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Trial registered on ANZCTR
Registration number
ACTRN12619000055101
Ethics application status
Approved
Date submitted
19/11/2018
Date registered
15/01/2019
Date last updated
15/10/2019
Date data sharing statement initially provided
15/01/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
A pilot ranDomisEd trial of nurSe-led patIent follow-up using a diGital platform to reduce re-admissioNs after an acute presentation with Heart Failure. (DESIGN-HF)
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Scientific title
A pilot ranDomisEd trial of nurSe-led patIent follow-up using a diGital platform to reduce re-admissioNs after an acute presentation with Heart Failure. (DESIGN-HF)
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Secondary ID [1]
296378
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Nil known
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Universal Trial Number (UTN)
U1111-1222-6594
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Trial acronym
DESIGN-HF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
310121
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Public health
310629
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Condition category
Condition code
Cardiovascular
308872
308872
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0
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Other cardiovascular diseases
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Public Health
309349
309349
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
DESIGN-HF is a randomised study to measure the usefulness of the Personify Care clinical pathway/ surveillance platform to both the patient and heart failure (HF) care team, and assess its potential impact on HF hospital readmission. Potential participants will be assessed for their ability to use a website on a digital system (eg. mobile phone, tablet, or computer) and regularity of access to such a device and internet/wifi. This will determine if participants are eligible to take part in the study.
The assessments conducted by Heart failure nurses (HFN) have been translated into a digital platform, PersonifyHF. After gaining informed consent, participants randomised to the intervention arm will receive a text message prompting them to register on the PersonifyHF platform. During the follow-up period participants are prompted via text messages to log in and complete assessments usually performed over the phone by a HFN. During the online assessments participants will be prompted to answer additional questions depending on answers given. This includes the additional questions the HFN asks as part of ascertaining overall status of their heart failure patient, and rephrases certain formal assessment questions in the same manner the HFN does while speaking with the patient when conducting such assessments over the phone. If certain answers to particular questions are given the participant will be prompted to take action which include calling an ambulance in the case of a life threatening emergency or to contact the HFN within a given time frame (e.g. within 2 hours). Depending on answers given in the assessment the database will flag the HFN to contact the participant within a certain time frame. The HFN will also be flagged to contact the participant if the online assessment has not been completed within 4 working days of scheduled. When the database flags a participants response the HFN will receive a text message informing them of the timeframe required to respond. The frequency of assessments are the same as standard telephone follow-up. The standard care model for HF post-discharge follow-up is based on the Australian Heart Foundation Heart Failure Clinical Guidelines. A more detailed description of the follow-up timeframes are given below.
Recruited participants will be randomised 1:1 to the intervention and the standard care control:
Control: Standard evidence-based transition of care nursing model; specifically:
• Standard home visit 1-week post-discharge
• Follow-up phone calls by nurse at 2, 4, and 6 weeks post-discharge
• Follow-up phone calls by nurse at 3 and 6 months post-discharge
• Nurse-initiated additional clinical care as directed by patient response, eg. investigative testing, medication adjustment, clinical appointments.
Intervention: Protocolised contact and clinical care guided by nurse surveillance of patient-entered data using the Personify Care platform synergistically with the standard evidence-based transition of care nursing model; specifically:
• Standard home visit 1-week post-discharge
• Nurse surveillance of patient-entered data at 2, 4, and 6 weeks post-discharge
• Nurse surveillance of patient-entered data at 3 and 6 months post-discharge
• Nurse-initiated additional clinical care as directed by patient response, eg. investigative testing, medication adjustment, clinical appointments.
Both groups:
• Except for the digital platform evaluation which will be provided to the intervention group at the 6 month visit, all assessments throughout the project are as per standard HF care but via different methods for initial communication.
• All participants will receive a standard, evidence-based transition of care home visit at 1 week post-discharge, regardless of study randomisation.
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Intervention code [1]
312714
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Other interventions
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Comparator / control treatment
Standard evidence-based transition of care nursing model; specifically:
• Standard home visit 1-week post-discharge
• Follow-up phone calls by nurse at 2, 4, and 6 weeks post-discharge
• Follow-up phone calls by nurse at 3 and 6 months post-discharge
• Nurse-initiated additional clinical care as directed by patient response, eg. investigative testing, medication adjustment, clinical appointments.
