INTEgRated Health CARE for Patients With Frailty and Heart Failure (INTERCARE-HF): Evaluation of an Innovation Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in symptom control and patient satisfaction
研究概览
简要总结
Frailty, an aging-related syndrome of physiological decline characterized by marked vulnerability to adverse health outcomes, has attracted increasing attention in cardiology due to the growing elderly population with heart failure. Frail patients are mainly excluded from large cardiovascular intervention studies, and clinical trials addressing frailty and showing an impact on treatment on symptom burden, quality of life and /or outcome has been requested in recent guidelines and consensus documents. The INTEgrRated health CARE for patients with severe frailty and Heart Failure (INTERCARE-HF) is a proof-of-concept study that aims to evaluate the effect of integrated healthcare services for heart failure patients with a severe level of frailty by establishing interdisciplinary and coordinated follow-up teams across the healthcare boundaries. These teams will assess the patient's needs, goals, and risk areas, conduct advance care planning, and develop individualized treatment and follow-up plans. An open-label, non-randomized intervention study aims to recruit 20 patients and heart failure and a clinical Frailty Score (CSF) >=5. A control-group (N=40) matched on age an clinical frailty scale score will be included. The overall hypothesis is that the intervention is feasible in routine clinical practice with favorable effects on quality of life, symptoms, caregiver distress, and healthcare service utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age >18 years old
- •Admitted to hospital with heart failure with symptoms of decompensation including dyspnoea in NYHA class ≥ II, pulmonary congestion on chest x-ray and/or other signs like oedema or positive rales on auscultation and elevated NT-proBNP concentrations at screening
- •Clinical Frailty Score ≥5
- •Signed informed consent by patient and closest relatives* and expected cooperation according to the protocol, ICH/GCP and national/local regulations
- •Although we preferably will recruit both patients and their relatives, participation from the next-of-kin will not be an exclusion criterium.
排除标准
- •Inability to comply with all study requirements, due to major co-morbidities or psychosocial issues, or a history of noncompliance, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures.
- •Not being able to understand Norwegian.
- •Permanent nursing home and estimated to stay alive for less than 6 months
结局指标
主要结局
Changes in symptom control and patient satisfaction
时间窗: From baseline to weeks 6, 12, and 52
Between-group differences in The Edmonton Symptom Assessment System revised (ESAS-r) scores
Changes in health-related quality of life
时间窗: From baseline to weeks 6, 12, and 52
Between-group differences in Kansas City Cardiomyopathy Questionnaire 12 scores
次要结局
- The number of days lost due to unplanned hospital re-admissions for specific diagnosis during the follow-up(From baseline to weeks 6, 12, and 52)
- Total number of days lost due to unplanned hospital re-admissions during the follow-up(From baseline to weeks 6, 12, and 52)
- Changes in caregiver distress(From baseline to weeks 6, 12, and 52)
- Total number of hospitalizations(From baseline to weeks 6, 12, and 52)