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Trial registered on ANZCTR
Registration number
ACTRN12609000428268
Ethics application status
Approved
Date submitted
20/05/2009
Date registered
10/06/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Telehealth Research Across The Community (TRAC): An evaluation of telehealth home monitoring of home care clients with chronic obstructive pulmonary disease or chronic heart failure compared to usual care.
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Scientific title
Telehealth Research Across The Community (TRAC): An evaluation of telehealth home monitoring of home care clients with chronic obstructive pulmonary disease and chronic heart failure compared to usual care.
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Universal Trial Number (UTN)
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Trial acronym
TRAC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure (CHF)
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Remote home monitoring of client’s vital signs by a nurse will be undertaken. The monitoring equipment is installed in the client’s home. The client is trained in the use of the equipment to measure their vital signs which will include:
a) Blood Pressure
b) Weight
c) Heart Rate
d) Oxygen Saturation Levels
In addition, clients’ response to questions regarding their general state of health or specific to their condition, such as the type of cough they are experiencing or the colour of their sputum. Readings take approximately 20 minutes for the client to complete and occur on a daily basis for a period of 6 months.
Readings are transmitted to a central point where any deviations from the norm are reviewed by a nurse and interventions introduced where required. Those interventions can be a telephone call by the clinician to retake the tests or a recommendation that the patient visit their General Practitioner.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
Usual care plus provision of information on self monitoring.
Usual care consists of the provision of oxygen and the monitoring of the clients condition by their respiratory physician and/or general practitioner (GP) as required. The provision of oxygen includes an initial clinican visit to set up the client on oxygen followed by visits at 3 months and 12 months for review.
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Control group
Active
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Outcomes
Primary outcome [1]
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Number of hospital admissions.
Hospital admissions recorded by client in a diary.
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Assessment method [1]
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Timepoint [1]
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information requested monthly for six months by phone by research team
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Primary outcome [2]
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Number of emergency department visits.
Emergency department visits recorded by client in a diary
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Assessment method [2]
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Timepoint [2]
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information requested monthly for six months by phone by research team
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Secondary outcome [1]
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Health related quality of life. As measured by the Chronic Respiratory Questionnaire (COPD) and Minnesota Living with heart Failure Questionnaire (CHF)
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Assessment method [1]
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Timepoint [1]
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Collected at baseline and post intervention
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Secondary outcome [2]
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Cost savings of home monitoring compared to usual care accounting for equipment, telephone costs, monitoring costs, hospital admissions, emergency department visits, other medical visits. First, average unit costs for equipment, hospital separations, accident and emergency occasions of service, general practitioner visits, specialist visits and post acute community care services using West Australian Department of Health and Australian Department of Health and Ageing reported figures and Silver Chain unit costs. Unit costs for monitoring and liaising will be similarly derived. Next, the data collected for the control and intervention groups will be used to estimate service utilisation that can be averaged for various sub-groups defined in terms of, inter alia, age, gender and Quality of Life (QoL). The incidence of monitoring and liaising for the intervention group will be averaged across the number of clients. Finally, unit costs will be applied to the service utilisation figures for the control and intervention groups to estimate total average costs for each group. The total costs of monitoring and liaising will be added to the total cost of services for the intervention group. A sensitivity analysis that refers to parameters used to estimate the savings in other studies identified in the literature review will be undertaken.
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Assessment method [2]
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Timepoint [2]
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Post intervention
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Eligibility
Key inclusion criteria
Have a confirmed diagnosis of COPD and are currently receiving oxygen services OR diagnosis of CHF; Do not have a diagnosis of dementia; Can communicate in English; Are not receiving palliative care; and Their specialist or GP has agreed for their inclusion and will take clinical governance
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Diagnosis of dementia
Non-English speaking
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Clients meeting the selection criteria and identified using Silver Chain’s data management system Com Care, will be invited to participate in the research by letter. The letter will explain that a Research Officer will telephone them in the next few days to discuss the research project with them. Should the client be interested in participating the Research Officer will make an appointment to visit the client in their home at a mutually convenient time and send them an information sheet about the study, a consent form, and a reminder of the appointment date and time. When the Research Officer visits they will refer to the information statement about the project and encourage the client (or family) to ask any questions they may have. When certain the client and family have asked all their questions and are still wishing to participate, the Research Officer will ask the client to sign the consent form.
Following completion of the baseline data collection when the client is allocated a study number (these are allocated sequentially), the envelope indicating which group the client’s study number has been allocated to, will be opened and the client duly informed.
Prior to the commencement of recruitment, 80 cases will have been randomly allocated to the intervention or the control group (40 in each group), by the Senior Research Officer. Envelopes will then be made up which have the study number written on the outside and contain a slip of paper with the group assignment for that number. An electronic master list of the study numbers and group allocation will be kept on a password protected computer and will not be accessible to the Research Officer doing the client recruitment.
When a client is recruited their GP and/or Specialist will be informed as to which group the client has been randomly allocated to.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random number sampling was used to obtain randomly allocate the groups using Stata, version 10 (StataCorp, College Station, Tex, USA).
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
15/06/2009
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Commonwealth Department of Health and Ageing and State Health Research Advisory Council
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Address [1]
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6 Sundercombe Street
Osborne Park, Western Australia 6017
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Silver Chain Nursing Association
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Address
6 Sundercombe Street
Osborne Park, Western Australia 6017
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Silver Chain Human Research Ethics Committee
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Ethics committee address [1]
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6 Sundercombe Street
Osborne Park, WA 6017
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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12/06/2009
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Approval date [1]
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23/06/2009
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Ethics approval number [1]
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057
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Summary
Brief summary
This project is a randomised controlled trial of telehealth self monitoring of clients with COPD and CHF. Clients in the intervention group will be provided with and trained to use telehealth equipment with which to monitor clinical vital signs which are then transmitted to Silver Chain. Deviations from the norm are reviewed by a nurse and interventions introduced where required. It is expected that cost saving will be seen as a results of fewer hospital admissions, shorter hospital stays and fewer emergency department visits when compared to a control group.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Joanna Smith
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Address
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Silver Chain research department
6 Sundercombe Street
Osborne Park WA 6017
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Country
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Australia
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Phone
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+61 8 9201 6724
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Joanna Smith
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Address
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Silver Chain research department
6 Sundercombe Street
Osborne Park WA 6017
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Country
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Australia
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Phone
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+61 8 9201 6724
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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