NCT04614428: RESILIENCE

Improving Outcomes in Patients With Cardiovascular Seasonality

Completed NA Last updated 27 March 2024

What this trial tests

NA trial testing RESILIENCE Program in Cardiovascular Diseases in 203 participants. Completed in 28 July 2023.

Timeline

25 November 2020

Primary endpoint
28 July 2023

28 July 2023

Quick facts

Lead sponsor	Sheila Patel
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	203
Start date	25 November 2020
Primary completion	28 July 2023
Estimated completion	28 July 2023
Sites	1 location across Australia

Drugs / interventions tested

• RESILIENCE Program

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

Sheila Patel

Who can join

18 and older, any sex, with Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vulnerability to environmental and climatic health provocations among women and men hospitalized with chronic heart disease: insights from the RESILIENCE TRIAL cohort.
   Stewart S, Patel SK, Lancefield TF, Rodrigues TS, et al · · 2024 · cited 3× · PMID 37625011 · DOI 10.1093/eurjcn/zvad076
2. Promoting resilience to weather-related and seasonal provocations to health in people with multimorbid heart disease: a prospective pragmatic, randomised trial.
   Stewart S, Patel SK, Lancefield TF, Sampaio Rodrigues T, et al · · 2025 · cited 1× · PMID 40556316 · DOI 10.5694/mja2.52699