Neuroscience Research Australia, Randwick, New South Wales, Australia
School of Population Health, University of New South Wales, Sydney, New South Wales, Australia.
BMJ Open. 2024 Feb 2;14(2):e078486. doi: 10.1136/bmjopen-2023-078486.
Concerns about falling (CaF) are common in older people and have been associated with avoidance of activities of daily life. Exercise designed to prevent falls can reduce CaF, but the effects are usually short-lived. Cognitive behavioural therapy (CBT) can reduce CaF for longer but is not readily available in the community and unlikely to prevent falls. A multidomain intervention that combines CBT, motivational interviewing and exercise could be the long-term solution to treat CaF and reduce falls in older people with CaF. This paper describes the design of a randomised controlled trial to test the effectiveness of two different 12 week self-managed eHealth programmes to reduce CaF compared with an active control.
A total of 246 participants (82 per group) aged 65 and over, with substantial concerns about falls or balance will be recruited from the community. They will be randomised into: (1) myCompass-Own Your Balance (OYB) (online CBT programme) intervention or (2) myCompass-OYB plus StandingTall intervention (an eHealth balance exercise programme), both including motivational interviewing and online health education or (3) an active control group (online health education alone). The primary outcome is change in CaF over 12 months from baseline of both intervention groups compared with control. The secondary outcomes at 2, 6 and 12 months include balance confidence, physical activity, habitual daily activity, enjoyment of physical activity, social activity, exercise self-efficacy, rate of falls, falls health literacy, mood, psychological well-being, quality of life, exercise self-efficacy, programme adherence, healthcare use, user experience and attitudes towards the programme. An intention-to-treat analysis will be applied. The healthcare funder's perspective will be adopted for the economic evaluation if appropriate.
Ethical approval was obtained from the South Eastern Sydney Local Health District Human Research Ethics Committee (2019/ETH12840). Results will be disseminated via peer-reviewed journals, local and international conferences, community events and media releases.
ACTRN12621000440820.
老年人普遍存在对跌倒的担忧，并已与日常生活活动的回避有关。旨在预防跌倒的运动可以减少跌倒恐惧，但效果通常是短暂的。认知行为疗法（CBT）可以更长期地减少跌倒恐惧，但在社区中不易获得，也不太可能预防跌倒。一种将 CBT、动机访谈和运动相结合的多领域干预措施可能是治疗老年人跌倒恐惧和减少跌倒的长期解决方案。本文介绍了一项随机对照试验的设计，以测试两种不同的 12 周自我管理电子健康计划与积极对照组相比，减少跌倒恐惧的有效性。
总共将招募 246 名年龄在 65 岁及以上、对跌倒或平衡有较大担忧的社区参与者（每组 82 名）。他们将被随机分为：（1）myCompass-Own Your Balance（OYB）（在线 CBT 计划）干预组或（2）myCompass-OYB 加 StandingTall 干预组（在线平衡运动计划），均包括动机访谈和在线健康教育，或（3）积极对照组（仅在线健康教育）。主要结局是从基线开始，12 个月内两组干预组跌倒恐惧的变化与对照组相比。次要结局在 2、6 和 12 个月包括平衡信心、身体活动、日常习惯性活动、身体活动的享受、社交活动、运动自我效能、跌倒率、跌倒健康素养、情绪、心理健康、生活质量、运动自我效能、计划依从性、医疗保健使用、用户体验和对计划的态度。如果适用，将采用意向治疗分析。如果合适，将从医疗保健资助者的角度进行经济评估。
该研究已获得南悉尼东南地方卫生区人体研究伦理委员会的伦理批准（2019/ETH12840）。结果将通过同行评议的期刊、地方和国际会议、社区活动和媒体发布进行传播。
ACTRN12621000440820。
