Effectiveness of Educational Interventions to Reduce Concerns About Falling, Falls and Associated Outcomes Among Older Adults: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Concern about Falling
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Printed Educational Materials
The control group will receive a lecture on general healthy aging (not related to falls) and printed fall-related educational leaflets.
干预措施: Printed Educational Materials (Behavioral)
Interactive Fall Prevention Education
Participants will receive a group-based interactive educational program on fall prevention delivered over six sessions (delivered once a week).
干预措施: Interactive Fall Prevention Education (Behavioral)
结局指标
主要结局
Concern about Falling
时间窗: Baseline, 6 weeks, 3 months, and 6 months
Concern about falling will be measured using the Falls Efficacy Scale International (FES-I). Scores range from 16 to 64, with higher scores indicating greater concern about falling
次要结局
- Proportion of participants with at least one fall(Baseline, 6 weeks, 3 months, and 6 months)
- Number of Falls(Baseline, 6 weeks, 3 months, and 6 months)
- Knowledge about fall prevention(Baseline, 6 weeks, 3 months, and 6 months)
- Fall risk awareness(Baseline, 6 weeks, 3 months, and 6 months)
- Number of near-falls(Baseline, 6 weeks, 3 months, and 6 months)
- Proportion of participants with at least one near-fall(Baseline, 6 weeks, 3 months, and 6 months)
研究者
Alessandra Lamas Granero Lucchetti
Associate Professor
Federal University of Juiz de Fora