Clinical trial NCT04614428: Improving Outcomes in Patients With Cardiovascular Seasonality
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Austin Health
Sponsor class: OTHER_GOV
Collaborators: name: University of Melbourne
First posted: 2020-11-04
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised control trial of two parallel groups;

1. Standard Care
2. Standard Care + RESILIENCE Program
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Days-alive-out-of-hospital (DAOH)
timeFrame: 12-months (minimum) post randomisation to study census (July 2023)
Secondary outcomes:
measure: Overall pattern of hospitalization
timeFrame: 12-months (minimum) post randomisation to study census
measure: Number of community care visits
timeFrame: 12-months (minimum) post randomisation to study census
measure: Healthcare costs
timeFrame: 12-months (minimum) post randomisation to study census
Other outcomes:
Locations:
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Louise M Burrell, MD
role: PRINCIPAL_INVESTIGATOR
References: