跳至主要内容
临床试验/NCT07805811
NCT07805811尚未招募2 期

Testing Heart Failure Resilience Intervention for Caregivers (HEROIC) in Advanced Heart Failure

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2027年1月4日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
500
试验地点
2
主要终点
Mental Health (caregiver) as assessed by the Short Form Health Survey (SF-36)

研究概览

简要总结

This study will test the mechanisms of a multi-component, nurse-led, primary palliative care intervention, HEart failure Resilience Intervention for Caregivers (HEROIC) to improve caregiver mental well-being, patient health-related quality of life and unplanned acute care in the setting of advanced heart failure. The investigators will conduct a multi-site, randomized controlled trial to test proposed mechanisms of action in a large sample (N=500) of persons with heart failure and the caregivers. The investigators will also examine variation in response to HEROIC components by heart failure subgroup (ventricular assist device, heart transplant or medically managed heart failure).

详细描述

Heart failure (HF) is a major source of suffering, the leading cause of death in the US (higher than dementia and cancer combined) and results in $108 billion annually in global health care costs to individuals, families and communities. Policies limiting reimbursement for HF readmissions increase strain on family caregivers to manage HF in the home with very little support. Despite advancements in guideline-directed medical therapies, HF patient outcomes are worse than the prior decade - including higher readmissions and mortality. Increased uptake of advanced HF surgical therapies including durable ventricular assist device and heart transplantation improve patient health-related quality of life (HRQOL) and survival but require high involvement of family caregivers. The impact of advanced HF care and policy falls on family caregivers who bear increased tasks and responsibilities over time while saving health systems over 7 billion per year. Caregiving for persons with HF, regardless of advanced therapies, is associated with worsening caregiver mental health, burden, stress, loss of social connections, disruptions to work, and increased financial strain. The HEart Failure Resilience Intervention for Caregivers (HEROIC) is a theory- and evidence-based primary palliative intervention including 5 individualized nurse-led sessions conducted over 10 weeks via video calls. HEROIC helps caregivers identify and address caregiving and palliative care needs for the patient, while also focusing on caregiver mental health, leveraging multi-level resilience resources: individual (goal-setting, self-care), community (social support, palliative/clinical, community) and existential (life purpose). The investigators now propose to conduct a mechanistic randomized controlled trial to test HEROIC mechanisms of action for caregivers (N=250) and persons with advanced HF for whom the caregivers provide care, including those treated medically, or with ventricular assist device or heart transplantation (N=250) in two health systems. Aim 1 focuses on caregiver self-efficacy and burden as mechanisms of action by which HEROIC improves caregiver mental health at 12 and maintenance at 24 weeks. Aim 2 focuses on patient mechanisms - increases in HF self-care and reductions in unmet palliative care needs as mediators of improvement in patient HRQOL at 12 and 24 weeks and unplanned acute care at 1 year. Aim 3 explores differences in mechanisms and response to intervention components by HF subgroup. The investigators will recruit a Patient and Family Advisory Council to guide the trial and intervention delivery. An exceptional study team with expertise in intersecting fields of research including HF, caregiving, and mixed methods research will guide the study. This innovative proposal directly responds to HF guidelines, policy initiatives and National Heart, Lung, and Blood Institute (NHLBI) strategic priorities, including Grant Notice "NOT-HL-23-117" Palliative Care in the Care Continuum, and will provide evidence of a powerful primary palliative care strategy to demonstrate how HEROIC works (mechanisms) so that it can be scaled and adapted across settings and populations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Caregiver Inclusion Criteria:
  • English or Spanish-speaking.
  • > 18 years old.
  • Supports at least one activity of daily living (ADL) or instrumental activity of daily living IADL) for the person with HF (care recipient).
  • Lives with the person with HF or visits regularly (e.g. weekly phone calls and visits at least once per month) to provide ADL/IADL support.
  • ≥5 on the Zarit Burden Interview
  • Patient Inclusion Criteria:
  • English or Spanish-speaking.
  • > 18 years old.
  • Reports needing help with at least one activity of daily living or instrumental activity of daily living.
  • Identifies a primary caregiver AND caregiver consents.
  • Diagnosed with heart failure. AND
  • If Medically managed, no Ventricular Assist Device (VAD) or Transplant (TX): Documentation of HF with preserved ejection fraction OR HF with reduced ejection fraction (LVEF<40%) OR Documented American College of Cardiology / American Heart Association (ACC/AHA) HF stage C or D (EMR) OR Documentation of New York Heart Association functional class II - IV (EMR)
  • If ventricular assist device: > 1 month since implant AND ambulatory/outpatient
  • If heart transplant: > 1 month since Heart Transplant (HTx) AND ambulatory/outpatient

排除标准

  • Patients and caregivers who screen positive for severe cognitive impairment Telephone Interview for Cognitive Screening (TICS-M) will be excluded.

研究组 & 干预措施

HEROIC program

Experimental

The HEart Failure Resilience Intervention for Caregivers (HEROIC) is a theory- and evidence-based primary palliative care intervention including 5 individualized nurse-led sessions conducted over 10 weeks via video calls. HEROIC helps caregivers identify and address caregiving and palliative care needs for the patient, while also focusing on caregiver mental health, leveraging multi-level resilience resources: individual (goal-setting, self-care), community (social support, palliative/clinical, community) and existential (life purpose).

干预措施: HEROIC program (Behavioral)

Control condition

Active Comparator

The control group will receive written educational materials related to Heart Failure (HF) management, home safety tips, and supportive resources. This control is selected to provide a comparative baseline that reflects typical care practices without the active intervention elements .

干预措施: Active Comparator Control 1 (Behavioral)

结局指标

主要结局

Mental Health (caregiver) as assessed by the Short Form Health Survey (SF-36)

时间窗: 12 weeks

Short Form Health Survey (SF-36), mental health composite score. The mental health composite score is an average of 4 out of 8 sub-scales. Scoring is 0 to 100, where higher scores indicate better mental health and fewer psychological distress symptoms.

Health-related quality of Life (patient) as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

时间窗: 12 weeks

Kansas City Cardiomyopathy Questionnaire (KCCQ), 12 item version. Scoring is from 0 to 100 where higher scores indicate better health-related quality of life.

Number of unplanned acute care (patient) visits

时间窗: 1 year

number of unplanned hospitalization, emergency room visit, urgent care and unscheduled/same-day visits

次要结局

  • Caregiver burden as assessed by Zarit Burden Interview(12 weeks)
  • Self-efficacy (caregiver) assessed by Coping Self-Efficacy Scale (CSE)(12 weeks)
  • Self-care (patient) as assessed by the Heart Failure Self-Care Index(12 weeks)
  • Palliative Care Needs as assessed by the Integrated Palliative Outcomes Scale (iPOS)(12 weeks)

研究者

发起方
Johns Hopkins University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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