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary endpoint of this study will be defined as re-admission to hospital for heart failure, evidenced by breathlessness and clinical signs of volume overload (elevated JVP, crepitations in lung fields, or SOA) together with an elevated NT-proBNP, or via admission to hospital with ICD-10AM code of I50.X in any of the top 5 diagnosis positions. This outcome will be sourced from hospital records and databases.
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Assessment method [1]
307842
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Timepoint [1]
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12 Months post hospital discharge
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Primary outcome [2]
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Evaluation of cost-effectiveness: HF specialist nursing care utilisation will be measured and compared between standard care and intervention arms over the length of the follow-up. Utilisation of nursing care will be assessed by logging the time needed by the HF nurse on each participant including; face to face, telephone, and online review of patient entered data. The HF nurse will keep a log of all time spent engaged in nursing care for each participant.
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Assessment method [2]
307843
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Timepoint [2]
307843
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12 Months post hospital discharge
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Secondary outcome [1]
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Death: All cause mortality and cardiovascular mortality
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Assessment method [1]
353107
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Timepoint [1]
353107
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12 Months post hospital discharge
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Secondary outcome [2]
353108
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Days free from hospital admission: From a patient-focused perspective, this outcome will measure the total number of days spent admitted/not admitted to an acute care/rehabilitation facility as a proportion of their follow-up duration. This outcome will be assessed from hospital records and data linkage to medical records.
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Assessment method [2]
353108
0
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Timepoint [2]
353108
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12 Months post hospital discharge
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Secondary outcome [3]
353109
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Myocardial infarction: chest pain/discomfort associated with a rise and fall in serum troponin, or a new myocardial wall motion defect on echocardiography and consistent with the Universal Definition. This outcome will be assessed from hospital records and data linkage to medical records.
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Assessment method [3]
353109
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Timepoint [3]
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12 Months post hospital discharge
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Secondary outcome [4]
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Total resource utilisation over the length of follow-up will be obtained from hospital and centrally-collected SA Health data to provide estimates of in- and out-of-hospital costs.
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Assessment method [4]
355106
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Timepoint [4]
355106
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12 months post hospital discharge
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Secondary outcome [5]
355107
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Stroke: New onset neurological defect consistent with a single contiguous vascular territory, with supportive cerebral imaging. This outcome will be assessed from hospital records and data linkage to medical records.
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Assessment method [5]
355107
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Timepoint [5]
355107
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12 months post hospital discharge
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Secondary outcome [6]
355108
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Cardiovascular Hospitalisation including; coronary revascularization (PCI or CABG); cerebrovascular accidents with supportive cerebral imaging; atrial or ventricular cardiac arrhythmias; CCF without myocardial infarction; peripheral vascular revascularization; unstable angina, reoperation for surgical bleeding; surgical wound infection; pericardial effusion; and valvular dysfunction as documented by a hospital discharge summary or diagnosis-related group report.
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Assessment method [6]
355108
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Timepoint [6]
355108
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12 months post hospital discharge
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Eligibility
Key inclusion criteria
1. Primary diagnosis of heart failure (HFREF or HFPEF) for whom transition of care nursing support is planned.
2. Documented ability to interact with an electronic platform and confirmed regular access to device and internet/wifi.
3. Aged >18 years
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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
1. Inability or unwillingness to provide informed consent.
2. Dementia or significant cognitive impairment of any cause (eg including delirium, hypoxia) as per judgement of clinical care provider(s).
3. Life-expectancy of <12 months, as determined by treating specialist.
4. Inability to understand English or sufficient visual impairment such as would be unable to understand instructions within the platform, unless sufficient reliable access to help is available eg next of kin.
