Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000733774
Ethics application status
Approved
Date submitted
2/07/2013
Date registered
2/07/2013
Date last updated
29/08/2019
Date data sharing statement initially provided
29/08/2019
Date results information initially provided
29/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Telehealth in the home: Testing technology to enhance support and service provision to those either living with or caring for someone with a terminal illness in the community
Scientific title
A prospective cohort study exploring the impact of offering telehealth support to palliative patients and their family caregivers to enhance the community based palliative care service.
Secondary ID [1] 282749 0
None
Universal Trial Number (UTN)
U1111-1145-0983
Trial acronym
Area 4 study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The use of telehealth in the palliative care home based community program 289482 0
Condition category
Condition code
Cancer 289803 289803 0 0
Any cancer
Respiratory 289804 289804 0 0
Chronic obstructive pulmonary disease
Neurological 289805 289805 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project using telehealth will investigate the effect of online support to the homes or primary residence of aged and palliative care patients and carers. The project will involve the provision of an iPad, with specially designed applications. The iPad home screen will have all the options loaded that are specific to the project with all other Apple applications removed. There will be an application for the patient and one for the carer. There will be a 'contact nurse' function, as well as a Facetime button to facilitate video conferencing between the nurse and patient or carer. Cisco jabber is loaded onto the iPad as the virtual case conferencing platform. The community nurse will organise a virtual clinic with the patient as part of a monitoring function and this time will be scheduled with the patient as clinically indicated. The patient is asked to complete the symptom severity tool that is loaded into the patient application function each day. An increase in symptom scores will send an automatic email alert to the community nurse who will respond when able. The patient and carer will be taught how to assess the patient functional status and this will be recorded weekly. A drop in functional score below 70% signals the need for a virtual case conference between all key health care providers. The patient and carer will be informed of the working hours of the nurse as this is not a 24 hour service, so routine provisions to access the On call service will be in place to support out of hours and on weekends. This project will not only facilitate regular and responsive online access to health professionals but will provide brokered access to quality information and resources to support palliative care patients and their carers. The education is loaded onto both the patient and carer application functions. This information is provided from the website CareSearch and is peer reviewed and evidenced based. The types of information provided include how to access community services, general information on how to care for someone with a life limiting illness, and information on Advance Care Planning. The palliative care service will test if use of information technology can be incorporated into current care processes and whether this will reduce service requirements and/or increase the number of patients that can be managed in the community as well as sustaining a patient at home for the same time or longer.
The formal project will conclude at the end of May 2014 however all patients will remain supported via this technology until death.
Intervention code [1] 287411 0
Other interventions
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289880 0
To evaluate the impact of a telehealth-based intervention on nursing time and unplanned/emergency health care utilisation in the care of palliative care patients. This will be achieved through the patient maintining a diary about health care utilisation. The nurse will record and monitor all visits undertaken through the telehealth forum and data will be assessed for median length of time for contact and saved travel time.
Timepoint [1] 289880 0
assessed weekly and as needed as alerted by the patient or their caregiver.
Primary outcome [2] 289881 0
To assess the potential of a telehealth-based intervention in replacing current usual care. Current usual care requires a face to face home visit of the patient by the nurse. At the home visit the symptom severity score and Australian Karnofsy Performance Score (AKPS) are recorded. These tools have been loaded onto the patient's i Pad and they are instructed in how to complete these on a daily and weekly basis. Once completed any deviation in scoring is automatically flagged to the nurse via an email alert. This functionality enables a responsive service determined on changing patient need.
Timepoint [2] 289881 0
The nurse will enter the data from all telehealth visits into a data sheet held by the website CareSearch every time there is a telehealth contact. The nurse will monitor the patient daily to ensure the symptom scores have been completed. Failure to complete the scores will result in the nurse making contact with the patient or carer.
Secondary outcome [1] 303465 0
To explore the acceptability and utility of telehealth-based measures.
Timepoint [1] 303465 0
An initial survey regarding participant comfort in using technology will be conducted at baseline and ongoing user acceptability will be reviewed fortnightly.
Secondary outcome [2] 303566 0
Determine longitudinal changes of activity via the wearing of the Fitbit in palliative care patients.
Timepoint [2] 303566 0
Fitbit data is automatically synchronised to the patients iPad and is available daily. Data will be reviewed weekly to look at trends over time.

