Sustaining Home Heart Failure Palliative Care in Rural Appalachia
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: HF-FamPALhomeCARE.
- Кому может быть актуально
- Состояния в реестре: Heart Failure NYHA Class III, Heart Failure NYHA Class IV. Базовые параметры: 45 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Sustaining Home Palliative Care for Patients With Heart Failure (HF) and Their Family Caregivers in Rural Appalachia: A Mixed Methods Randomized Clinical Trial (RCT).
Обзор
The aim of this mixed methods randomized controlled trial is to test the integrated nurse-led intervention bundle for family home care management of end-stage heart failure and palliative care in rural Appalachia. This intervention bundle is designed to address rural disparities in access to health care, with the help of the faith-based nurses and local volunteer visiting neighbors.
Подробное описание
This study uses a randomized control trial (RCT) design to test the integrated nurse-led intervention bundle of home palliative care intervention (HF-FamPALhomeCARE) for patients with heart failure (HF) and their family caregivers. (104 patient-family caregiver dyads).
The researcher will compare HF-FamPALhomeCARE to the standard control group to see if the participants in HF-FamPALhomeCARE group will report better health outcomes than the standard control group at the completion of the study at 12 months.
Aim 1: Compared to the control group at 3, 6, 9 months, and 1-year follow-up:
Hypothesis 1a. The patients in the intervention group will have higher scores on HF-related health quality-of-life measure and on the World Health Organization (WHO) aging functional health well-being scale.
Hypothesis 1b. The family caregivers in the intervention group will have higher scores on the World Health Organization (WHO) aging functional health well-being scale.
Aim 2: Compared to the control group at 3, 6, 9 months, and 1-year follow-up:
Hypothesis 2a. The patients in the intervention group will have (a) lower depression and anxiety scores and (b) higher numbers of signed EOL advance directives.
Hypothesis 2b. The family caregivers in the intervention group will have (a) lower depression and anxiety scores, (b) lower home caregiving burden scores, and (c) improved home HF EOLPC preparedness and improved home palliative care scores.
All participants receive standard care, which is routine HF instruction from their care providers. The HF-FamPALhomeCARE group receives 5-session intervention includes 2 home visits, and 3 bi-weekly telephone calls on HF home EOLPC care. Three follow-up telephone calls will be provided at 3, 6, 9, and 12 months. Control subjects will receive the same HF home care information after 12-month. Data collection for both groups are conducted at baseline, 3, 6, 9, and 12 months.
Вмешательства
- Поведенческое HF-FamPALhomeCARE
Participants in HF-FamPALhomeCARE Intervention group receive standard care plus 2 home visits, 3 bi-weekly telephone call on HF home EOLPC care, and follow-up telephone calls at 3, 6, 9, and 12 months.
Первичные конечные точки
- Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [Срок оценки: Baseline]
- Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [Срок оценки: 3 Month Follow up]
- Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [Срок оценки: 6 Month Follow up]
- Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [Срок оценки: 9 Month Follow up]
- Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [Срок оценки: 12 Month Follow Up]
- Patient--World Health Organization Quality of life Questionnaire [Срок оценки: Baseline]
- Patient--World Health Organization Quality of life Questionnaire [Срок оценки: 3 Month Follow up]
- Patient--World Health Organization Quality of life Questionnaire [Срок оценки: 6 Month Follow up]
- Patient--World Health Organization Quality of life Questionnaire [Срок оценки: 9 Month Follow up]
- Patient--World Health Organization Quality of life Questionnaire [Срок оценки: 12 Month Follow up]
Вторичные конечные точки (12)
- Patient--Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline]
- Patient--Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: 3 Month Follow up]
- Patient--Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: 6 Month Follow up]
- Patient--Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: 9 Month Follow up]
- Patient--Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: 12 Month Follow up]
- Caregiver--Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline]
- Caregiver--Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: 3 Month Follow up]
- Caregiver--Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: 6 Month Follow up]
- Caregiver--Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: 9 Month Follow up]
- Caregiver--Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: 12 Month Follow up]
- Patient--Generalized anxiety disorder (GAD-7) [Срок оценки: Baseline]
- Patient--Generalized anxiety disorder (GAD-7) [Срок оценки: 3 Month Follow up]
Критерии участия
Критерии включения
- Adult patients' age between 50 to 80 years with advanced HF (NYHA III or IV), diagnosed by physician
- Caregivers' age between 45 to 80 years.
- Alert and consent to participate
- Able to read and understand English
Критерии исключения
- Already received or are on a waiting list for a heart transplant or left ventricular assist device (LVAD)
- Diagnosed with a terminal illness or dementia, such as Alzheimer's disease
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- West Virginia University Hospital — Morgantown
Публикации
- Piamjariyakul U, Young S, Smothers A, Wen S, Navia RO, Sokos G, Hendrickson AE, Fink P, Niland D, Hottle M, Giolzetti AC, Smith CE. Study protocol of sustaining home palliative care for patients with Heart Failure (HF) and their family caregivers in rural Appalachia: a mixed methods randomized clinical trial. BMC Palliat Care. 2025 Mar 7;24(1):56. doi: 10.1186/s12904-025-01680-y. PMID 40055735
Идентификаторы
NCT: NCT06791850 · 2408021376 · R01NR021630