Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000635763
Ethics application status
Approved
Date submitted
9/05/2013
Date registered
5/06/2013
Date last updated
26/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Home Monitoring of Chronic Disease for Aged Care
Scientific title
The effect of a home telehealth intervention on healthcare outcomes and socio-economic variables in older people with chronic disease compared to a case matched control group
Secondary ID [1] 282481 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congestive Heart Failure (CHF) 288913 0
Chronic Obstructive Pulmonary Disease (COPD) 289112 0
Coronary Artery Disease (CAD) 289147 0
Diabetes 289148 0
Hypertensive Diseases 289149 0
Asthma 289150 0
Health Services Research 289151 0
Condition category
Condition code
Cardiovascular 289254 289254 0 0
Coronary heart disease
Cardiovascular 289446 289446 0 0
Other cardiovascular diseases
Respiratory 289447 289447 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At home telehealth service including vital signs monitoring using the TMC Home device (TGA, FDA approved, CE marked) administration of clinical questionnaires and video conferencing capability. Vital signs recorded include auscultatory blood pressure, single lead ecg, spirometry, blood glucose, pulse oximetry, body temperature and body weight.) Data uploaded to clinical web site for processing and review by clinical staff. Capability for setting thresholds and automated alarms.
Patient is prompted to take vital signs and answer questionnaires on a daily basis. The monitoring period is at least 12 months, subject to availability of NBN connectivity. Adherence is monitored through automated analysis of computerised logs and routine surveillance of incoming data by one or more clinical care coordinators
Training
Comprehensive training on installation and use of the TMC Telehealth system was undertaken off-site over a three day period to Project Officers and Clinical Care Coordinators nominated form each trial site. These train the trainer sessions were carried out by trained and experienced Telemedcare staff. Once patients consent and NBN connectivity to their home is provided, the TMC system is installed by the trained Project Officer with telephone support by TMC staff if necessary. Because of the intuitive patient interface and large graphical display, patient training in use of the TMC system typically requires less than an hour. For the first week of monitoring, the quality of patient data being received is carefully reviewed and remedial action is taken via telephone and video conference to correct any problems with measurement technique. As the graphical data is recorded, it is easy to identify and remedy errors in measurement technique.
Video Conferencing
The TMC system provides video conferencing capability between the patient and any member of his/her care team. Video conferencing however is not a formal part of the intervention and is used on a as-needed basis to keep in touch with the patient, review patient data, manage any patient queries and improve measurement technique.
Questionnaires
A comprehensive questionnaire is delivered to Test and Control patients at the start and at the end of the trial. This questionnaire is a compendium of the standard CSIRO Screening Medical Questionnaire available on;
http://my.csiro.au/Support-Services/Human-Research-Ethics-in-CSIRO/Health-and-Medical-Research-Ethics/Human-Research-Ethics-Committee.aspx#1
and a number of other validated questionnaires as described below;

Section 1 Q1-13 *CSIRO Demographics Questionnaire + additional trial specific questions
Section 2 Q1-5 CSIRO Demographics Questionnaire + additional trial specific questions
Section 3 Q1-2 CSIRO Demographics Questionnaire
Q3-7 *^Selected questions from Living with Diabetes Study1
Q8-12*^Selected questions from Fat and Fibre Barometer2
Section 4 Q1-9 Active Australia3
Section 5 Q1-10 Kessler 104
Section 6 Q1-16 Dimensions from HeiQ5
Section 7 Q1-6 EQ-5D6
Section 8 Q1-5 Dimensions from HeiQ5
Section 9 Q1-8 Morisky Medication Adherence7

*Additional questions were added relating to level of education, marital status, household earnings, social support computer skills, use of social media, NBN status, health care services utilised
*^These questions will not be scored, but only used for comparison between groups.

