Набор скоро начнётся NCT06984770

The Family Cares Trial

Без фазы С лечением Family Engagement Critical Care, Intensive Care Patient and Family Engagement Health Care Delivery

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: Virtual peer support group intervention, Caregiver Support intervention, Resources.
Кому может быть актуально: Состояния в реестре: Family Engagement, Critical Care, Intensive Care, Patient and Family Engagement, Health Care Delivery. 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: Канада
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

Caring for the Caregiver: A Pilot Randomized Controlled Trial (The Family Cares Trial)

Обзор

The goal of this pilot study is to learn if virtual peer support groups and strengths-based skills training can help family caregivers of ICU survivors providing ongoing support to ICU survivors after hospital discharge. The main question it aims to answer is: \- Are virtual peer support groups and/or strengths-based skills support feasible and acceptable for family caregivers of ICU survivors? Researchers will compare the intervention group (virtual peer support groups or strengths-based skills training) to the control group (no intervention) to see if the interventions improve caregiver outcomes and assess feasibility and acceptability. Participants will: * Participate in either virtual peer support groups or strengths-based skills training sessions (if assigned to the intervention arm). * Provide feedback on the feasibility and acceptability of the interventions (if assigned to the intervention arm). * Complete surveys and follow-up questionnaires (either online or by phone) to measure outcomes.

Вмешательства

Поведенческое Virtual peer support group intervention
The virtual peer support group aims to improve emotional well-being, reduce isolation, and help caregivers cope by offering a safe space to share experiences and receive support from others facing similar caregiving demands.
Поведенческое Caregiver Support intervention
The caregiver support intervention is a personalized program designed to improve quality of life, reduce fatigue and caregiver burden, and build resilience.
Другое Resources
Participants will be given a list of resources to contact in case of emotional or psychological distress.

Первичные конечные точки

Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 3 months [Срок оценки: 3 months post-enrollment or post intervention initiation]

Вторичные конечные точки (12)

Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 6 months [Срок оценки: 6 months post-enrollment or post intervention initiation]
Multidimensional Scale of Perceived Social Support (MSPSS) - 3 months [Срок оценки: 3 months post-enrollment or post intervention initiation]
Multidimensional Scale of Perceived Social Support (MSPSS) - 6 months [Срок оценки: 6 months post-enrollment or post intervention initiation]
Patient Health Questionnaire-9 (PHQ-9) - 3 months [Срок оценки: 3 months post-enrollment or post intervention initiation]
Patient Health Questionnaire-9 (PHQ-9) - 6 months [Срок оценки: 6 months post-enrollment or post intervention initiation]
Post-traumatic stress (IES-Revised) - 3 months [Срок оценки: 3 months post-enrollment or post intervention initiation]
Post-traumatic stress (IES-Revised) - 6 months [Срок оценки: 6 months post-enrollment or post intervention initiation]
Insomnia Severity Index (ISI) - 3 months [Срок оценки: 3 months post-enrollment or post intervention initiation]
Insomnia Severity Index (ISI) - 6 months [Срок оценки: 6 months post-enrollment or post intervention initiation]
Quality of life (EuroQOL-5D-5L score) - 3 months [Срок оценки: 3 months post-enrollment or post intervention initiation]
Quality of life (EuroQOL-5D-5L score) - 6 months [Срок оценки: 6 months post-enrollment or post intervention initiation]
Connor-Davidson Resilience Scale-10 (CD-RISC 10) - 3 months [Срок оценки: 3 months post-enrollment or post intervention initiation]

Критерии участия

Критерии включения

(1) Family member of a person admitted to an ICU for >48 hours and survived to hospital discharge. "Family" is anyone with a biological, legal, or emotional relationship with the patient and whom the patient wants involved in their care
(2) Planned or current part or full-time caregiver of the ICU survivor
(3) Age ≥ 18 years
(4) Within 6 months of ICU survivor's hospital discharge.