Supplementary Material for: Using smartphone TechnolOGy to support an EffecTive Home ExeRcise intervention to prevent falls amongst community dwelling older adults The TOGETHER feasibility RCT.

Introduction Falls have major implications for quality-of-life, independence and cost to health services. Strength and balance training has been found to be effective in reducing the rate/risk of falls, as long as there is adequate fidelity to the evidence-based programme. The aims of this study were to: (1) assess the feasibility of using the ‘Motivate Me’ and ‘My Activity Programme’ intervention to support falls rehabilitation when delivered in practice (2) assess study design and trial procedures for the evaluation of the intervention. Methods A two-arm, pragmatic feasibility randomised controlled trial was conducted with five health service providers in the UK. Patients aged 50+ years eligible for a falls rehabilitation exercise programme from community services were recruited and received either: (1) standard service with a smartphone for outcome measurement only or (2) standard service plus the ‘Motivate Me’ and ‘My Activity Programme’ apps. The primary outcome was feasibility of the intervention, study design and procedures (including recruitment rate, adherence and drop-out). Outcome measures include balance, function, falls, strength, fear of falling, health related quality of life, resource use and adherence, measured at baseline, three and six month post-randomisation. Blinded assessors collected the outcome measures. Results 24 patients were randomised to control group, 26 to intervention group, mean age 77.6 (Range 62 to 92) years. We recruited 37.5% of eligible participants across the five clinical sites. 77% in the intervention group completed their full exercise programme (including the use of the app). Response rate for outcome measures at six months were 77%-80% across outcome measures, but this was effected by the COVID19 pandemic. There was a mean 2.6 ± 1.9 point difference between groups in change in BERG balance score from baseline to three months and mean 4.4 ± 2.7 point difference from baseline to six months in favour of the intervention group. Less falls (1.8 ± 2.8 vs 9.1 ± 32.6) and less injurious falls (0.1 ± 0.5 vs 0.4 ± 0.6) in the intervention group and higher adherence scores at three (17.7 ± 6.8 vs 13.1 ± 6.5) and six months (15.3 ± 7.8 vs 14.9 ± 7.8). There were no related adverse events. Health professionals and patients had few technical issues with the apps. Conclusions The motivational apps and trial procedures were feasible for health professionals and patients. There are positive indications from outcome measures in the feasibility trial and key criteria for progression to full trial were met.

引言
跌倒对生活质量、独立能力及医疗服务成本均具有重大影响。研究表明，只要严格遵循循证方案开展训练，力量与平衡训练可有效降低跌倒发生率与跌倒风险。本研究旨在达成两大目标：（1）评估在临床实践中应用"Motivate Me"与"My Activity Programme"干预措施辅助跌倒康复的可行性；（2）评估该干预措施评估所用的研究设计与试验流程。

方法
本研究针对英国5家医疗服务机构开展了一项双臂实用型可行性随机对照试验。研究招募了年龄≥50岁、符合社区跌倒康复训练项目纳入标准的患者，将其随机分为两组：（1）常规服务组：仅使用智能手机进行结局指标测量；（2）干预组：在常规服务基础上使用"Motivate Me"与"My Activity Programme"应用程序。本研究的主要结局为干预措施、研究设计及试验流程的可行性（包括招募率、依从性与脱落率）。结局指标涵盖平衡能力、躯体功能、跌倒情况、肌肉力量、跌倒恐惧、健康相关生活质量、资源利用与依从性，分别于随机化后基线、3个月及6个月进行评估。由设盲的评估人员负责收集所有结局指标数据。

结果
本研究共纳入50例患者，其中对照组24例，干预组26例，患者平均年龄为77.6岁（年龄范围62~92岁）。5家临床中心共招募了37.5%的符合入组标准的参与者。77%的干预组患者完成了全部训练项目（包括应用程序的使用）。6个月时各结局指标的应答率为77%~80%，但该数据受COVID-19（新型冠状病毒肺炎）疫情影响。从基线至3个月时，两组的BERG平衡评分变化均值相差2.6±1.9分；从基线至6个月时，两组差值为4.4±2.7分，均有利于干预组。干预组的跌倒次数更少（1.8±2.8 vs 9.1±32.6），致伤性跌倒次数也更少（0.1±0.5 vs 0.4±0.6），且在3个月（17.7±6.8 vs 13.1±6.5）与6个月（15.3±7.8 vs 14.9±7.8）时的依从性评分更高。本研究未发生与干预相关的不良事件。医疗专业人员与患者在使用该应用程序时仅遇到少量技术问题。

结论
本研究使用的激励类应用程序与试验流程对医疗专业人员及患者均具有可行性。可行性试验的结局指标显示出积极的干预效果，且满足推进至全规模试验的关键标准。