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Набор скоро начнётся NCT07275892

Pilot Feasibility Trial of a Peer Support Program for Trauma Survivors

Без фазы С лечением Traumatic Injury Burns Amputation Mental Health Outcomes

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: Cross-continuum Peer Support Program.
Кому может быть актуально
Состояния в реестре: Traumatic Injury, Burns, Amputation, Mental Health Outcomes. 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 →

Обзор

Traumatic injuries from events like car crashes, falls, or fires are a leading cause of disability. Survivors often face not only physical challenges but also long-lasting pain, mental health challenges and difficulty returning to work and family life. Although medical care focuses on physical recovery, survivors frequently report that their emotional and social needs are overlooked and unmet. Peer support-guidance from people who have lived through similar injuries-can reduce distress and improve coping. However, no programs in Canada currently provide peer support to trauma survivors across their recovery journey, from hospital to rehabilitation to community living. The investigators worked with trauma survivors, caregivers, and healthcare providers to co-design a Peer Support Program (PSP) that offers support throughout these stages. This pilot study will test whether the program is feasible and acceptable, and explore its early impact on recovery. Results will guide a future larger trial to expand peer support in trauma care.

Вмешательства

  • Поведенческое Cross-continuum Peer Support Program
    Trained trauma-survivor peer supporters (n=4), supported by a research team member; peers complete a 5-session training covering trauma-informed communication, boundaries, crisis de-escalation, self-care, and secondary trauma. Trauma survivors will be recruited in acute care and have the option to meeting once with a trained peer supporter prior to discharge to inpatient rehabilitation. In in-patient rehab they will attend 1 hour peer support group sessions facilitated by the trained peer suppor

Первичные конечные точки

  • Feasibility of implementing the Peer Support Program [Срок оценки: From recruitment to 3 months post intervention]
Вторичные конечные точки (7)
  • Community Reintegration - Normal Living Index (RNL) Index [Срок оценки: Baseline, up to 2 weeks post intervention, and 3-months post intervention]
  • Coping Self-Efficacy (CSE) - 20-item CSE Scale [Срок оценки: Baseline, up to 2 weeks post intervention, and 3-months post intervention]
  • Health-Related Quality of Life - The Short-Form 36 (SF-36) [Срок оценки: Baseline, up to 2 weeks post intervention, and 3-months post intervention]
  • Post-Traumatic Stress Disorder (PTSD) - The PTSD Checklist-Civilian Version (PCL-C) [Срок оценки: Baseline, up to 2 weeks post intervention, and 3-months post intervention]
  • Post-Traumatic Growth - The Post-Traumatic Growth Inventory (PTGI) [Срок оценки: Baseline, up to 2 weeks post intervention, and 3-months post intervention]
  • Social Support - The Medical Outcomes Study Social Support Survey (MOS-SS) [Срок оценки: Baseline, up to 2 weeks post intervention, and 3-months post intervention]
  • Loneliness and Social Isolation -The UCLA 3-Item Loneliness Scale [Срок оценки: Baseline, up to 2 weeks post intervention, and 3-months post intervention]

Критерии участия

Критерии включения

  • adult patients (18 years+) who have experienced an unintentional traumatic injury resulting in hospitalization at Sunnybrook and who will be discharged to inpatient rehabilitation at St. John's Rehab after acute care.
  • must be able to communicate in English

Критерии исключения

  • patients who experienced: a) an intentional self-harm injury (because self-harm suggests a history of mental health issues prior to the trauma requiring specific psychiatric supports)
  • patients who experienced: an injury caused by an intimate partner (because these injuries are typically underpinned by chronic exposure to domestic violence which requires interventions that promote patient safety and interrupt the pattern of violence)
  • patients who experienced: a violently-acquired injury (as this patient population already receives specific clinical and social support through Sunnybrook's BReAking the Cycle of Violence with Empathy (BRAVE) program).
  • patients with substantial cognitive impairment and a history of substance misuse if their HCPs indicate that either condition will impede the their ability to provide informed consent and/or participate safely in the trial

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Канада · 2 центра
  • St. John's Rehab at Sunnybrook — Toronto
  • Sunnybrook Health Sciences Centre — Toronto

Публикации

  • Dennis CL. Peer support within a health care context: a concept analysis. Int J Nurs Stud. 2003 Mar;40(3):321-32. doi: 10.1016/s0020-7489(02)00092-5. PMID 12605954
  • Braun V, Clarke V. Reflecting on reflexive thematic analysis. Qualitative research in sport, exercise and health. 2019;11(4):589-597
  • Braun V, Clarke V. One size fits all? What counts as quality practice in (reflexive) thematic analysis? Qualitative research in psychology. 2021;18(3):328-352
  • Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006/01/01 2006;3(2):77-101. doi:10.1191/1478088706qp063oa
  • Hitzig SL, Gotlib Conn L, Guilcher SJT, Cimino SR, Robinson LR. Understanding the role of the physiatrist and how to improve the continuum of care for trauma patients: a qualitative study. Disabil Rehabil. 2021 Oct;43(20):2846-2853. doi: 10.1080/09638288.2020.1719215. Epub 2020 Feb 4. PMID 32017865
  • Wasilewski MB, Stinson JN, Webster F, Cameron JI. Using Twitter to recruit participants for health research: An example from a caregiving study. Health Informatics J. 2019 Dec;25(4):1485-1497. doi: 10.1177/1460458218775158. Epub 2018 May 30. PMID 29843545
  • Thorogood N, Green J. Qualitative Methods for Health Research. SAGE Publications Ltd.; 2009
  • Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664. PMID 34812790

Идентификаторы

NCT: NCT07275892 · 6905

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