References

1. Donald M, Dower J, Ware R, Mukandi B, Parekh S, Bain C. Living with diabetes: Rationale, study design and baseline characteristics for an australian prospective cohort study. BMC Public Health. 2012;12:8
2. Wright JL. The fat and fibre barometer, a short food behaviour questionnaire: Reliability, relative validity and utility. Australian Journal of Nutrition and Dietetics. 2000;57:33-39
3. Australian Institute of Health & Welfare. The active australia survey: A guide and manual for implementation, analysis and reporting. Canberra; 2003.
4. Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychological medicine. 2002;32:959-976
5. Osborne RH, Elsworth GR, Whitfield K. The health education impact questionnaire (heiq): An outcomes and evaluation measure for patient education and self-management interventions for people with chronic conditions. Patient Educ Couns. 2007;66:192-201
6. Group EuroQoL: a new facility for the measurement of health-related quality of life. Health Policy, 1990. 16: p. 199-208.
7. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986;24:67-74

A career stress questionnaire will be administered to the carer of test patients at the start of the project, mid point and exit point.

During the trial the following questionnaires are administered using the TMC device at the frequency indicated;
A. Quality of Life ( EQ5D) on a weekly basis
B. The Mental Health (K10) on a monthly basis
C. Social Isolation, Medical Adherence, Self Care : administered @ mid point e.g 6 month.

A CHF and COPD clinical questionnaire is also administered on a daily basis to appropriate patients, to assess the patient's own perception of their condition. These data are also used as part of the risk stratification research being undertaken in this trial. The 5-6 questions asked were developed by Clinicians at the Austin Hospital for an earlier trial and have been adopted for this trial.
Intervention code [1] 286970 0
Prevention
Intervention code [2] 287130 0
Treatment: Devices
Comparator / control treatment
Intervention Control design.
Similar to a Case-Control Design.
Test patients are subject to the intervention. Control patients receive normal care. Both Test and Control patients will be monitored via Medicare supplied PBS and MBS data (subject to approval by Dept. of Human Services) as well as Hospital Records.
Control group
Active

Outcomes
Primary outcome [1] 289363 0
Primary Outcome 1: Deploy and demonstrate operation of NBN enabled telehealth in a multi-site, multi-state case matched control (BACI Design) trial of chronically ill patients living in their own homes in the community.

Assess outcomes by statistical analysis of overall performance of the trial with respect to numbers deployed, duration of monitoring, level of patient compliance, acceptability to clinical staff etc.
Timepoint [1] 289363 0
Timepoint: at one year after service commences
Primary outcome [2] 289364 0
Primary Outcome 2: Evaluate the reduction of unscheduled admissions to Accident and Emergency (A&E) in each of the six test sites compared to the control group.

Outcomes to be assessed through a statistical analysis of Hospital Records.
Timepoint [2] 289364 0
Timepoint: at one year after service commences
Secondary outcome [1] 302318 0
Secondary Outcome 1: Demonstrate significant reductions in clinical events and symptoms and improvements in functional measures as well as patients' and carers’ experiences with care.

Outcomes to be assessed from a statistical analysis of data logs from TMC device, as well as PBS and MBS data, subject to approval from Department of Human Services. Here a range of methods will be used ranging from multidimensional scaling and correspondence analysis for the survey data followed by some log-linear models. However the review of hospitalisation history for the duration of the trial will be evaluated using generalised linear mixed effects models, and the length of stay in hospital data will be modelled using either zero adjusted mixed linear effects models or mixed linear effects models.
Timepoint [1] 302318 0
Timepoint: at one year after service commences
Secondary outcome [2] 302319 0
Secondary Outcome 2: Evaluate health economic benefits

Outcomes to be assessed from a statistical analysis of PBS and MBS data, subject to approval from Department of Human Services. Here a range of methods will be used ranging from multidimensional scaling and correspondence analysis for the survey data followed by some log-linear models. However the review of hospitalisation history for the duration of the trial will be evaluated using generalised linear mixed effects models, and the length of stay in hospital data will be modelled using either zero adjusted mixed linear effects models or mixed linear effects models.
Timepoint [2] 302319 0
Timepoint: at one year after service commences
Secondary outcome [3] 302320 0
Secondary Outcome 3: Evaluate impact on clinical work force availability, deployment and cost.

