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Trial registered on ANZCTR


Registration number
ACTRN12611000112965
Ethics application status
Approved
Date submitted
31/01/2011
Date registered
1/02/2011
Date last updated
15/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study of remote telemonitoring in chronic obstructive pulmonary disease.
Scientific title
Pilot study in chronic obstructive pulmonary disease of the effectiveness of remote telemonitoring on quality of life and health care utilisation.
Secondary ID [1] 253504 0
Nil
Universal Trial Number (UTN)
Trial acronym
RPM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD) 261054 0
Condition category
Condition code
Respiratory 259199 259199 0 0
Chronic obstructive pulmonary disease
Public Health 259217 259217 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 257937 0
Early detection / Screening
Comparator / control treatment
Usual care which consisted of clinical management according to Australian and New Zealand Guidelines (COPD-X) with provision of outreach nursing, a written action plan and availability of pulmonary rehabilitation.
Control group
Active

Outcomes
Primary outcome [1] 262047 0
Hospital admissions (inpatient bed days). Assessed by scanning the hospital admissions database for Austin Hospital admissions. For non-Austin admissions, patients kept a diary. Diary entries were confirmed and details obtained by contacting the admitting hospital.
Timepoint [1] 262047 0
12 months
Primary outcome [2] 262048 0
Quality of life by
1. Chronic Respiratory Disease Questionnaire (CRDQ11)
2. SF36 quality of life questionnaire
Timepoint [2] 262048 0
12 months
Secondary outcome [1] 273027 0
6 minute walk distance
Timepoint [1] 273027 0
12 months
Secondary outcome [2] 273028 0
Patient compliance assessed as the proportion of days during the trial period when measurements were made by the patient.
Timepoint [2] 273028 0
12 months

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant co-morbidities including cancer, renal failure, cognitive impairment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects were recruited by: 1) searching the Hospital admissions database for ICD codes that identified COPD patients with at least one hospital admission in the previous twelve months or 2) offering enrolment to suitable new and existing patients of the Austin Hospital Chronic Disease Management Program.

Subjects were randomly allocated to either the Active or Control group by an investigator not directly involved in the conduct of the trial using a set of sequentially numbered opaque envelopes containing randomly generated 'Active' or 'Control' designations..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence of random numbers obtained from text book tables. Odd/even used to determine Active/Control designation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258406 0
Government body
Name [1] 258406 0
Victorian Department of Human Services
Address [1] 258406 0
Department of Human Services
50 Lonsdale Street
Melbourne, Victoria
3000
Country [1] 258406 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
145 Studley Road
Heidelberg
Victoria
3084
Country
Australia
Secondary sponsor category [1] 257556 0
None
Name [1] 257556 0
Address [1] 257556 0
Country [1] 257556 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260378 0
Austin Hospital HREC
Ethics committee address [1] 260378 0
145 Studley Road
Heidelberg
Victoria
3084
Ethics committee country [1] 260378 0
Australia
Date submitted for ethics approval [1] 260378 0
18/07/2005
Approval date [1] 260378 0
Ethics approval number [1] 260378 0

Summary
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.
Trial website
Nil
Trial related presentations / publications
HOME–BASED SPIROMETRIC AND INSPIRATORY CAPACITY MEASUREMENTS IN SEVERE COPD ARE REPRODUCIBLE. Abstract presented at the 2008 ANZSRS annual scientific meeting.

REMOTE MONITORING IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) DOES NOT REDUCE HOSPITAL ADMISSIONS OR IMPROVE QUALITY OF LIFE WHEN COMPARED TO STANDARD BEST PRACTICE CARE. Abstract presented at the TSANZ 2009 Annual scientific meeting.
Public notes

Contacts
Principal investigator
Name 32148 0
Address 32148 0
Country 32148 0
Phone 32148 0
Fax 32148 0
Email 32148 0
Contact person for public queries
Name 15395 0
Prof Christine McDonald
Address 15395 0
Department of Respiratory and Sleep Medicine
Austin Hospital
145 Studley Road
Heidelberg
Victoria
3084
Country 15395 0
Australia
Phone 15395 0
061 3 9496 5760
Fax 15395 0
Email 15395 0
christine.mcdonald@austin.org.au
Contact person for scientific queries
Name 6323 0
Prof Christine McDonald
Address 6323 0
Department of Respiratory and Sleep Medicine
Austin Hospital
145 Studley Road
Heidelberg
Victoria
3084
Country 6323 0
Australia
Phone 6323 0
061 3 94965760
Fax 6323 0
Email 6323 0
christine.mcdonald@austin.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary