None listed
Conditions
Brief summary
Chronic respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD) cause a major burden in Australia, particularly following an exacerbation that can lead to emergency department visits and hospital admissions. This study will evaluate whether the ENGAGEMENT model of care can help people better manage their condition, improve quality of life, and reduce healthcare use. The ENGAGEMENT program combines support from trained nurses with a personalised action plan, telehealth consultations, electronic monitoring of inhaler use, and a mobile phone app to track symptoms and medicines. Adults with asthma or COPD who have recently experienced an exacerbation will be recruited through hospitals and general practices in Victoria. A total of 400 participants will be randomly allocated to receive either the ENGAGEMENT intervention in addition to usual care or usual care alone. We hypothesise that participants receiving the ENGAGEMENT intervention will have improved health-related quality of life, better disease control and self-management, and fewer hospitalisations and emergency department presentations than those receiving usual care.
Interventions
The ENGAGEMENT trial will evaluate a nurse-supported, technology-enabled self-management model of care for adults with asthma or chronic obstructive pulmonary disease (COPD) following a recent acute exacerbation. The intervention comprises an individual face-to-face baseline consultation (up to 90 minutes) with a trained study nurse, personalised education on disease management, medication use, inhaler technique, symptom recognition and self-management, development of an individualised asthma or
The ENGAGEMENT trial will evaluate a nurse-supported, technology-enabled self-management model of care for adults with asthma or chronic obstructive pulmonary disease (COPD) following a recent acute exacerbation. The intervention comprises an individual face-to-face baseline consultation (up to 90 minutes) with a trained study nurse, personalised education on disease management, medication use, inhaler technique, symptom recognition and self-management, development of an individualised asthma or COPD action plan, and access to the ENGAGEMENT digital health platform. The platform includes symptom monitoring, medication reminders, educational resources, secure messaging with the study nurse, and integration with an electronic inhaler monitoring device and a Bluetooth-enabled peak flow meter (asthma) or micro spirometer (COPD). Intervention participants will receive individual telehealth follow-up consultations at approximately 2, 6, 12 and 24 weeks after baseline, with each consultation lasting approximately 30 minutes. The nurse-supported component of the intervention is delivered over the first 24 weeks. Participants will continue to have access to the ENGAGEMENT digital health platform, connected monitoring devices, educational resources, symptom monitoring, medication reminders, and secure messaging with the study nurse for the duration of the 18-month study period. Education will be delivered by the study nurse during the baseline consultation and reinforced during follow-up telehealth consultations and through resources available within the ENGAGEMENT platform. Educational content will be tailored to the participant's respiratory condition, clinical needs and individual goals, and will include inhaler technique, medication use and adherence, recognition and management of worsening symptoms, use of the personalised action plan, self-monitoring of symptoms and lung function, smoking cessation (where appropriate), vaccination recommendations, and other self-management strategies. The intervention will be delivered by trained study nurses across participating healthcare services. All study nurses will receive standardised training delivered by members of the study team prior to participant recruitment. Training will include delivery of the intervention, participant education, use of the ENGAGEMENT platform and connected devices, telehealth consultation procedures, and study-specific processes to ensure consistent delivery of the intervention across all sites.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years or older with asthma or chronic obstructive pulmonary disease (COPD) who have experienced a recent moderate-to-severe acute exacerbation requiring a short course of oral corticosteroids with or without antibiotics initiated in hospital or general practice, and/or have had an unplanned general practice visit, emergency department presentation, or hospital admission for their respiratory condition within the past 12 months. Participants must own a smartphone and be able to provide informed consent.
Exclusion criteria
Participants will be excluded if they are unable to provide informed consent (e.g. due to cognitive impairment), are unable to communicate in English, have difficulty following the intervention, are unwilling to engage with the digital aspects of the intervention, have a terminal illness (anticipated survival <12 months), have symptoms suggestive of unstable heart disease, or have contraindications to spirometry according to standard guidelines.
Outcome results
None listed