Improving Outcomes in Patients With Cardiovascular Seasonality

NCT04614428 | Completed DMC

• 1 other identifier: CT19026
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Days-alive-out-of-hospital (DAOH)

  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".

  12-months (minimum) post randomisation to study census (July 2023)

Secondary Outcomes (3)

• Overall pattern of hospitalization

  12-months (minimum) post randomisation to study census

• Number of community care visits

  12-months (minimum) post randomisation to study census

• Healthcare costs

  12-months (minimum) post randomisation to study census

Study Arms (2)

Standard Care Group

NO INTERVENTION

Participants will receive the standard care provided by their institution.

RESILIENCE Program group

ACTIVE COMPARATOR

Participants will receive the RESILIENCE Program on top of the standard care provided by their institution.

Behavioral: RESILIENCE Program

Interventions

RESILIENCE Program BEHAVIORAL

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.

RESILIENCE Program group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual aged 18 years and over.
• 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
• Multimorbidity (defined as two or more chronic conditions requiring active treatment/management).
• A planned discharge to home within a 10km radius of the hospital.

You may not qualify if:

• Living in residential aged care
• Terminal illness and/or unable to give informed consent
• Died during index admission

Sponsors & Collaborators

• Sheila Patel: lead
• University of Melbourne: collaborator

Study Sites (1)

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Related Publications (2)

• Stewart S, Patel SK, Lancefield TF, Sampaio Rodrigues T, Doumtsis N, Moini N, Harley A, Vaughan-Fowler ER, Chan YK, Chen A, Chye D, Liew DF, McMaster C, Ramchand J, Yates PA, Kwong JC, McDonald CF, Burrell LM. Promoting resilience to weather-related and seasonal provocations to health in people with multimorbid heart disease: a prospective pragmatic, randomised trial. Med J Aust. 2025 Jul 21;223(2):77-84. doi: 10.5694/mja2.52699. Epub 2025 Jun 24.

  PMID: 40556316 DERIVED

• Stewart S, Patel SK, Lancefield TF, Rodrigues TS, Doumtsis N, Jess A, Vaughan-Fowler ER, Chan YK, Ramchand J, Yates PA, Kwong JC, McDonald CF, Burrell LM. Vulnerability to environmental and climatic health provocations among women and men hospitalized with chronic heart disease: insights from the RESILIENCE TRIAL cohort. Eur J Cardiovasc Nurs. 2024 Apr 12;23(3):278-286. doi: 10.1093/eurjcn/zvad076.

  PMID: 37625011 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Louise M Burrell, MD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The people assessing the outcomes will be masked
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Research Fellow

Model Details: Randomised control trial of two parallel groups; 1. Standard Care 2. Standard Care + RESILIENCE Program

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 4, 2020
• Study Start: November 25, 2020
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning following main results publication; no end date determined
• Access Criteria: Case-by-case basis at the discretion of the Primary Sponsor and RESILIENCE TRIAL Investigators and provide a methodologically sound proposal.

Locations

AU (1)