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Идёт набор NCT07610161

Patient Experience of Older Adults Living Alone With Injuries

Без фазы С лечением Geriatrics Trauma Injury Living Alone

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: Geriatric Trauma Care Program.
Кому может быть актуально
Состояния в реестре: Geriatrics, Trauma Injury, Living Alone. Базовые параметры: 65 лет — 74 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
Тайвань
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

Patient Experience of Older Adults Living Alone With Injuries and Long-Term Effects of Geriatric Trauma Care Program for Living Alone Older Adults With Injuries

Обзор

This study aims to explore the patient experiences of living alone older adults with injuries, and to examine the effects of a "Geriatric Trauma Care Program" in older adults with limb injuries who live alone. A three-year design will be used to reach the purposes of this study. The first stage of this study will use descriptive phenomenology to get patient experiences of living alone older adults with injuries. In the second stage of this study, a two-arm experimental design will be used.

Подробное описание

Aim: This study aims to explore patient experience of living alone older adults with injuries, and to examine effects of a "Geriatric Trauma Care Program (GTCP)" in older adults with limb injuries who live alone.

Design: A two-stage design will be used to reach the purposes of this study. The first stage of this study will use descriptive phenomenology to get patient experiences of living alone older adults with injuries. In the second stage, a two-arm experimental design will be used to intervene the "GTCP" and evaluate its outcomes.

Methods: In the first stage, the study settings will be surgical outpatient departments at a university hospital. Purposive sampling will be used to select old adult patients with injury and living alone. Semi-structured and audio-taped interviews will be used as data collection method. About 15 to 20 participants are planned to be interviewed. Colaizzi's (1978) methods will be applied to data analysis. The findings will be used to modify the intervention for the second stage in this study.

In the second stage, a two-arm experimental design will be used. The participants will be older adults with limb injuries. The experiment group will receive the "GTCP" and routine care, and the control group will receive routine care only. The GTCP includes a two-session intervention named "Digital geriatric trauma care" and "Multiple training modalities". The two sessions will use an "age-friendly e-Book" and a "personalized-oriented App" as assistant materials. A three-time point data collection will be used including at hospital discharge, 1 month and 3 months after hospital discharges. The pre -and post- intervention measures will be five structured scales including pain, functional disability, geriatric depression, loneliness, and quality of life. The 2nd stage expects to collect 45 participants in each group. The experimental effects will be examined by the generalized estimating equations (GEEs) model.

Вмешательства

  • Другое Geriatric Trauma Care Program
    The intervention program named GTCP includes two sessions with two digital materials named "Digital geriatric trauma care" (DGTC) and "Multiple training modalities" (MTM). The DGTC has been establishing as an Age-friendly e-Book. It has six units. The MTM has three units including "handwritten wisdom quotes", "6-minute meditation", "inspirational words".

Первичные конечные точки

  • The Numeric Pain Rating Scale (NPRS) [Срок оценки: at 1 day before hospital discharge]
  • The Barthel's Index (BI) [Срок оценки: at 1 day before hospital discharge]
  • The Geriatric Depression Scale Short Form (GDS-SF) [Срок оценки: at 1 day before hospital discharge]
  • The Elderly Loneliness Scale (ELS) [Срок оценки: at 1 day before hospital discharge]
  • Taiwanese version of the EuroQol-5D (EQ-5D) [Срок оценки: at 1 day before hospital discharge]
  • The Numeric Pain Rating Scale (NPRS) [Срок оценки: at 1 months after hospital discharge]
  • The Barthel's Index (BI) [Срок оценки: at 1 months after hospital discharge]
  • The Geriatric Depression Scale Short Form (GDS-SF) [Срок оценки: at 1 months after hospital discharge]
  • The Elderly Loneliness Scale (ELS) [Срок оценки: at 1 months after hospital discharge]
  • Taiwanese version of the EuroQol-5D (EQ-5D) [Срок оценки: at 1 months after hospital discharge]

Критерии участия

Критерии включения

  • willing to join this study for 12 weeks
  • limb injuries,
  • living alone without any family,
  • 65 to 74 years old,
  • independent before an injury,
  • have a smart phone
  • be able to communicate in Mandarin

Критерии исключения

  • with an ISS greater than 16 (severe injuries)
  • severe cognitive impairment
  • severe illness such as organ system insufficiency
  • diagnosed with depression

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Тайвань · 2 центра
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
  • Kaohsiung Medical University — Kaohsiung City

Идентификаторы

NCT: NCT07610161 · KMUHIRB-F(I)-20230043

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