Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04614428 |
| Other study ID # |
CT19026 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 25, 2020 |
| Est. completion date |
July 28, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Austin Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
After informed written consent, a total of 203 participants (of an initially planned 300
participants prior to the COVID pandemic) had comprehensive sociodemographic and clinical
profiling to establish extent of multi-morbidity. Baseline demographic, lifestyle and medical
history profiling were also completed - including anthropometric measurements, and blood
pressure, handgrip strength test and sit-stand tests. The Montreal Cognitive Assessment,
depression, anxiety and quality of life questionnaires were also applied. Blood biochemistry
will be assessed for vitamin D, blood counts, thyroid and renal function, hemoglobin and
glycated hemoglobin levels.
After the initial profiling, 203 participants were randomized to standard care or the
RESILIENCE Program group and discharged alive to home.
In addition to the standard care participants would normally receive, the one in two
participants assigned to the RESILIENCE Program group will receive a structured follow-up
over the next 12 months to monitor and adjust the participant's status and management from a
seasonal perspective. These will include a combination of strategies designed to promote
seasonal resilience.
Specifically, this will include:
1. Profiling of the participants seasonal vulnerability: prior to hospital discharge,
participants will be clinically profiled and then fitted with an physiological monitor
(to measure heart rate, physical activity levels) at the point of hospital discharge.
2. Within 7-14 days after discharge a 60-80-minute home visit will be conducted by a
dedicated RESILIENCE Nurse to assess:
- Physiological Status: The physiological monitor will be collected for analysis at
this visit and blood pressure will be measured.
- Environment: A formal home environment assessment including presence/type of
heating and/or cooling equipment, air quality and any other factors that might
contribute to seasonal instability (e.g. lack of home insulation). Indoor versus
outdoor temperature and humidity will also be measured.
- Behaviour: Participants will be asked to describe the adaptive changes they make to
activity levels, diet, clothing and heating/cooling behaviours during winter versus
summer and acute weather events; with an immediate assessment relevant to ambient
weather conditions.
- Modulating Factors: The (socio-economic) capacity for the participant/family to
apply resources/funds to maintain thermoregulatory control (including clothing
choices and ability to pay power bills) throughout the year will be assessed;
alongside those personal factors/decisions that potentially determine how they
prioritize other forms of expenditure.
3. Participants with the capacity and/or preference for videoconferencing will be offered
"virtual/remote" attendance or a standard outpatient clinic appointment at the Austin
Hospital RESILIENCE Clinic with a dedicated RESILIENCE physician to develop a long-term
plan to help promote/maintain seasonal resilience. The clinic appointments will occur
with the individual at 21 days, 6 months and 12 months post hospital discharge.
At 12 months, the comprehensive socio-demographic and clinical profiling will be repeated in
the RESILIENCE Program group.
Due to the impact of the COVID epidemic (with extensive lockdowns in Melbourne, Victoria and
clinical restrictions at the Austin Hospital), a reduced study cohort was recruited (203 of
planned 300 eligible and randomised participants) with follow-up extended beyond 12 months to
(partially) restore study power to examine the potential impact of the study intervention on
the same health outcomes.
