None listed
Conditions
Brief summary
Chronic diseases such as chronic obstructive pulmonary disease (COPD) are characterised by chronic, underlying organ dysfunction with intermittent acute worsening of the disease that often results in hospital admission. There is good evidence to suggest that regular monitoring of certain physiological and symptom related variables in the homes of patients with COPD may be beneficial. If deterioration can be detected early and appropriate interventions instituted, it may be possible to achieve improved patient outcomes and a reduction in the use of healthcare resources. The technology to remotely monitor relevant physiological variables in the home situation is now available and there is some evidence that these devices are robust and capable of being reliably used by patients with COPD. Randomised controlled studies in this field are needed to establish the efficacy of RPM and to better define the role of this new technology in managing these conditions. We designed a randomised controlled trial to determine whether remotely monitoring symptoms, medication usage and physiological variables over 12 months was feasible in patients with moderate-severe COPD and whether this intervention could improve quality of life or reduce healthcare use.
Interventions
Remote home-based monitoring, daily for 12 months, of the following -
Spirometry (pneumaotachograph plus custom software)
Body Weight
SaO2 (pulse oximeter)
ECG (touch plate)
BP (Automatic cuff device)
Symptoms (visual analog scale)
Change in medication usage (bronchodilators, inhaled and oral corticosteroids and antibiotics)
Sputum quantity and colour (Questionnaire)
Body temperature (armpit thermometer)
All measurement instruments are digitally integrated with a monitoring computer. Custom sof
Remote home-based monitoring, daily for 12 months, of the following - Spirometry (pneumaotachograph plus custom software) Body Weight SaO2 (pulse oximeter) ECG (touch plate) BP (Automatic cuff device) Symptoms (visual analog scale) Change in medication usage (bronchodilators, inhaled and oral corticosteroids and antibiotics) Sputum quantity and colour (Questionnaire) Body temperature (armpit thermometer) All measurement instruments are digitally integrated with a monitoring computer. Custom software with a simple user interface guides the patient through the series of measurements. All measurements are automatically logged and transmitted to a central server for review by clinical staff participating in the trial. Patients have an initial, intensive in-home training session with the equipment and further in-home troubleshooting if required. A series of measurements typically takes 20-30 minutes.
Sponsors
Austin Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Moderate-severe COPD >=1 hospital presentation in previous 12 months English language fluency Willing to use a computer for health self management Living independently
Exclusion criteria
Significant co-morbidities including cancer, renal failure, cognitive impairment.
Outcome results
None listed