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Идёт набор NCT06444321

INTEgRated Health CARE for Patients With Frailty and Heart Failure

Без фазы С лечением Heart Failure Frailty Frail Elderly Syndrome Symptom, Behavioral

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: INTERCARE-HF.
Кому может быть актуально
Состояния в реестре: Heart Failure, Frailty, Frail Elderly Syndrome, Symptom, Behavioral. 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
Норвегия
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

INTEgRated Health CARE for Patients With Frailty and Heart Failure (INTERCARE-HF): Evaluation of an Innovation Project

Обзор

Frailty, an aging-related syndrome of physiological decline characterized by marked vulnerability to adverse health outcomes, has attracted increasing attention in cardiology due to the growing elderly population with heart failure. Frail patients are mainly excluded from large cardiovascular intervention studies, and clinical trials addressing frailty and showing an impact on treatment on symptom burden, quality of life and /or outcome has been requested in recent guidelines and consensus documents. The INTEgrRated health CARE for patients with severe frailty and Heart Failure (INTERCARE-HF) is a proof-of-concept study that aims to evaluate the effect of integrated healthcare services for heart failure patients with a severe level of frailty by establishing interdisciplinary and coordinated follow-up teams across the healthcare boundaries. These teams will assess the patient's needs, goals, and risk areas, conduct advance care planning, and develop individualized treatment and follow-up plans. An open-label, non-randomized intervention study aims to recruit 20 patients and heart failure and a clinical Frailty Score (CSF) \>=5. A control-group (N=40) matched on age an clinical frailty scale score will be included. The overall hypothesis is that the intervention is feasible in routine clinical practice with favorable effects on quality of life, symptoms, caregiver distress, and healthcare service utilization.

Вмешательства

  • Поведенческое INTERCARE-HF
    Develpent of an individualized treatment and follow-up plan tailored to co-morbidities, risk areas, cognitive function and functional level as well as the patients' symptoms and needs.

Первичные конечные точки

  • Changes in symptom control and patient satisfaction [Срок оценки: From baseline to weeks 6, 12, and 52]
  • Changes in health-related quality of life [Срок оценки: From baseline to weeks 6, 12, and 52]
Вторичные конечные точки (4)
  • Changes in caregiver distress [Срок оценки: From baseline to weeks 6, 12, and 52]
  • Total number of days lost due to unplanned hospital re-admissions during the follow-up [Срок оценки: From baseline to weeks 6, 12, and 52]
  • The number of days lost due to unplanned hospital re-admissions for specific diagnosis during the follow-up [Срок оценки: From baseline to weeks 6, 12, and 52]
  • Total number of hospitalizations [Срок оценки: From baseline to weeks 6, 12, and 52]

Критерии участия

Критерии включения

  • Age >18 years old
  • Admitted to hospital with heart failure with symptoms of decompensation including dyspnoea in NYHA class ≥ II, pulmonary congestion on chest x-ray and/or other signs like oedema or positive rales on auscultation and elevated NT-proBNP concentrations at screening
  • Clinical Frailty Score ≥5
  • Signed informed consent by patient and closest relatives\* and expected cooperation according to the protocol, ICH/GCP and national/local regulations
  • Although we preferably will recruit both patients and their relatives, participation from the next-of-kin will not be an exclusion criterium.

Критерии исключения

  • Inability to comply with all study requirements, due to major co-morbidities or psychosocial issues, or a history of noncompliance, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures.
  • Not being able to understand Norwegian.
  • Permanent nursing home and estimated to stay alive for less than 6 months

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Норвегия · 1 центр
  • Drammen Hospital — Drammen

Идентификаторы

NCT: NCT06444321 · 678261

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