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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

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)
Timepoint [1] 0 0
12-months (minimum) post randomisation to study census (July 2023)
Secondary outcome [1] 0 0
Overall pattern of hospitalization
Timepoint [1] 0 0
12-months (minimum) post randomisation to study census
Secondary outcome [2] 0 0
Number of community care visits
Timepoint [2] 0 0
12-months (minimum) post randomisation to study census
Secondary outcome [3] 0 0
Healthcare costs
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
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
Beginning following main results publication; no end date determined
Available to whom?
Case-by-case basis at the discretion of the Primary Sponsor and RESILIENCE TRIAL Investigators and provide a methodologically sound proposal.
Available for what types of analyses?
How or where can data be obtained?


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