Outcomes to be assessed via structured interviews and the statistical analysis of activity logs recorded by clinical staff involved in the project. Analysis of GP attendances and access to other allied health services will be from a statistical analysis of PBS and MBS data, subject to approval from Department of Human Services.

Timepoint [3] 302320 0
Timepoint: at one year after service commences
Secondary outcome [4] 302321 0
Secondary Outcome 4: Evaluate impact of human factors (acceptability, usability by patients, carers, nurses, GPs and administrators)

Outcomes will be assessed by statistical analysis of questionnaire data obtained from Test patients as well as members of their clinical care teams. Structured interviews will be used in some circumstances

Questionnaires used in this study have been comprehensively described in an earlier section. They are in the main validated questionnaires well known in the literature , other than for 5-6 daily questions on CHF and COPD symptoms developed by Clinicians at the Austin Hospital for an earlier trial.
Timepoint [4] 302321 0
Timepoint: at one year after service commences
Secondary outcome [5] 302322 0
Secondary Outcome 5: Evaluate impact of workplace culture
Workplace culture refers to values and systems which help to identify the operation of the Chronic Disease management programs in place and how they respond to the intervention of introducing a telehealth service.

Outcomes will be assessed primarily through structured interviews.
Timepoint [5] 302322 0
Timepoint: at one year after service commences
Secondary outcome [6] 302323 0
Secondary Outcome 6: Evaluate impact on business processes and the requirement for organisational change management

Outcomes will be assessed primarily through data gathering and structured interviews with clinical management and administrative staff.
Timepoint [6] 302323 0
Timepoint: at one year after service commences
Secondary outcome [7] 302324 0
Secondary Outcome 7: Develop new evidence based data analytical techniques for the risk stratification of patients’ health status on a daily basis.

Here two approaches will be used.

1. The first is using only the daily measurement (time series data) coming from the Telemedcare device. Here we will using dynamic principal component methods to monitor and visualise significant changes in mean, variance and correlation.
2. The second method with use daily measurement, hospital records plus prescribed medication (if available) to estimate the risk of the patient being hospitalised. This will use both time series data and longitudinal influences.

Test the acceptability and useability of these new services to clinicians engaged in patient care.

Outcomes will be assessed primarily through the statistical analysis of such questionnaires as the System Useability Scale (SUS), as well as User acceptance and Satisfaction questionnaire. The questionnaire data being collected has been previously described in an earlier section.
Timepoint [7] 302324 0
Timepoint: at one year after service commences
Secondary outcome [8] 302326 0
Secondary Outcome 9: Demonstration, with the support of the NSW Dept. of Health, of connectivity of the home telehealth record to the Personally Controlled Electronic Health Records (PCEHR) developments in Greater Western Sydney.

Outcomes will be assessed by successful completion of all regulatory, administrative and security requirements to permit the uploading of reports generated from patient data collected at home to the patient's own PCEHR record
Timepoint [8] 302326 0
Timepoint: at one year after service commences

Eligibility
Key inclusion criteria
1. Potential subjects must be known to a Chronic Disease Management, Coordinated Care or Connected care program operating in the area and must be in the care of a carer, community nurse and GP. Patients on EACH packages are specifically excluded.

2. Patients will be identified by way of disease group (ICD Code), by age and by frequency of admission from Hospital Records from Hospitals in each catchment area.

3. Chronic conditions included: Diabetes, Congestive heart failure (CHF), Coronary Artery Disease (CAD), Chronic Obstructive Pulmonary Disease (COPD) and Hypertension (High blood pressure) as defined by the relevant ICD Codes. Exclusions: Cancer, Neuromuscular (MS, Parkinsons etc) or Psychiatric conditions are not classified as suitable chronic conditions for the purpose of this study.