Eligibility
Key inclusion criteria
Until January 2014, only Area 4 patients with the National Broadband Network (NBN) connections will be enrolled. Area 4 covers the postcodes from Noarlunga Centre to Willunga on the Fleurieu Peninsula in South Australia. After January 2014, all Area 4 patients will be enrolled and for those not able to connect to the National Broadband Network a 3G enabled iPad will be provided.
Participants must be 18 years of age or over to be eligible.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Demonstrated inability to manage the hardware or technology unless living with a carer who can manage the technology
Not able to be connected to the NBN (prior to January 2014)
Non English speaking without suitable carer/proxy.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantifying utilisation of telehealth interventions via response to patient and family caregiver alerts through symptom assessment changes. Descriptive statistics will be used to analyse relevant data.
Analysis of data pertaining to staff and patient confidence and useability of telehealth interventions will be assessed using both qualitative and quantitative measures.
The number of participants arrived upon was taken from the review of the previous years referral numbers of palliative care clients from Area 4 on the Fleurieu Peninsula. Sample size calculations were not conducted as this is a finite group and the tight project timelines mean numbers needed to be determined on what could realistically be achieved in the given timeframe.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/08/2013
Actual
5/08/2013
Date of last participant enrolment
Anticipated
30/05/2014
Actual
1/07/2014
Date of last data collection
Anticipated
Actual
31/07/2014
Sample size
Target
45
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 287522 0
Government body
Name [1] 287522 0
Department of Health and Ageing
Country [1] 287522 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
700 Goodwood Road
Daw Park
South Australia, 5041
Country
Australia
Secondary sponsor category [1] 286293 0
Government body
Name [1] 286293 0
SA Health -Department for Health and Ageing
Address [1] 286293 0
C/o Hindmarsh Square
Adelaide, South Australia
5001
Country [1] 286293 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289521 0
Southern Adelaide Clinical Human Research and Ethics Committee
Ethics committee address [1] 289521 0
The Flats G5
Rooms 3 and 4
Flinders Drive
Flinders Medical Centre
Bedford Park, SA, 5042
Ethics committee country [1] 289521 0
Australia
Date submitted for ethics approval [1] 289521 0
07/06/2013
Approval date [1] 289521 0
02/08/2013
Ethics approval number [1] 289521 0
168.13

Summary
Brief summary
The study is evaluating the impact of a telehealth-based intervention on service provision for palliative care patients as well as assessing its potential in replacing current usual care through increased video link contact opportunities and remote monitoring of patients and their carers at home. Who is it for? You may be eligible to join this study if you are aged over 18 years, require palliative care in Seaford, Aldinga, McLaren Vale and Willunga in South Australia, and have access to a National Broadband Network (NBN) connection. Trial details: Participants in this study will be provided with regular and responsive online access to health professionals, and access to quality information and resources to support palliative care patients and their carers. Participants will be monitored on a regular and ongoing basis to determine the feasibility, acceptability and utility of the telehealth-based intervention.
Trial website
Trial related presentations / publications
Public notes
Trial was completed in 2014 following final report that was prepared to the Commonwealth Government of Australia

Contacts
Principal investigator
Name 41082 0
Ms Kate Swetenham
Address 41082 0
Southern Adelaide Palliative Services
700 Goodwood Road
Daw Park
South Australia, 5041
Country 41082 0
Australia
Phone 41082 0
+61 8 82751732
Fax 41082 0
Email 41082 0
kate.swetenham@health.sa.gov.au
Contact person for public queries
Name 41083 0
Dr Deidre Morgan
Address 41083 0
Flinders University
700 Goodwood Road
Daw Park
South Australia, 5041
Country 41083 0
Australia
Phone 41083 0
+ 61 8 72218239
Fax 41083 0
Email 41083 0
deidre.morgan@flinders.edu.au
Contact person for scientific queries
Name 41084 0
A/Prof Jennifer Teman
Address 41084 0
Flinders University
700 Goodwood Road
Daw Park
South Australia, 5041
Country 41084 0
Australia
Phone 41084 0
+61 8 72218237
Fax 41084 0
Email 41084 0
jennifer.tieman@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This required field only enacted in 2018. Study completed in 2014


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Designing Clinically Valuable Telehealth Resources... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseUsing telehealth to support end of life care in the community: a feasibility study.2016https://dx.doi.org/10.1186/s12904-016-0167-7
N.B. These documents automatically identified may not have been verified by the study sponsor.