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Набор скоро начнётся NCT07515053

Educational Interventions to Reduce Concerns About Falling, Falls and Associated Outcomes Among Older Adults

Без фазы С лечением Concerns About Falling Falls Fall Prevention

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: Interactive Fall Prevention Education, Printed Educational Materials.
Кому может быть актуально
Состояния в реестре: Concerns About Falling, Falls, Fall Prevention. 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
Бразилия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effectiveness of Educational Interventions to Reduce Concerns About Falling, Falls and Associated Outcomes Among Older Adults: a Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if an active educational intervention (using interactive and active methods of teaching) works better than the traditional lecture teaching to reduce concerns of falling, falls and other health problems among older adults. The main questions it aims to answer are: Does having more dynamic interactive educational interventions can performed better than using just traditional lectures? Are these interventions able to reduce concerns of falling, fears and other outcomes among older adults? Participants will: Receive one of the interventions (active/interactive or traditional lecture) Answer self-report questionnaires related to concerns of falls and falls Perform some fall-related tests Be followed for 3 and 6 months

Подробное описание

Previous studies and meta-analyses have shown that educational strategies for fall prevention are still underexplored and have produced inconsistent results, possibly due to the limited use of appropriate educational methods and approaches that effectively change older adults' perceptions and behaviors related to falls.

This study aims to investigate the effects of a six-week educational intervention using active learning methodologies on concern about falling in community-dwelling older adults compared to a control group. Our secondary objectives are to evaluate whether the educational intervention reduces fall events and near-fall events and improves knowledge and awareness related to fall prevention in older adults.

This is a randomized, parallel-group trial in which participants will be allocated to either an interactive educational intervention group (active methods of teaching) or a control group receiving the same educational content through printed materials and a lecture on general healthy aging.

Follow-up assessments will be conducted immediately after the intervention period (6 weeks), and at 3 months and 6 months after the intervention. Falls and near-falls will be monitored throughout the follow-up period using follow-up contacts.

Вмешательства

  • Поведенческое Interactive Fall Prevention Education
    Arm/Group Experimental: Interactive Fall Prevention Education Arm Description: The intervention will be carried out in groups of 12 to 17 participants. There will be six educational sessions (delivered once a week) focusing on the following fall prevention topics: (1) impact of falls and aging-related changes; (2) identification of fall risk and protective factors; (3) home safety and environmental modifications; (4) fall prevention strategies; (5) concern about falling and what to do after a fa
  • Поведенческое Printed Educational Materials
    The control group will receive a lecture on general healthy aging (not related to falls) and printed educational leaflets covering the same six fall prevention topics addressed in the interactive educational intervention, including fall risk factors, home safety, prevention strategies, and what to do after a fall. The educational content will be delivered only through printed materials and not through interactive sessions.

Первичные конечные точки

  • Concern about Falling [Срок оценки: Baseline, 6 weeks, 3 months, and 6 months]
Вторичные конечные точки (6)
  • Proportion of participants with at least one fall [Срок оценки: Baseline, 6 weeks, 3 months, and 6 months]
  • Number of Falls [Срок оценки: Baseline, 6 weeks, 3 months, and 6 months]
  • Knowledge about fall prevention [Срок оценки: Baseline, 6 weeks, 3 months, and 6 months]
  • Fall risk awareness [Срок оценки: Baseline, 6 weeks, 3 months, and 6 months]
  • Number of near-falls [Срок оценки: Baseline, 6 weeks, 3 months, and 6 months]
  • Proportion of participants with at least one near-fall [Срок оценки: Baseline, 6 weeks, 3 months, and 6 months]

Критерии участия

Критерии включения

  • Participants with 60 years old or older
  • At least one fall in the previous 12 months.
  • A minimum score for the Mini-Mental State Examination (MMSE) according to educational level: Illiterate: 13, 1 to 7 years of schooling: 18, More than 7 years of schooling: 26

Критерии исключения

  • MMSE score below the minimum cutoff for educational level.
  • Current participation in regular physical therapy treatment.
  • Presence of severe neurological, motor, and/or visual impairments that may interfere with participation in the study.
  • Refusal or inability to provide informed consent

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
Простое слепое
Основная цель
Профилактика

Центры проведения

Бразилия · 1 центр
  • School of Medicine, Federal University of Juiz de Fora — Juiz de Fora

Идентификаторы

NCT: NCT07515053 · UFJF-EDU-FALLS-26

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