4. Patients will be selected as potential participants in the program if they are:
i. Aged as 50 years old and over
ii. Have a cognitive capacity equivalent to an
MMSE–2 score > 25.
iii. Not on renal dialysis or chemo-therapy.
Have had either
iv. At least two unplanned acute admission in the
last 12 months with one or more chronic
conditions listed in (3) as their principal diagnosis:
or
v. At least four (4) unplanned acute hospital
admission over the previous 5 years, with one or
more chronic conditions listed in (3) as their
principal diagnosis:
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cancer, Neuromuscular Disease (MS, Parkinson’s etc) and Mental Health conditions are not classified as suitable chronic conditions for the purpose of this study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Intervention-Control Design

Our previous ethics approval documentation outlined a randomized control test (RCT) design for the study, however due to the low numbers of people expected in NBN enabled regions are expected to be too low to carry out our original planned RCT design. We have changed our design to an intervention control design (similar to a Case-Control Design). This study design is outlined below.

Assumptions:
1. The entire population is well represented by the six
selected regions.
2. NBN enabled geography is identical to the non-NBN
enabled geography within each of the six selected
regions

Quasi Case-Control Design:

Within each region we will select all the patients that satisfy the study design criteria, i.e., at least two hospitalisations within the past year for any of the conditions included in the study, or related conditions.

These are divided in test/intervention and control patients in the following way.

The test/intervention patients will involve two groups of patients:

1. All the patients in NBN enabled geography with no
NBN access. These patients will be included in the
study as part of the test group provided that they
consent to being part of the study.
2. All the patients in NBN enabled geography with NBN
access. These patients will be included in the study
as part of the test group provided that they consent
to being part of the study.

An indicator variable of whether the patient had NBN prior to the study will be documents to see if these two groups differ in the outcomes of the study.

The control patients will be the set of patients that match to the individual test/intervention patients in terms of all the information in the past five years of history of hospital records. Each test patient will be matched to the eight closest in terms of age, gender, co-morbidities (hospitalization history) and postal code. The best 4 matches that consent to be part of the study will be included as controls. Each test patient will be match to 4 mutually exclusive sets of patients (if possible), i.e., control patients are matched to one and only one test patient.


Before-After effects

Baseline measurements will be taken using hospital records and just prior to the study started survey, and this will be used to assess the before intervention state of the patient, while hospital records and the exit study survey will be used to assess the after study impact. This study is therefore similar in spirit to a before-after-control-impact (BACI) study.

Selection Procedure
Patients who satisfy the selection criteria are selected from the whole catchment area for the dominant Public or Community Hospital in that location.
N eligible patients in NOT NBN ENABLED Locations
M Eligible Patients in NBN Enabled Locations
M1 Already connected to NBN
M2 Not yet connected to NBN

Selection of possible TEST and Control Group members
1. Select all of M2 and randomly 1/3 of M1. Put remaining
2/3 of M1 in the potential Control pool. Total number
of potential Test subjects now T = M2 + 1/3 M1. Total
Number of patients in Control pool C = N + 2/3 M1
2. Attempt to match All of Test Group, T patients with at
least four patients in the Control pool.

