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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
Date last updated
27/03/2024

Titles & IDs
Public title
Improving Outcomes in Patients With Cardiovascular Seasonality
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
Secondary ID [1] 0 0
CT19026
Universal Trial Number (UTN)
Trial acronym
RESILIENCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Days-alive-out-of-hospital (DAOH)
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".
Timepoint [1] 0 0
12-months (minimum) post randomisation to study census (July 2023)
Secondary outcome [1] 0 0
Overall pattern of hospitalization
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.
Timepoint [1] 0 0
12-months (minimum) post randomisation to study census
Secondary outcome [2] 0 0
Number of community care visits
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.
Timepoint [2] 0 0
12-months (minimum) post randomisation to study census
Secondary outcome [3] 0 0
Healthcare costs
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.
Timepoint [3] 0 0
12-months (minimum) post randomisation to study census

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Living in residential aged care
* Terminal illness and/or unable to give informed consent
* Died during index admission

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/07/2023
Sample size
Target
Accrual to date
Final
203
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg

Funding & Sponsors
Primary sponsor type
Government body
Name
Sheila Patel
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Louise M Burrell, MD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


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