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Study design
Purpose of the study
Treatment
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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)
Allotment will be revealed by study staff (3 contacts- primary, secondary, and tertiary) to the study coordinator at the time of participant enrolment. Allocation will involve contacting the holder of the allocation schedule located at the central administration site.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation. An online randomisation generator will split the 100 participants into two groups via blocks of four, and double checked via review and data filtering of the resultant excel output
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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
This study is a pilot study and is not powered to address clinical outcomes. Nevertheless, the planned enrollment of 100 patients (50 per arm) will provide >90% power to detect a halving of HF specialist nurse time per patient, assuming a baseline of 3 hours (SD± 1.5hours), while providing an estimate of clinical safety (greater re-admission rates). These event rates will be used to inform the design of a definitive study.
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Recruitment
Recruitment status
Stopped early
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Data analysis
No data analysis planned
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
28/01/2019
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Actual
16/04/2019
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Date of last participant enrolment
Anticipated
16/04/2020
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Actual
25/07/2019
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Date of last data collection
Anticipated
16/04/2021
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Actual
25/07/2019
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Sample size
Target
100
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Accrual to date
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Final
7
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
12213
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Flinders Medical Centre - Bedford Park
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Recruitment postcode(s) [1]
24392
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5042 - Bedford Park
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Funding & Sponsors
Funding source category [1]
300981
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Commercial sector/Industry
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Name [1]
300981
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Personify Care
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Address [1]
300981
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Ground Floor, 10 Pulteney Street, Adelaide, South Australia, 5000
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Country [1]
300981
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Australia
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Funding source category [2]
300983
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Government body
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Name [2]
300983
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Australian Government Department of Industry, Innovation and Science
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Address [2]
300983
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10 Binara Street, Canberra, ACT, 2601
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Country [2]
300983
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Australia
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Primary sponsor type
University
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Name
Flinders University of South Australia
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Address
Sturt Road, Bedford Park, South Australia 5042
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Country
Australia
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Secondary sponsor category [1]
300565
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Hospital
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Name [1]
300565
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Flinders Medical Centre
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Address [1]
300565
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1 Flinders Drive, Bedford Park, South Australia 5042
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Country [1]
300565
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Australia
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Secondary sponsor category [2]
300567
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Government body
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Name [2]
300567
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SA Health
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Address [2]
300567
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Citi Centre Building, 11 Hindmarsh Square, Adelaide South Australia 5000
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Country [2]
300567
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Australia
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Other collaborator category [1]
280399
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Commercial sector/Industry
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Name [1]
280399
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Personify Care
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Address [1]
280399
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Ground Floor, 10 Pulteney Street, Adelaide, South Australia, 5000
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Country [1]
280399
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301743
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Southern Adelaide Clinical Human Research Ethics Committee
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Ethics committee address [1]
301743
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Flat 6 The Flats 1 Flinders Drive Bedford Park SA 5042
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Ethics committee country [1]
301743
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Australia
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Date submitted for ethics approval [1]
301743
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14/12/2018
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Approval date [1]
301743
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07/01/2019
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Ethics approval number [1]
301743
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HREC/19/SAC/1
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Summary
Brief summary
This research proposal will explore technologies to efficiently enhance clinical decision-making and provide interventions to the deteriorating heart failure patient at an earlier time point than standard care. It will determine if an alternate design of follow-up care utilising the “Personify Care” clinical platform can demonstrate efficiencies and in doing so decrease the substantial burden on this area of health service.
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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
87962
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Prof Derek Chew
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Address
87962
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Flinders Medical Centre, 1 Flinders Drive, Bedford Park 5042 South Australia
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Country
87962
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Australia
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Phone
87962
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+61 884042001
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Fax
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Email
87962
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[email protected]
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Contact person for public queries
Name
87963
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Dr Erin Morton
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Address
87963
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Flinders Medical Centre- Cardiology
Level 6, Rm 6R347
1 Flinders Drive Bedford Park SA 5042
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Country
87963
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Australia
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Phone
87963
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+61 8 82045836
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Fax
87963
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Email
87963
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[email protected]
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Contact person for scientific queries
Name
87964
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Dr Erin Morton
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Address
87964
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Flinders Medical Centre- Cardiology
Level 6, Rm 6R347
1 Flinders Drive Bedford Park SA 5042
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Country
87964
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Australia
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Phone
87964
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+61 8 82045836
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Fax
87964
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Email
87964
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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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