Matching of each Test patients may be attempted with as many as x4 Control patients. Control patients can be matched to one and only one Test patient. If a potential Test patient cannot be matched, REMOVE from potential Test pool
3. Consent each Test patient.
a. If Test patient refuses, return the four matched
controls into the pool of potential control patients
b. If Test patient consents, then match that patient
with two closest matches from the four matched
Control patients.
c. Consent potential matched Control patients. If
one of matched Control patients refuses move
down the list of matched Controls.
d. If ALL refuse then attempt a further match from
the remaining pool of Control patients.
e. If no match can be found remove that Test
patient from the Test pool

4. Continue (2) above until all T patients in Test pool are
either matched or have been rejected.
5. If number of Test patients that have consented and
have matched controls is < 25, randomly select the
balance from the pool of remaining controls and
undertake matching as before. These patients will be
supplied with NBN like services and a flag will need to
be set in their OpenClinica record to identify this as a
co-variant


Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Control group completes comprehensive questionnaires at point of entry and point of exit of trial.
Medicare records (PBS and MBF) will be used for comparison over time of use clinical resources and clinical outcomes (ie visits to GPs, hospital, allied health etc)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power Calculations for each Trial Site:
All patients selected for this study have complex chronic diseases, with multiple co-morbidities that lead them to be hospitalized with an average probability of P0 in any one year period. If an experimental study group is made up of case matched patients with chronic disease with the identical a priori risk of hospitalization to a Control Group, an intervention based on telehealth monitoring, self management and nurse follow up should result in a reduction in the probability of hospitalization to say P1. The null hypothesis attempts to show that no variation exists between two groups. This is presumed to be true until statistical evidence nullifies it for an alternative hypothesis. The null hypothesis assumes that any kind of difference or significance you see in a set of data is due to chance.
In our case, consider the following;
Control Data Proportion (%) of cases hospitalized P0
Number of Samples m x N
Test Data Proportion (%) hospitalized P1
Number of samples (subjects) N
The null hypothesis is that following a period of say 12 months intervention the average rate of hospitalization of the control group (P0) and the test group (P1) are NOT statistically different.
Study variables
Type of study: Dichotomous
This study is dichotomous because the outcome variable can only take two values, typically in our case whether the intervention has been a success or a failure in reducing the rate of hospitalization by the defined margin.
Prospective Study:
This is a prospective Study because the outcome variable denotes events in subjects receiving different treatments. That is;
Test Group: N Chronically ill patients with an a priori probability P0 of being admitted to hospital because of an exacerbation of their condition. Patients receive TELEHEALTH MONITORING and follow up.
Control Group: m x N Chronically ill patients with an a priori probability P0 of being admitted to hospital because of an exacerbation of their condition. Patients receive NORMAL care.
(Note: m is the ratio of control to experimental subjects)
The two groups are INDEPENDENT because the outcomes of the control group and the test group are uncorrelated
The Alternative Hypothesis is expressed in terms of the two proportions, P0 and P1
Data will be analysed using Fisher’s Exact-test or with a continuity corrected chi-squared test.
Parameters selected:
a = 0.05 Type I error probability for a two sided test.
This is the probability that we will FALSELY reject the null hypothesis.
Power=0.8 The Power with which a given sample size can detect a specific alternative hypothesis with a specific Type I error probability of a
If we select;
1. P0, the probability of outcome (hospitalization) for a control patient = 0.84
2. P1, the probability of outcome (hospitalization) for a test patient = 0.50
(ie a 40% reduction in the rate of hospitalisation).
3. m, the ratio of control to experimental subjects = 2
Sample size required, using Fisher's exact test or corrected chi-squared test = 25
Number of patients in Control Group = 50

These Power Calculations are each Trial Site so that EACH is statistically robust. As there are six trial sites, the total cohort is 6 x 25 = 150 Test patients and 6 x 50 = 300 Control patients.


These Power Calculations were checked against independent calculations as per the method outlined in;

“Approaches to sample size determination in the design of clinical trials – a review”
Allan Donner, Statistics in Medicine, Vol 3, 199-214 (1984).

