition potentially indicative of an exacerbation may be identified by the healthcare professional and queried via a telephone call. The downstream implications this study to completion are broad but have the potential to alter current approaches to COPD in the community. It may empower the individual to proactively identify an exacerbation and seek early medical assistance. It may also enhance their care by s providing physicians to access to longitudinal data on their patient’s condition between visits provides a powerful new tool with which they can more accurately tailor pharmacotherapies and written COPD action plans to optimise long-term outcomes.
Interventions
A patient-operated smartphone application with a bluetooth-tethered fingertip pulse oximeter and peak flow meter. Patients will be trained on the operation of the devices and instructed to take once-daily measurements and answer a brief study-specific questionnaire for approximately 5 minutes per day for 14 weeks.
The data will be reviewed each day by a physician for early identification of acute worsening of patient condition. Upon identification of a potential episode of acute worsening of th
A patient-operated smartphone application with a bluetooth-tethered fingertip pulse oximeter and peak flow meter. Patients will be trained on the operation of the devices and instructed to take once-daily measurements and answer a brief study-specific questionnaire for approximately 5 minutes per day for 14 weeks. The data will be reviewed each day by a physician for early identification of acute worsening of patient condition. Upon identification of a potential episode of acute worsening of the patient condition a study physician will contact the patient via nominated phone number and discuss their condition and instruct them to follow/escalate to a new stage of their pre-designed COPD action plan (Lung Foundation Australia format) personalised to the patient for this study. Adherence will be monitored via the physician and assessed via the frequency of data recorded.
Sponsors
The George Institute for Global Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Evidence of spirometrically confirmed airflow obstruction, defined as a post-bronchodilator FEV1/FVC ratio <0.7 and post-bronchodilator FEV1 between 30% and 70% predicted, recorded within 1 year of screening 2. Report one or more of the following symptoms within the preceding two weeks: shortness of breath, chronic cough and sputum 3. Hospitalisation for worsening COPD (exacerbation) on one or more occasions in the two years prior to commencement of study procedures 4. Be ambulatory and self-caring at the time of recruitment
Exclusion criteria
1. Have experienced an exacerbation in the 30 days prior to screening 2. In the opinion of the investigator will not complete the study or adhere to the intervention 3. In the opinion of the investigator, have an inadequate mastery of English to communicate with study staff 4. Is unable to independently provide consent
Outcome results
None listed