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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04614428
Registration number
NCT04614428
Ethics application status
Date submitted
29/10/2020
Date registered
4/11/2020
Date last updated
27/03/2024
Titles & IDs
Public title
Improving Outcomes in Patients With Cardiovascular Seasonality
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Scientific title
Tailored, Interventional Health Care Program Designed to Address Seasonal Vulnerability in Patients With Chronic Heart Disease and Multimorbidity: the REsilience to Seasonal ILlness and Increased Emergency admissioNs CarE (RESILIENCE) Trial
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Secondary ID [1]
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CT19026
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Universal Trial Number (UTN)
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Trial acronym
RESILIENCE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - RESILIENCE Program
No Intervention: Standard Care Group - Participants will receive the standard care provided by their institution.
Active Comparator: RESILIENCE Program group - Participants will receive the RESILIENCE Program on top of the standard care provided by their institution.
Behaviour: RESILIENCE Program
In addition to the standard care participants would normally receive (including exposure to any standard hospital avoidance programs), the 150 participants assigned to the RESILIENCE Program group will receive a combination of strategies designed to promote seasonal resilience.
This includes profiling of seasonal vulnerability; a 60-80 minute home visit by the RESILIENCE Nurse to assess physiological status, behavioural adaptations, environment, and modulating factors; a dedicated RESILIENCE Clinic with a dedicated RESILIENCE physician to develop a long-term plan to help promote/maintain seasonal resilience and; a structured follow-up over the next 12 months to monitor and adjust the participant's status and management from a seasonal perspective.
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Days-alive-out-of-hospital (DAOH)
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Assessment method [1]
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Defined as the proportion of maximal days follow-up where the study participant was not admitted to hospital and alive. DAOH data will be collected from hospital records. During minimum 12-month follow-up, the pre-specified threshold for a clinically significant effect in favour of the RESILIENCE Program is a 10% increase in DOAH compared to "standard care".
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Timepoint [1]
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12-months (minimum) post randomisation to study census (July 2023)
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Secondary outcome [1]
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Overall pattern of hospitalization
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Assessment method [1]
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Frequency and causes of unplanned hospitalization plus Emergency Service and out-patient visits and related bed-days will be determined from hospital medical records.
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Timepoint [1]
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12-months (minimum) post randomisation to study census
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Secondary outcome [2]
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Number of community care visits
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Assessment method [2]
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Including visits to the General Practitioner, pharmacist consultations, allied health services, supported-care and pharmacotherapy determined through the RESILIENCE Clinic.
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Timepoint [2]
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12-months (minimum) post randomisation to study census
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Secondary outcome [3]
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Healthcare costs
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Assessment method [3]
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Healthcare costs assessed for extending days-alive-out-of-hospital, transport and other costs due to clinic attendance as well as co-payments for clinic visits and drug therapy.
All expenditure will be standardized for the reporting year and an extrapolation of the potential impact of the RESILIENCE Program from the perspective of the Australian health care system will be made. QALYs will be calculated from survival and the AQoL-8D as the primary outcome for cost-utility analysis.
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Timepoint [3]
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12-months (minimum) post randomisation to study census
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Eligibility
Key inclusion criteria
1. Individual aged 18 years and over.
2. Admitted to hospital due to a medical emergency for any reason but with a chronic form
of heart disease (i.e. including. coronary artery disease, atrial fibrillation and/or
heart failure) requiring treatment
3. Multimorbidity (defined as two or more chronic conditions requiring active
treatment/management).
4. A planned discharge to home within a 10km radius of the hospital.
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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
- Living in residential aged care
- Terminal illness and/or unable to give informed consent
- Died during index admission
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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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
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/11/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/07/2023
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Sample size
Target
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Accrual to date
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Final
203
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Heidelberg
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Funding & Sponsors
Primary sponsor type
Other
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Name
Sheila Patel
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Melbourne
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Despite a range of evidence-based programs to identify high-risk patients and apply
strategies to keep them out of hospital, a growing number of cases are "resistant" to such
programs. These "seasonal frequent flyers" routinely overwhelm hospital services. The
investigators have identified vulnerability to provocation of seasonal and acute weather
changes ("seasonality") as a major driver of preventable/costly hospitalisations in typically
older patients with heart disease and multimorbidity subject to gold-standard care. From this
research the investigators developed the RESILIENCE Program which is tailored to each person
and designed to assist the participants to become more "resilient" to changes in the weather.
The overall aim of the RESILIENCE Trial is to demonstrate the cost-effectiveness of an
individually tailored, interventional health care program designed to address the
debilitating, costly and deadly phenomenon of seasonal vulnerability in a growing number of
individuals admitted to hospital with chronic heart disease and multimorbidity.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04614428
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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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Louise M Burrell, MD
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Address
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University of Melbourne
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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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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 scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04614428
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