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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.
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.
Universal Trial Number (UTN)
Trial acronym
TRAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure (CHF) 4823 0
Condition category
Condition code
Respiratory 237164 237164 0 0
Chronic obstructive pulmonary disease
Cardiovascular 257437 257437 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 4599 0
Other interventions
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.
Control group
Active

Outcomes
Primary outcome [1] 237984 0
Number of hospital admissions.
Hospital admissions recorded by client in a diary.
Timepoint [1] 237984 0
information requested monthly for six months by phone by research team
Primary outcome [2] 237985 0
Number of emergency department visits.
Emergency department visits recorded by client in a diary
Timepoint [2] 237985 0
information requested monthly for six months by phone by research team
Secondary outcome [1] 242108 0
Health related quality of life. As measured by the Chronic Respiratory Questionnaire (COPD) and Minnesota Living with heart Failure Questionnaire (CHF)
Timepoint [1] 242108 0
Collected at baseline and post intervention
Secondary outcome [2] 242109 0
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.
Timepoint [2] 242109 0
Post intervention

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of dementia
Non-English speaking

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)
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.
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).
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
Recruiting
Date of first participant enrolment
Anticipated
15/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 4984 0
Government body
Name [1] 4984 0
Commonwealth Department of Health and Ageing and State Health Research Advisory Council
Country [1] 4984 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Silver Chain Nursing Association
Address
6 Sundercombe Street
Osborne Park, Western Australia 6017
Country
Australia
Secondary sponsor category [1] 4506 0
None
Name [1] 4506 0
Address [1] 4506 0
Country [1] 4506 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7087 0
Silver Chain Human Research Ethics Committee
Ethics committee address [1] 7087 0
6 Sundercombe Street
Osborne Park, WA 6017
Ethics committee country [1] 7087 0
Australia
Date submitted for ethics approval [1] 7087 0
12/06/2009
Approval date [1] 7087 0
23/06/2009
Ethics approval number [1] 7087 0
057

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29624 0
Address 29624 0
Country 29624 0
Phone 29624 0
Fax 29624 0
Email 29624 0
Contact person for public queries
Name 12871 0
Joanna Smith
Address 12871 0
Silver Chain research department
6 Sundercombe Street
Osborne Park WA 6017
Country 12871 0
Australia
Phone 12871 0
+61 8 9201 6724
Fax 12871 0
Email 12871 0
[email protected]
Contact person for scientific queries
Name 3799 0
Joanna Smith
Address 3799 0
Silver Chain research department
6 Sundercombe Street
Osborne Park WA 6017
Country 3799 0
Australia
Phone 3799 0
+61 8 9201 6724
Fax 3799 0
Email 3799 0
[email protected]

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