- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07805811
Testing Heart Failure Resilience Intervention for Caregivers (HEROIC) in Advanced Heart Failure
1 września 2026 zaktualizowane przez: 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).
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
500
Faza
- Faza 2
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Martha Abshire Saylor, Principal Investigator, PhD, RN
- Numer telefonu: HEROIC phone number
- E-mail: mabshir1@jhu.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Meagan Clemence, Study Coordinator, M.Ed
Lokalizacje studiów
-
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Colorado
-
Denver, Colorado, Stany Zjednoczone, 80217
- University of Colorado Anschutz
-
Kontakt:
- Colleen McIlvennan,, PhD, DNP, ANP
- Numer telefonu: 920-540-0809
- E-mail: Colleen.McIlvennan@cuanschutz.edu
-
-
Maryland
-
Baltimore, Maryland, Stany Zjednoczone, 21205
- Johns Hopkins University, School of Nursing
-
Kontakt:
- Martha Abshire Saylor, PhD
- Numer telefonu: 443-340-6201
- E-mail: mabshir1@jhu.edu
-
Główny śledczy:
- Martha Abshire Saylor, PhD
-
Pod-śledczy:
- Colleen McIlvennan, PhD, DNP, ANP
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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).
Inne nazwy:
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Aktywny komparator: 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:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Mental Health (caregiver) as assessed by the Short Form Health Survey (SF-36)
Ramy czasowe: 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)
Ramy czasowe: 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
|
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Number of unplanned acute care (patient) visits
Ramy czasowe: 1 year
|
number of unplanned hospitalization, emergency room visit, urgent care and unscheduled/same-day visits
|
1 year
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Caregiver burden as assessed by Zarit Burden Interview
Ramy czasowe: 12 weeks
|
Zarit Burden Interview, 13 item version.
Scores range from 0-48 with higher scores indicating worse burden.
|
12 weeks
|
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Self-efficacy (caregiver) assessed by Coping Self-Efficacy Scale (CSE)
Ramy czasowe: 12 weeks
|
Coping Self-efficacy.
13 items.
Scores range from 0-130 with higher scores indicating better self-efficacy.
|
12 weeks
|
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Self-care (patient) as assessed by the Heart Failure Self-Care Index
Ramy czasowe: 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.
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12 weeks
|
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Palliative Care Needs as assessed by the Integrated Palliative Outcomes Scale (iPOS)
Ramy czasowe: 12 weeks
|
Integrated Palliative Outcomes Scale (iPOS), 10 items.
Scores range from 0-40 with higher scores indicating higher unmet needs.
|
12 weeks
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Martha Abshire Saylor, PhD, RN, Johns Hopkins University
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
4 stycznia 2027
Zakończenie podstawowe (Szacowany)
30 listopada 2030
Ukończenie studiów (Szacowany)
31 marca 2031
Daty rejestracji na studia
Pierwszy przesłany
1 września 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
1 września 2026
Pierwszy wysłany (Rzeczywisty)
4 września 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
4 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
1 września 2026
Ostatnia weryfikacja
1 września 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB00568390
- 1R01HL183346 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
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.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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