Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04614428
Registration number
NCT04614428
Ethics application status
Date submitted
29/10/2020
Date registered
4/11/2020
Titles & IDs
Public title
Improving Outcomes in Patients With Cardiovascular Seasonality
Query!
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
Query!
Secondary ID [1]
0
0
CT19026
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
RESILIENCE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
BEHAVIORAL - 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.
BEHAVIORAL: 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.
Query!
Intervention code [1]
0
0
BEHAVIORAL
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Days-alive-out-of-hospital (DAOH)
Query!
Assessment method [1]
0
0
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".
Query!
Timepoint [1]
0
0
12-months (minimum) post randomisation to study census (July 2023)
Query!
Secondary outcome [1]
0
0
Overall pattern of hospitalization
Query!
Assessment method [1]
0
0
Frequency and causes of unplanned hospitalization plus Emergency Service and out-patient visits and related bed-days will be determined from hospital medical records.
Query!
Timepoint [1]
0
0
12-months (minimum) post randomisation to study census
Query!
Secondary outcome [2]
0
0
Number of community care visits
Query!
Assessment method [2]
0
0
Including visits to the General Practitioner, pharmacist consultations, allied health services, supported-care and pharmacotherapy determined through the RESILIENCE Clinic.
Query!
Timepoint [2]
0
0
12-months (minimum) post randomisation to study census
Query!
Secondary outcome [3]
0
0
Healthcare costs
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
12-months (minimum) post randomisation to study census
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Living in residential aged care
* Terminal illness and/or unable to give informed consent
* Died during index admission
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
25/11/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
28/07/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
203
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Austin Health - Heidelberg
Query!
Recruitment postcode(s) [1]
0
0
3084 - Heidelberg
Query!
Funding & Sponsors
Primary sponsor type
Government body
Query!
Name
Sheila Patel
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
University of Melbourne
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04614428
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Louise M Burrell, MD
Query!
Address
0
0
University of Melbourne
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Trial data will be disseminated in the form of a publication to a relevant clinical journal and presentation at appropriate scientific conferences. Individual participant data that underlie the published results, may be shared on request by the RESILIENCE TRIAL Investigators at the completion of the trial and reporting of the endpoints.
Supporting document/s available: Study protocol
Query!
When will data be available (start and end dates)?
Beginning following main results publication; no end date determined
Query!
Available to whom?
Case-by-case basis at the discretion of the Primary Sponsor and RESILIENCE TRIAL Investigators and provide a methodologically sound proposal.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04614428