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Идёт набор NCT06569901

Strengthening Hope After ICU Discharge

Без фазы С лечением Critical Care

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: Hope Intervention.
Кому может быть актуально
Состояния в реестре: Critical Care. Базовые параметры: 18 лет — 85 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

To Strengthen the Patients Hope After Discharge From the Intensive Care Unit - a Stepped Wedge Cluster Randomized Trial

Обзор

The goal of this clinical trial is to evaluate an interventional program that aims to strengthen hope in intensive care unit (ICU) patients in the rehabilitation phase. The main questions it aims to answer are: To develop and implement a follow-up service to strengthen hope in ICU patients, and to evaluate the effect on hope in a stepped wedge randomized trial. To identify possible predictive factors (facilitators and barriers) associated with hope. Participants will be asked to take part in an ICU follow-up service, a "Hope Intervention" consisting of digital individual- and group conversations. The program will address topics that are important for hope, such as active involvement, social relationships, believes and thoughts of the future. We will compare the level of hope between participants who have completed the "Hope Intervention" to those that have not yet completed the program.

Подробное описание

The ICU patient's situation is challenging as they are acutely ill over a prolonged period of time and receive life sustaining treatment in the ICU.

Having hope and belief in a positive future, even when the prospects of such future are uncertain, may give strength and motivation and possibly improve the outcome in the rehabilitation phase. Hope is scarcely described in ICU patients.

Health care professionals need to learn how to best support ICU patients and promote hope during the rehabilitation period. Therefore, the main aim of the present study is to develop, implement and evaluate a follow up service to former ICU patients to strengthen their hope using a stepped wedge cluster randomized control intervention trial (SW-CRT). The secondary aim is to identify possible predictive factors associated with hope.

The intervention will start after hospital discharge and will be carried out in group sessions.

Вмешательства

  • Поведенческое Hope Intervention
    Group meetings after hospital discharge reflecting on themes that may have an impact on hope. The Hope Intervention consists of four group meetings and two individual conversations during a four week period.

Первичные конечные точки

  • Hope [Срок оценки: Baseline and 1,2,3,4 and 5 months after baseline]
Вторичные конечные точки (5)
  • Social Provsion Scale [Срок оценки: Baseline and 1,2,3,4 and 5 months after baseline]
  • Charlson comorbidity Index [Срок оценки: Within 2 months after inclucion]
  • Memorial Symptom Assessment Scale [Срок оценки: Baseline and 1,2,3,4 and 5 months after baseline]
  • General Perceived Self-Efficacy Scale [Срок оценки: Baseline and 1,2,3,4 and 5 months after baseline]
  • Cognitive Failure Questionnaire [Срок оценки: Baseline and 1,2,3,4 and 5 months after baseline]

Критерии участия

Критерии включения

  • Patients ≥18 years
  • ICU patient for > 48 hours
  • must be able to communicate verbally just after their ICU stay and be able to handle digital meetings

Критерии исключения

  • Patients with severe cognitive impairment
  • Do not understand and speak Norwegian
  • Patients with major psychiatric challenges, suicidal attempts as a reason for ICU stay
  • Age over 85 years.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Норвегия · 3 центра
  • Vestre Viken HF, Bærum Hospital — Drammen
  • Diakonhjemmet Hospital — Oslo
  • Oslo University Hospital — Oslo

Публикации

  • Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. doi: 10.1111/j.1365-2648.1992.tb01843.x. PMID 1430629
  • Schneeweiss S, Wang PS, Avorn J, Glynn RJ. Improved comorbidity adjustment for predicting mortality in Medicare populations. Health Serv Res. 2003 Aug;38(4):1103-20. doi: 10.1111/1475-6773.00165. PMID 12968819
  • Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x. PMID 7126941
  • Russell D, Cutrona CE, Rose J, Yurko K. Social and emotional loneliness: an examination of Weiss's typology of loneliness. J Pers Soc Psychol. 1984 Jun;46(6):1313-21. doi: 10.1037//0022-3514.46.6.1313. PMID 6737214
  • Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326-36. doi: 10.1016/0959-8049(94)90182-1. PMID 7999421
  • Dufault K, Martocchio BC. Symposium on compassionate care and the dying experience. Hope: its spheres and dimensions. Nurs Clin North Am. 1985 Jun;20(2):379-91. PMID 3846980

Идентификаторы

NCT: NCT06569901 · 542348

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