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Идёт набор NCT07512505

Remote Vital Sign Monitoring in Palliative Care Patients Using a Wearable ECG Monitor

Наблюдательное Cancer Malignancies Multiple Terminal Care Hospice

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Cancer, Malignancies Multiple, Terminal Care, Hospice. 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
Ирландия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Remote Vital Sign Monitoring in Palliative Care - VITAL-PC

Обзор

The goal of this study is the assess the use of remote monitoring of vital signs using commercially available medical devices in patients with advanced cancer admitted to a hospice inpatient unit for end-of-life care. The objectives of the study are: 1. could remote monitoring of vital signs improve patient care through the earlier identification of infections and other (potentially reversible) problems; 2. could remote monitoring of vital signs improve the accuracy of our estimates about how long a person has to live; and c) determine the relationship between complaints of pain / other symptoms and vital signs.

Подробное описание

This study will take place in the palliative care unit at Our Lady's Hospice \& Care Services and will consist of applying a small, flexible, patch-like device to the participant's chest with an adhesive patch.

If the participant is happy to take part in the study, they will be visited by a member of the research team. This meeting provides the opportunity to discuss the study, answer any questions and complete a consent form.

The researcher will also collect some information about the participant's condition, and medication from their medical notes and drug chart. The participant will need to wear the device for the duration of their time in the hospice. The research team will remotely check that the device is working properly, and will change the device when the battery needs re-charging (every 14 days). The research team will review the participant after 24 hr (to ensure no problems), and then a couple of times a week during the study. The nursing team will check that the patch is sticking properly every day.

The medical / nursing team will not have access to the information from the device, and so will not make any clinical decisions on the basis of this information.

The device will continue to be worn until the patient dies, the patient withdraws, the patient is discharged, or the patient improves (and is no longer receiving end-of-life care). At the end of the participant's stay on the hospice the device will be removed and cleaned / sterilized according to the manufacturer's instructions (the adhesive patches that secure the device to the chest wall are disposable / not reusable).

The study will recruit 120 patients - this number is pragmatic, and based upon annual admission data for OLH\&CS (and the likelihood of end-of-life patients to engage in research).

Currently, the plan is to use descriptive statistics, and standard statistical methods to analyse the study data. However, we are engaging with colleagues at UCD about using machine learning to undertake further analyses. A formal statistical analysis plan will be developed prior to the primary analysis.

Первичные конечные точки

  • Mean, standard deviation, median, and range of heart rate variability (HRV) at predefined time intervals prior to death [Срок оценки: From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death]
Вторичные конечные точки (5)
  • Mean, standard deviation, median, and range of heart rate at predefined time intervals prior to death [Срок оценки: From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death]
  • Mean, standard deviation, median, and range of respiratory rate at predefined time intervals prior to death [Срок оценки: From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death]
  • Mean, standard deviation, median, and range of skin temperature at predefined time intervals prior to death [Срок оценки: From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death]
  • Number of participants with clinical events (e.g. increased PRN medication use) [Срок оценки: From device initiation until death (up to 14 days)]
  • Number of participants with clinical events (e.g. infection) [Срок оценки: From device initiation until death (up to 14 days)]

Критерии участия

Критерии включения

  • Age ≥ 18 years old
  • Primary diagnosis of malignant disease
  • Admitted for end-of-life care (or focus of care changed to end-of-life care)
  • Estimated prognosis < 14 days

Критерии исключения

  • Primary diagnosis of non-malignant disease
  • Inability to provide informed consent
  • Contraindications to use of biosensor adhesive patch (e.g. chest wall skin problem, allergy to adhesive)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Ирландия · 1 центр
  • Our Lady's Hospice and Care Services — Dublin

Публикации

  • Power J, Gouldthorpe C, Davies A. Vital Signs in Palliative Care: A Scoping Review. Cancers (Basel). 2023 Sep 20;15(18):4641. doi: 10.3390/cancers15184641. PMID 37760611
  • Seymour JE. Revisiting medicalisation and 'natural' death. Soc Sci Med. 1999 Sep;49(5):691-704. doi: 10.1016/s0277-9536(99)00170-7. PMID 10452423
  • Ellershaw J, Wilkinson S. Care of the dying. a pathway to excellence. Oxford University Press: Oxford, UK; 2003.
  • Veerbeek L, van Zuylen L, Swart SJ, van der Maas PJ, van der Heide A. The last 3 days of life in three different care settings in The Netherlands. Support Care Cancer. 2007 Oct;15(10):1117-23. doi: 10.1007/s00520-006-0211-x. Epub 2007 Mar 15. PMID 17357794
  • Olsson T, Terent A, Lind L. Rapid Emergency Medicine score: a new prognostic tool for in-hospital mortality in nonsurgical emergency department patients. J Intern Med. 2004 May;255(5):579-87. doi: 10.1111/j.1365-2796.2004.01321.x. PMID 15078500

Идентификаторы

NCT: NCT07512505 · RS25-044

Первоисточники (государственные реестры)

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