Statistical Analysis Methods:
A range of methods will be used ranging from multidimensional scaling and correspondence analysis for the survey data followed by some log-linear models. However the review of hospitalisation history for the duration of the trial will be evaluated using generalised linear mixed effects models, and the length of stay in hospital data will be modelled using either zero adjusted mixed linear effects models or mixed linear effects models.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2013
Actual
29/05/2013
Date of last participant enrolment
Anticipated
30/07/2013
Actual
29/12/2014
Date of last data collection
Anticipated
Actual
31/12/2014
Sample size
Target
450
Accrual to date
Final
287
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC
Recruitment postcode(s) [1] 6704 0
7250 - Launceston
Recruitment postcode(s) [2] 6705 0
7249 - South Launceston
Recruitment postcode(s) [3] 6706 0
7330 - Smithton
Recruitment postcode(s) [4] 6707 0
7304 - Deloraine
Recruitment postcode(s) [5] 6708 0
7253 - George Town
Recruitment postcode(s) [6] 6709 0
7260 - Scottsdale
Recruitment postcode(s) [7] 6710 0
7216 - St Helens
Recruitment postcode(s) [8] 6711 0
4814 - Aitkenvale
Recruitment postcode(s) [9] 6712 0
4812 - Mundingburra
Recruitment postcode(s) [10] 6713 0
4812 - Currajong
Recruitment postcode(s) [11] 6714 0
4810 - Townsville
Recruitment postcode(s) [12] 6716 0
4814 - Heatley
Recruitment postcode(s) [13] 6717 0
4814 - Vincent
Recruitment postcode(s) [14] 6718 0
4814 - Cranbrook
Recruitment postcode(s) [15] 6719 0
4812 - Gulliver
Recruitment postcode(s) [16] 6720 0
4812 - Mysterton
Recruitment postcode(s) [17] 6721 0
4812 - Pimlico
Recruitment postcode(s) [18] 6722 0
4810 - Castle Hill
Recruitment postcode(s) [19] 6723 0
4810 - North Ward
Recruitment postcode(s) [20] 6724 0
2912 - Gungahlin
Recruitment postcode(s) [21] 6725 0
2914 - Harrison
Recruitment postcode(s) [22] 6726 0
2913 - Ngunnawal
Recruitment postcode(s) [23] 6727 0
2914 - Amaroo
Recruitment postcode(s) [24] 6728 0
2913 - Palmerston
Recruitment postcode(s) [25] 6729 0
2911 - Mitchell
Recruitment postcode(s) [26] 6731 0
2602 - Watson
Recruitment postcode(s) [27] 6732 0
2913 - Franklin
Recruitment postcode(s) [28] 6733 0
2753 - Richmond Lowlands
Recruitment postcode(s) [29] 6734 0
2756 - Windsor
Recruitment postcode(s) [30] 6735 0
2756 - South Windsor
Recruitment postcode(s) [31] 6736 0
2750 - Penrith
Recruitment postcode(s) [32] 6737 0
2751 - Penrith
Recruitment postcode(s) [33] 6738 0
2756 - Bligh Park
Recruitment postcode(s) [34] 6739 0
2148 - Blacktown
Recruitment postcode(s) [35] 6740 0
2533 - Bombo
Recruitment postcode(s) [36] 6741 0
2533 - Kiama Downs
Recruitment postcode(s) [37] 6742 0
2533 - Minnamurra
Recruitment postcode(s) [38] 6743 0
2533 - Kiama
Recruitment postcode(s) [39] 6744 0
2533 - Jamberoo
Recruitment postcode(s) [40] 6745 0
2533 - Kiama Heights
Recruitment postcode(s) [41] 6746 0
2753 - Richmond
Recruitment postcode(s) [42] 6747 0
2762 - Schofields
Recruitment postcode(s) [43] 6748 0
2765 - Riverstone
Recruitment postcode(s) [44] 6749 0
2141 - Rookwood
Recruitment postcode(s) [45] 6750 0
2141 - Lidcombe
Recruitment postcode(s) [46] 6752 0
2147 - Lalor Park
Recruitment postcode(s) [47] 6753 0
2148 - Blacktown Westpoint
Recruitment postcode(s) [48] 6754 0
2143 - Regents Park
Recruitment postcode(s) [49] 6755 0
2141 - Berala
Recruitment postcode(s) [50] 6756 0
2340 - Kingswood
Recruitment postcode(s) [51] 6757 0
2550 - Kingswood
Recruitment postcode(s) [52] 6758 0
2747 - Kingswood
Recruitment postcode(s) [53] 6759 0
2135 - Strathfield
Recruitment postcode(s) [54] 6760 0
3340 - Maddingley
Recruitment postcode(s) [55] 6761 0
3340 - Bacchus Marsh
Recruitment postcode(s) [56] 6762 0
3340 - Darley
Recruitment postcode(s) [57] 6763 0
3350 - Ballarat

