A Cardiac Disease Quality of Life Study
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: QOL Survey.
- Кому может быть актуально
- Состояния в реестре: Hypertrophic Obstructive Cardiomyopathy, Thoracic Aortic Dilatation, Heart Disease Caused by Ionising Radiation, Quality of Life. Базовые параметры: 18 лет — 70 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
A Prospective Study to Assess Multi-Domain Patient-Reported Cardiac Quality of Life in Adults With Hypertrophic Cardiomyopathy, Thoracic Aortopathy, and Radiation-Induced Heart Disease: UPLIFT
Обзор
A prospective, longitudinal, non-comparator, non-randomized observational cohort study to assess the quality of life in adult patients affected by hypertrophic cardiomyopathy and thoracic aortic dilatations who are not amenable to surgery, as well as those affected radiation-induced cardiac disease caused by radiation therapy.
Подробное описание
While physicians and patients may be aware of the physical limitations that result from a diagnosis of hypertrophic cardiomyopathy (HCM), thoracic aortic dilatation (TAD) or radiation-induced heart disease (RIHD), there is little research on the impact on quality of life from the limitations imposed with these diagnosis. This study aims to address these unknowns in patients with HCM or TAD as well as radiation-induced heart disease in first-time patients at the Cleveland Clinic. Knowledge gained from this study will provide us the ability for better management of the chronic impacts of the disease by identifying potential risk factors of low quality of life or changes in quality of life over time.
This is a prospective, longitudinal, non-comparator, non-randomized survey study describing QOL outcomes for patients with HCM, TAD, or RIHD. Patients being seen for the first time at the Cleveland Clinic for cardiac disease with no previous or scheduled surgery for HCM or TAD will electronically complete a Cardiac Quality of Life Survey at 3 time points (baseline, 3 month \& 9 month). The Cardiac Quality of Life Survey measures the participant's health status in five domains - global, physical, emotional, social, and spiritual - as well as self-efficacy and resilience.
Вмешательства
- Другое QOL Survey
The Cardiac Quality of Life (QOL) survey measures health status in five domains: global, physical, emotional, social, and spiritual health. It also includes questions that assess self-efficacy and resilience. The global section asks about your overall quality of life and satisfaction with health. The physical section asks about symptoms and difficulty performing day-to-day tasks. The emotional section asks about depression, anxiety, and stress. The social section asks about social support and re
Первичные конечные точки
- Global domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline. [Срок оценки: 9 months after baseline visit]
- Physical domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline [Срок оценки: 9 months after baseline visit]
- Emotional domain of Cardiac Quality of Life Survey assessed 3 months after baseline as compared to baseline. [Срок оценки: 9 months after baseline visit]
- Social domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline. [Срок оценки: 9 months after baseline visit]
- Spiritual domain of quality of life assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic. [Срок оценки: 9 months after baseline visit]
- Self-efficacy assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic. [Срок оценки: 9 months after baseline visit]
- Resilience assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic. [Срок оценки: 9 months after baseline visit]
- Impact of heritability of cardiac disease assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic. [Срок оценки: 9 months after baseline visit]
- Impact of radiation-induced heart disease (RIHD) assessed at baseline visit in the outpatient clinic. [Срок оценки: Baseline visit]
Критерии участия
Критерии включения
- Patients aged 18-70 at time of consent with a confirmed diagnosis of HCM, TAD, and/or RIHD being seen at CC Main Campus for a comprehensive clinical cardiac evaluation (i.e. physician, surgeon, nurse practitioner, geneticist, testing, imaging, etc) to define treatment plan for either diagnosis as per Cleveland Clinic provider.
- Patient or an individual in their social support network has the equipment (phone, computer, tablet) and internet connection to complete the emailed follow-up questionnaires.
Критерии исключения
- Previously had surgery or plans to have surgery (full/mini sternotomy or endovascular) in the next nine months for HCM or TAD.
- Inability or unwillingness to comply with study requirements in the opinion of the investigator.
- Inability to provide informed consent.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Cleveland Clinic — Cleveland
Идентификаторы
NCT: NCT04080492 · 19-1007