Waterman Heather, Ballinger Claire, Brundle Caroline, Chastin Sebastien, Gage Heather, Harper Robert, Henson David, Laventure Bob, McEvoy Lisa, Pilling Mark, Olleveant Nicky, Skelton Dawn A, Stanford Penelope, Todd Chris
University of Cardiff, Eastgate House, 35-43 Newport Road, Cardiff, CF24 0AB, UK.
University of Southampton, Southampton, UK.
Trials. 2016 Sep 26;17(1):464. doi: 10.1186/s13063-016-1565-0.
Published evaluations of successful interventions to prevent falls in people with sight impairment (SI) are limited. The aim of this feasibility study is to optimise the design and investigation of home safety (HS) and home exercise (HE) programmes to prevent falls in older people with SI.
A community-based feasibility study in north-west England comprising a three-arm randomised controlled trial (RCT) allocated participants to (1) a control group receiving usual care and social visits, (2) an experimental group receiving the HS programme and (3) an experimental group receiving the HS + HE programme. Participants were community-dwelling, aged 65 years and older and sight impaired. Primary outcome data on falls were collected continuously over 6 months. Secondary outcomes on physical activity (self-report and instrumented) and adherence were collected at baseline and 3 and 6 months for HE and at 6 months for the HS programme. Costs for the HS and HS + HE groups were calculated from logs of time spent on home visits, telephone calls and travel. The research assistant and statistician were blinded to group allocation.
Altogether, 49 people were recruited over a 9-month period (randomised: 16 to control, 16 to HS, 17 to HS + HE). The interventions were implemented over 6 months by an occupational therapist at a cost per person (pounds sterling, 2011) of £249 (HS) and £674 (HS + HE). Eighty-eight percent (43/49) completed the trial and 6-month follow-up. At 6-month follow-up, 100 % reported partially or completely adhering to HS recommendations but evidence for adherence to HE was equivocal. Although self-reported physical activity increased, instrumented monitoring showed a decrease in walking activity. There were no statistically significant differences in falls between the groups; however, the study was not powered to detect a difference.
It is feasible and acceptable for an occupational therapist to deliver HS and HE falls prevention programmes to people with SI living independently in the community. Future studies could access Local Authority Registers of people with SI to improve recruitment rates. Further research is required to identify how to improve adherence to HE and to measure changes in physical activity before conducting a definitive RCT.
ISRCTN53433311 , registered on 8 May 2014.
已发表的关于预防视力障碍（SI）患者跌倒的成功干预措施的评估有限。本可行性研究的目的是优化家庭安全（HS）和家庭锻炼（HE）计划的设计与研究，以预防老年SI患者跌倒。
在英格兰西北部进行一项基于社区的可行性研究，包括一项三臂随机对照试验（RCT），将参与者分配到：（1）接受常规护理和社会探访的对照组；（2）接受HS计划的实验组；（3）接受HS + HE计划的实验组。参与者为社区居住的65岁及以上且有视力障碍的老年人。连续6个月收集跌倒的主要结局数据。在基线、3个月和6个月时收集HE的身体活动（自我报告和仪器监测）及依从性的次要结局数据，HS计划在6个月时收集。HS组和HS + HE组的成本根据家访、电话和出行所花费时间的记录进行计算。研究助理和统计学家对分组情况不知情。
在9个月期间共招募了49人（随机分组：16人至对照组，16人至HS组，17人至HS + HE组）。干预措施由一名职业治疗师在6个月内实施，每人成本（2011年英镑）为249英镑（HS组）和674英镑（HS + HE组）。88%（43/49）的人完成了试验及6个月随访。在6个月随访时，100%的人报告部分或完全遵守了HS建议，但关于遵守HE的证据不明确。尽管自我报告的身体活动增加，但仪器监测显示步行活动减少。各组之间跌倒情况无统计学显著差异；然而，该研究的效能不足以检测出差异。
职业治疗师为社区中独立生活的SI患者提供HS和HE跌倒预防计划是可行且可接受的。未来研究可查阅地方当局的SI患者登记册以提高招募率。在进行确定性RCT之前，需要进一步研究以确定如何提高对HE的依从性并测量身体活动的变化。
ISRCTN53433311，于2014年5月8日注册。
