Supporting Health in Veterans With Heart Failure
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: Care-HF.
- Кому может быть актуально
- Состояния в реестре: Heart Failure. Базовые параметры: от 18 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
Supporting Physical & Mental Health in Rural Veterans With Heart Failure (CARE-HF)
Обзор
This study will test the effectiveness of a culturally-sensitive, telephone-based, tailored problem-solving intervention to improve physical and mental health in Veterans with heart failure (HF). Veterans will be recruited from VA clinics throughout the United States. As a component of this study, Veterans will partner with a registered nurse for a 12-week telehealth program that includes 8 telephone sessions. Follow-up data will be collected at 3-months (post intervention) and 6-, 12-, and 18-months to examine sustainability of intervention effect.
Подробное описание
The long-term goal of this research is to support physical and mental health of Veterans with heart failure and enrich rehabilitation and independent living by enhancing disease self-management and coping processes in the home.
Study objectives include: (1) Evaluate the feasibility of recruitment and enrollment processes, attrition, and program acceptability in a sample of Veterans with HF; (2) Evaluate program effectiveness on study outcomes (i.e., self-care, symptoms, depression, anxiety, quality of life, stress, resilience, coping, and healthcare utilization); and (3) examine the sustainability of intervention effect.
This study will be guided by quantitative inquiry and include a single-group, repeated measures design. A sample size of 100 participants is desired based on a power analysis for repeated measures ANOVA with 5 time points, alpha level of .05, a medium effect size (f = 0.25), and 80% power, plus oversampling for potential attrition (20%). Following verbal informed consent via telephone, all participants will complete baseline data collection which will include a Sociodemographic and Clinical Survey, the Interpersonal Support Evaluation List - 12 (ISEL), the Social Problem-Solving Inventory Revised-Short (SPSIRs), the Self-care of Heart Failure Index (SCHFI, v 7.2), the Heart Failure Symptom Survey (HFSS), the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder (GAD) scale, the Minnesota Living with Heart Failure Questionnaire (MLHFQ), the Perceived Stress Scale (PSS), the 5x5 Resilience Scale, the Brief COPE, and a healthcare utilization survey.
All participants will participate in a tailored problem-solving intervention designed to help manage heart failure-related problems experienced in the home over 12 weeks (Weeks 1-4, 6, 8, 10, 12). Follow-up data collection will occur at 3-months (post-intervention) and 6-, 12-, and 18-months. Quantitative data on study variables will be collected using the following self-report surveys: SPSIRs, SCHFI, HFSS, PHQ-9, GAD, MLHFQ, PSS, 5x5 Resilience scale, Brief COPE, and healthcare utilization. All data will be collected by a trained research assistant who will collect study data over the telephone and mark participants answers on a computerized data spreadsheet. Possible treatment effectiveness on heart failure self-care, heart failure symptoms, healthcare utilization, depression, anxiety, quality of life, stress, resilience, coping, and differences among subgroups over the study period will be examined using multilevel modeling.
Вмешательства
- Поведенческое Care-HF
Participants will be trained to use a 5-step problem-solving process based on the Theory of Social Problem-Solving (TSPS) to manage HF-related problems over 12-weeks. The core belief of TSPS is effective problem-solving requires a positive problem orientation (i.e., viewing problems as a challenge versus a threat) and elicits rational problem-solving versus avoidance or impulsivity/carelessness. Problem-solving follows from a positive problem orientation and involves accurate problem identificat
Первичные конечные точки
- Heart Failure Self-care [Срок оценки: baseline]
- Heart Failure Self-care [Срок оценки: 3-months]
- Heart Failure Self-care [Срок оценки: 6-months]
- Heart Failure Self-care [Срок оценки: 12-months]
- Heart Failure Self-care [Срок оценки: 18-months]
- Heart Failure Symptoms [Срок оценки: baseline]
- Heart Failure Symptoms [Срок оценки: 3-months]
- Heart Failure Symptoms [Срок оценки: 6-months]
- Heart Failure Symptoms [Срок оценки: 12-months]
- Heart Failure Symptoms [Срок оценки: 18-months]
Вторичные конечные точки (12)
- Health Related Quality of Life [Срок оценки: baseline]
- Health Related Quality of Life [Срок оценки: 3-months]
- Health Related Quality of Life [Срок оценки: 6-months]
- Health Related Quality of Life [Срок оценки: 12-months]
- Health Related Quality of Life [Срок оценки: 18-months]
- Healthcare Utilization [Срок оценки: baseline]
- Healthcare Utilization [Срок оценки: 3-months]
- Healthcare Utilization [Срок оценки: 6-months]
- Healthcare Utilization [Срок оценки: 12-months]
- Healthcare Utilization [Срок оценки: 18-months]
- Stress [Срок оценки: baseline]
- Stress [Срок оценки: 3-months]
Критерии участия
Критерии включения
- Age 18 years of age or older
- US Veteran
- Diagnosed with heart failure (reduced or preserved ejection fraction)
- Able to read, speak, and understand English
- Reliable telephone access
Критерии исключения
- History of cognitive dysfunction
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 4 центра
- VA Clinic - Gainesville — Gainesville
- VA Clinic - Togus — Togus
- VA Clinic - Durham — Durham
- VA Clinic - Providence — Providence
Публикации
- Graven LJ, Abbott L, Hodgkins JV, Ledermann T, Howren MB. Supporting Physical and Mental Health in Rural Veterans Living With Heart Failure: Protocol for a Nurse-Led Telephone Intervention Study. JMIR Res Protoc. 2025 Mar 26;14:e63498. doi: 10.2196/63498. PMID 40138689
Идентификаторы
NCT: NCT05839067 · 00003764