Funding & Sponsors
Funding source category [1] 287105 0
Government body
Name [1] 287105 0
Department of Health and Aging
Country [1] 287105 0
Australia
Funding source category [2] 287106 0
Government body
Name [2] 287106 0
CSIRO
Country [2] 287106 0
Australia
Primary sponsor type
Government body
Name
CSIRO ICT Centre
Address
cnr Vimiera and Pembroke Roads
Marsfield NSW 2122
Country
Australia
Secondary sponsor category [1] 286126 0
None
Name [1] 286126 0
Address [1] 286126 0
Country [1] 286126 0
Other collaborator category [1] 277387 0
Hospital
Name [1] 277387 0
Health Directorate (ACT Health) - Canberra Hospital and Health Services Chronic Disease Management Unit, ACT Health
Address [1] 277387 0
123 Carruthers St,
CURTIN ACT 2605
Country [1] 277387 0
Australia
Other collaborator category [2] 277388 0
Charities/Societies/Foundations
Name [2] 277388 0
Anglican Retirement Villages (Diocese of Sydney)
Address [2] 277388 0
Level 2, Century Corporate Centre,
62 Norwest Boulevard,
BAULKHAM HILLS NSW 2153
Country [2] 277388 0
Australia
Other collaborator category [3] 277389 0
Other Collaborative groups
Name [3] 277389 0
Wentworth Healthcare Limited
(Nepean-Blue Mountains Medicare Local)
Address [3] 277389 0
Suite 5B, Level 1, 61-79 Henry Street,
PENRITH NSW 2750
Country [3] 277389 0
Australia
Other collaborator category [4] 277390 0
Other Collaborative groups
Name [4] 277390 0
Townsville Division of General Practice Limited
(Townsville-Mackay Medicare Local)
Address [4] 277390 0
3/106 Dalrymple Service Road,
CURRAJONG QLD 4812
Country [4] 277390 0
Australia
Other collaborator category [5] 277391 0
Other Collaborative groups
Name [5] 277391 0
Ballarat Health Services
(Grampians Rural Health Alliance)
Address [5] 277391 0
PO Box 577,
BALLARAT VIC 3353
Country [5] 277391 0
Australia
Other collaborator category [6] 277392 0
Hospital
Name [6] 277392 0
Tasmanian Health Organisation North
Launceston Hospital
Address [6] 277392 0
274-284 Charles Street,
LAUNCESTON TAS 7250
Country [6] 277392 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289120 0
CSIRO Animal, Food and Health Sciences Human Research Ethics Committee (CAFHS HREC)
Ethics committee address [1] 289120 0
Gate 13 Kintore Ave, Adelaide BC SA 5000
Ethics committee country [1] 289120 0
Australia
Date submitted for ethics approval [1] 289120 0
Approval date [1] 289120 0
25/03/2013
Ethics approval number [1] 289120 0
13/04

