- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07805811
Testing Heart Failure Resilience Intervention for Caregivers (HEROIC) in Advanced Heart Failure
2026년 9월 1일 업데이트: Johns Hopkins University
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).
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
500
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Martha Abshire Saylor, Principal Investigator, PhD, RN
- 전화번호: HEROIC phone number
- 이메일: mabshir1@jhu.edu
연구 연락처 백업
- 이름: Meagan Clemence, Study Coordinator, M.Ed
연구 장소
-
-
Colorado
-
Denver, Colorado, 미국, 80217
- University of Colorado Anschutz
-
연락하다:
- Colleen McIlvennan,, PhD, DNP, ANP
- 전화번호: 920-540-0809
- 이메일: Colleen.McIlvennan@cuanschutz.edu
-
-
Maryland
-
Baltimore, Maryland, 미국, 21205
- Johns Hopkins University, School of Nursing
-
연락하다:
- Martha Abshire Saylor, PhD
- 전화번호: 443-340-6201
- 이메일: mabshir1@jhu.edu
-
수석 연구원:
- Martha Abshire Saylor, PhD
-
부수사관:
- Colleen McIlvennan, PhD, DNP, ANP
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
Exclusion Criteria:
- Patients and caregivers who screen positive for severe cognitive impairment Telephone Interview for Cognitive Screening (TICS-M) will be excluded.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: HEROIC program
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).
|
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).
다른 이름들:
|
|
활성 비교기: Control condition
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 .
|
The control group will receive:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mental Health (caregiver) as assessed by the Short Form Health Survey (SF-36)
기간: 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.
|
12 weeks
|
|
Health-related quality of Life (patient) as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
기간: 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.
|
12 weeks
|
|
Number of unplanned acute care (patient) visits
기간: 1 year
|
number of unplanned hospitalization, emergency room visit, urgent care and unscheduled/same-day visits
|
1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Caregiver burden as assessed by Zarit Burden Interview
기간: 12 weeks
|
Zarit Burden Interview, 13 item version.
Scores range from 0-48 with higher scores indicating worse burden.
|
12 weeks
|
|
Self-efficacy (caregiver) assessed by Coping Self-Efficacy Scale (CSE)
기간: 12 weeks
|
Coping Self-efficacy.
13 items.
Scores range from 0-130 with higher scores indicating better self-efficacy.
|
12 weeks
|
|
Self-care (patient) as assessed by the Heart Failure Self-Care Index
기간: 12 weeks
|
Heart Failure Self-Care Index, version 8.0, 23 items.
The Heart Failure Self-Care Index uses three separate subscales scored and standardized on a 0 to 100 scale, where 70 or higher indicates adequate self-care.
|
12 weeks
|
|
Palliative Care Needs as assessed by the Integrated Palliative Outcomes Scale (iPOS)
기간: 12 weeks
|
Integrated Palliative Outcomes Scale (iPOS), 10 items.
Scores range from 0-40 with higher scores indicating higher unmet needs.
|
12 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Martha Abshire Saylor, PhD, RN, Johns Hopkins University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Abshire Saylor M, Pavlovic NV, DeGroot L, Jajodia A, Hladek MD, Perrin N, Wolff J, Davidson PM, Szanton S. Strengths-building through life purpose, self-care goal setting and social support: Study protocol for Caregiver Support. Contemp Clin Trials Commun. 2022 May 5;28:100917. doi: 10.1016/j.conctc.2022.100917. eCollection 2022 Aug.
- Abshire Saylor M, Clair CA, Curriero S, DeGroot L, Nelson K, Pavlovic N, Taylor J, Gallo JJ, Szanton S. Analysis of action planning, achievement and life purpose statements in an intervention to support caregivers of persons with heart failure. Heart Lung. 2023 Sep-Oct;61:8-15. doi: 10.1016/j.hrtlng.2023.04.002. Epub 2023 Apr 12.
- Abshire Saylor M, Pavlovic N, DeGroot L, Peeler A, Nelson KE, Perrin N, Gilotra NA, Wolff JL, Davidson PM, Szanton SL. Feasibility of a Multi-Component Strengths-Building Intervention for Caregivers of Persons With Heart Failure. J Appl Gerontol. 2023 Dec;42(12):2371-2382. doi: 10.1177/07334648231191595. Epub 2023 Sep 14.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2027년 1월 4일
기본 완료 (추정된)
2030년 11월 30일
연구 완료 (추정된)
2031년 3월 31일
연구 등록 날짜
최초 제출
2026년 9월 1일
QC 기준을 충족하는 최초 제출
2026년 9월 1일
처음 게시됨 (실제)
2026년 9월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 1일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- IRB00568390
- 1R01HL183346 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
The scientific data and metadata generated by this project will be archived in a publicly accessible repository that meets recognized standards for data sharing and preservation.
The investigators will deposit the data and metadata in open Inter-university Consortium for Political and Social Research (ICPSR) data repository.
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .