Testing Heart Failure Resilience Intervention for Caregivers (HEROIC) in Advanced Heart Failure
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Phase 2
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Martha Abshire Saylor, Principal Investigator, PhD, RN
- Telefonnummer: HEROIC phone number
- E-Mail: mabshir1@jhu.edu
Studieren Sie die Kontaktsicherung
- Name: Meagan Clemence, Study Coordinator, M.Ed
Studienorte
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Colorado
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Denver, Colorado, Vereinigte Staaten, 80217
- University of Colorado Anschutz
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Kontakt:
- Colleen McIlvennan,, PhD, DNP, ANP
- Telefonnummer: 920-540-0809
- E-Mail: Colleen.McIlvennan@cuanschutz.edu
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21205
- Johns Hopkins University, School of Nursing
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Kontakt:
- Martha Abshire Saylor, PhD
- Telefonnummer: 443-340-6201
- E-Mail: mabshir1@jhu.edu
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Hauptermittler:
- Martha Abshire Saylor, PhD
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Unterermittler:
- Colleen McIlvennan, PhD, DNP, ANP
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
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Experimental: 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).
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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).
Andere Namen:
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Aktiver 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 .
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The control group will receive:
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Mental Health (caregiver) as assessed by the Short Form Health Survey (SF-36)
Zeitfenster: 12 weeks
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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.
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12 weeks
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Health-related quality of Life (patient) as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Zeitfenster: 12 weeks
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Kansas City Cardiomyopathy Questionnaire (KCCQ), 12 item version.
Scoring is from 0 to 100 where higher scores indicate better health-related quality of life.
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12 weeks
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Number of unplanned acute care (patient) visits
Zeitfenster: 1 year
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number of unplanned hospitalization, emergency room visit, urgent care and unscheduled/same-day visits
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1 year
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Caregiver burden as assessed by Zarit Burden Interview
Zeitfenster: 12 weeks
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Zarit Burden Interview, 13 item version.
Scores range from 0-48 with higher scores indicating worse burden.
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12 weeks
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Self-efficacy (caregiver) assessed by Coping Self-Efficacy Scale (CSE)
Zeitfenster: 12 weeks
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Coping Self-efficacy.
13 items.
Scores range from 0-130 with higher scores indicating better self-efficacy.
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12 weeks
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Self-care (patient) as assessed by the Heart Failure Self-Care Index
Zeitfenster: 12 weeks
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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)
Zeitfenster: 12 weeks
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Integrated Palliative Outcomes Scale (iPOS), 10 items.
Scores range from 0-40 with higher scores indicating higher unmet needs.
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12 weeks
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Mitarbeiter
Mitarbeiter
Ermittler
Ermittler
- Hauptermittler: Martha Abshire Saylor, PhD, RN, Johns Hopkins University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- IRB00568390
- 1R01HL183346 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Art der unterstützenden IPD-Freigabeinformationen
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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