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Идёт набор NCT07396532

Audio-Recorded Messages Delivered Via iPad to Prevent Delirium in Hip Fracture Patients

Без фазы С лечением Delirium - Postoperative Delirium and Post-operative Cognitive Dysfunction (POCD) Delirium, Postoperative

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: Audio-Recorded Reorientation Intervention.
Кому может быть актуально
Состояния в реестре: Delirium - Postoperative, Delirium and Post-operative Cognitive Dysfunction (POCD), Delirium, Postoperative. Базовые параметры: от 60 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
Сингапур
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Nurse-Led Audio-Recorded Reorientation to Reduce Delirium in Elderly Hip Fractures: A Pilot Randomized Control Trial

Обзор

The goal of this pilot clinical trial is to learn if personalized audio-recorded reorientation messages can be successfully implemented in general hospital wards for elderly patients after hip fracture surgery. It will also explore whether this intervention might help prevent confusion (delirium) after surgery. The main questions it aims to answer are: * Can the intervention be successfully delivered by nursing staff in a busy orthopedic ward? * How many eligible patients can be recruited and retained in the study? * Do patients tolerate listening to the personalized audio messages without problems? * Does listening to personalized audio messages show any early signs of reducing confusion after surgery? Researchers will compare patients who receive personalized audio messages to those who receive usual care to see if the intervention is feasible to implement and whether it shows promise for preventing delirium. Participants will: * Listen to 2-minute personalized audio-recorded reorientation messages played through an iPad and headphones three times daily for the first 3 days after surgery * Have their orientation and mental status checked daily for three times by nursing staff * Continue with all their regular medical care and treatments * Be monitored until discharge from the study wards.

Подробное описание

Background and Rationale:

Hip fracture surgery is common among elderly patients, but recovery can be complicated by post-operative delirium (confusion), which affects up to 50% of patients and can lead to longer hospital stays, increased complications, and delayed rehabilitation. Non-pharmacological interventions, particularly reorientation strategies, have shown promise in preventing delirium, but implementation in busy hospital wards remains challenging.

Study Design and Innovation:

This pilot randomized controlled trial tests an innovative approach using personalized audio-recorded reorientation messages delivered via 'Shortcut' Application on the iPad technology. The messages are available in multiple languages (English, Mandarin, Malay, Tamil) to accommodate the diverse patient population, but the content is standardized across all participants. This technology-supported approach enables nurses to provide systematic reorientation interventions as part of their routine care.

Intervention Details:

The audio messages are approximately 2 minutes long and include: reorientation information (patient's location, real-time update of date and time, reason for admission), explanation of their recovery process, encouragement for therapy participation, pain management guidance, and reassuring messages on who are taking care of them in the hospital. Messages are played through noise-canceling headphones to ensure clarity and minimize ward noise interference.

Implementation Approach:

Nursing staff receive brief training on the iPad system and the workflow process. The intervention is designed to be sustainable within existing workflow patterns without adding significant burden to clinical staff. Visual reminders of workflow process were also readily available in nursing stations to remind the nurses. Study team also do their rounds to ensure availability of equipment and to clarify doubts from nursing staff.

Target Population:

Elderly patients (≥60 years) admitted to orthopedic wards following hip fracture surgery who are at risk for developing post-operative delirium based on established risk factors.

Feasibility Focus:

As a pilot study, this research prioritizes understanding implementation challenges, staff acceptance, patient tolerance, and recruitment feasibility to inform the design of a future definitive trial examining delirium prevention effectiveness.

Вмешательства

  • Поведенческое Audio-Recorded Reorientation Intervention
    Participants in this arm receive personalized audio-recorded reorientation messages delivered three times daily during the first three post-operative days. Each message lasts approximately 2 minutes and contains personalized information including the current location, date and time, and encouraging messages. Messages are delivered via iPad and headphones by nursing staff during routine care. Audio messages are available in English, Mandarin, Malay, and Tamil to accommodate patient language prefe

Первичные конечные точки

  • Protocol Adherence Rate [Срок оценки: Postoperative day 1 to postoperative day 3]
  • Recruitment Feasibility [Срок оценки: From enrollment to end of study participation (up to 2 weeks)]
  • Study Retention Rate [Срок оценки: From enrollment to end of study participation (up to 2 weeks)]
  • Intervention Tolerance Rate [Срок оценки: Postoperative Day 1 to Postoperative Day 3]
Вторичные конечные точки (4)
  • Number of participants with delirium as assessed by 4AT (4 'A's Test) screening tool [Срок оценки: From postoperative day 1 to end of study participation (up to 2 weeks)]
  • Length of stay in study ward measured in days [Срок оценки: From admission to pilot ward until discharge/transfer from pilot ward (up to 2 weeks)]
  • Number of participants actively participating in prescribed physiotherapy and occupational therapy sessions [Срок оценки: From postoperative day 1 to postoperative day 3]
  • Cumulative analgesic consumption [Срок оценки: From postoperative day 1 to postoperative day 3]

Критерии участия

Критерии включения

  • Older adults aged 60 years and above
  • Undergoing hip fracture repair surgery
  • No history of cognitive impairment as assessed by Abbreviated Mental Test (AMT)
  • Able to understand to any of the basic languages of Singapore (English, Malay, Mandarin, Tamil)

Критерии исключения

  • Patients not admitted directly to orthopaedic (study) wards post-operation (such as those requiring post-operative high-dependency unit care)
  • Patients managed conservatively without surgical intervention.
  • Patients admitted for periprosthetic hip fracture repairs
  • Patients who are deaf and mute

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Сингапур · 1 центр
  • Sengkang General Hospital — Singapore

Публикации

  • Munro CL, Cairns P, Ji M, Calero K, Anderson WM, Liang Z. Delirium prevention in critically ill adults through an automated reorientation intervention - A pilot randomized controlled trial. Heart Lung. 2017 Jul-Aug;46(4):234-238. doi: 10.1016/j.hrtlng.2017.05.002. Epub 2017 Jun 9. PMID 28606450
  • Kasapoglu ES, Enc N. Role of multicomponent non-pharmacological nursing interventions on delirium prevention: A randomized controlled study. Geriatr Nurs. 2022 Mar-Apr;44:207-214. doi: 10.1016/j.gerinurse.2022.02.015. Epub 2022 Feb 26. PMID 35227973

Идентификаторы

NCT: NCT07396532 · 2025-0733 · CIRB-2025-0733

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