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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sheila Patel
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- Days-alive-out-of-hospital (DAOH)
研究概览
简要总结
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.
详细描述
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:
- 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.
- Within 7-14 days after discharge a 60-80-minute home visit will be conducted by a dedicated RESILIENCE Nurse to assess:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The people assessing the outcomes will be masked
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Living in residential aged care
- •Terminal illness and/or unable to give informed consent
- •Died during index admission
结局指标
主要结局
Days-alive-out-of-hospital (DAOH)
时间窗: 12-months (minimum) post randomisation to study census (July 2023)
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".
次要结局
- Healthcare costs(12-months (minimum) post randomisation to study census)
- Number of community care visits(12-months (minimum) post randomisation to study census)
- Overall pattern of hospitalization(12-months (minimum) post randomisation to study census)
研究者
Sheila Patel
Senior Research Fellow
Austin Health