Summary
Brief summary
This project will deploy, operate and evaluate a state of the art, NBN enabled telehealth system for the management of chronic disease in the community in five different states and six different clinical trial sites in partnership with a variety of public and private sector health care service providers, including Local Health Districts, Medicare Locals and not for profit health care service providers. New methods for the automated risk stratification of patients will be developed that will facilitate future large scale deployment of NBN enabled telehealth services.
Each clinical trial site will operate as a statistically independent case matched control trial with 25 Test patients supplied with NBN enabled Telehealth services and 50 patients receiving normal care. The overall patient cohort of 150 test patients and 300 control patients provide sufficient statistical power to ensure reliable and reproducible results across the whole health care sector.
This project will provide the clinical and health economic evidence on how NBN enabled telehealth services can be scaled up nationally to provide an alternative cost effective health service for the management of chronic disease in the community.
As well as demonstrating effective deployment of NBN enabled healthcare services, a number of critical success factors will be analysed. These include;
* Health care outcomes
* Health economic benefits
* Impact on clinical work force availability and
deployment
* Human factors (acceptability, usability by patients,
carers, nurses, GPs and administrators, impact on
workplace culture)
* Organisational change management and business
processes

Large scale deployment will also require automated risk stratification of patients according to their health status to ensure that the best possible response is orchestrated at the right time to avoid unnecessary hospitalisation.

In the first year of the trial, CSIRO and its partners will develop a range of sophisticated automated risk stratification algorithms based on sophisticated statistical analysis and advanced data analytics.
These were intended to be deployed and tested in the second year and the outcomes with respect to a range of healthcare outcomes, and socio-economic variables analysed and reported. However with the trial period now effectively shortened to 16 months, we will now be able to deploy the new risk stratification and decision support algorithms and evaluate useability and clinical acceptance of the service, but there will be insufficient time to rigorously evaluate the impact of this new facility on health care or socio-economic outcomes. This would require an additional eight months as initially planned.
The third major contribution that will be the development and testing of a data architecture and communication framework consistent with NeHTA National eHealth Architecture, capable of transferring telehealth data to and from the PCEHR. Since the PCEHR will ultimately synchronise with GP systems and receive data from multiple sources, this development will firmly embed telehealth data recorded by patients at home as an important adjunct to the patient electronic health record.
In addition, this project will analyse and report comprehensive health care outcome, health economic, work force and organisational change management data to provide the evidence that Government and treasury need to develop the policy and funding framework to facilitate the development of a national public and private sector market for the provision of telehealth services.
Trial website
None publicly available
Trial related presentations / publications
None publicly available
Public notes
None publicly available
Attachments [1] 2914 2914 0 0
/AnzctrAttachments/364030-National Telehealth Trial - Major Outcomes Paper.pdf (Publication)
Attachments [2] 2915 2915 0 0
/AnzctrAttachments/364030-Telehealth Trial Protocol Paper - BMC Public Health 2014-14 -1270.pdf (Protocol)

Contacts
Principal investigator
Name 39178 0
Prof Branko Celler
Address 39178 0
CSIRO
Cnr Vimiera and Pembroke Roads, Marsfield, NSW 2122
Country 39178 0
Australia
Phone 39178 0
+61 2 93724289
Fax 39178 0
+61 2 9372 4585
Email 39178 0
[email protected]
Contact person for public queries
Name 39179 0
Dr Rajiv Jayasena
Address 39179 0
CSIRO
343 Royal Parade, Parkville, Victoria 3052
Country 39179 0
Australia
Phone 39179 0
+61 3 96627383
Fax 39179 0
Email 39179 0
[email protected]
Contact person for scientific queries
Name 39180 0
Prof Branko Celler
Address 39180 0
CSIRO
Cnr Vimiera and Pembroke Roads, Marsfield, NSW 2122
Country 39180 0
Australia
Phone 39180 0
+61 2 93724289
Fax 39180 0
+61 2 9372 4585
Email 39180 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseDesign of a multi-site multi-state clinical trial of home monitoring of chronic disease in the community in Australia.2014https://dx.doi.org/10.1186/1471-2458-14-1270
N.B. These documents automatically identified may not have been verified by the study sponsor.