Shang Siyi, Cheng Shengguang, Qi Lingxia, Liu Tongtong, Yang Yuhan, Yao Xinuo, Lu Danyan, Cheng Xiaoyu, Yang Jing, Cheng Mei, Zhang Qinghua
Affiliated People's Hospital, Hangzhou Medical College, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China.
School of Medicine and Nursing Sciences, Huzhou University, Huzhou, Zhejiang, China.
BMJ Open. 2025 Apr 30;15(4):e082702. doi: 10.1136/bmjopen-2023-082702.
Accidental falls are a common geriatric syndrome that hinders healthy ageing in older adults. Older adults who live in nursing homes (NHs) are at a greater risk of accidental falls than those who reside in communities. Intrinsic capacity (IC) decline has been shown to be an independent influencing factor for fall risk. Moreover, healthy behaviour is a prerequisite for IC. Therefore, this study considers IC as a starting point, with an aim of developing, implementing and evaluating a low-administration-cost multidomain fall risk management intervention programme based on the Health Action Process Approach.
The target population includes older adults with declining IC in Chinese NHs. A random lottery method will be adopted to divide the 100 participants into the control group and intervention group. The project will be conducted in three parts over 24 weeks. In the first part, a fall risk management intervention pathway and programme will be developed with the theoretical and IC framework, which will be refined via the Delphi method. In the second part, a randomised controlled trial will be implemented. The control group will receive usual care and health education, and the intervention group will complete a three-stage process to complete fall risk management behaviour intention and behaviour maintenance. In the third part, follow-up will be conducted to clarify the maintenance effectiveness of the programme in fall risk management. Behaviour change techniques and an interactive handbook will be used to increase the feasibility of the programme. The primary outcomes will include the IC composite score (cognition, locomotion, vitality, sensation and psychology) and fall risk. The secondary outcomes will include gait and balance, strength, fall efficacy, fall prevention self-management, fall management behaviour stages and healthy ageing. The outcomes will be assessed at baseline, and then after 4 weeks, 16 weeks and 24 weeks in both groups. The effectiveness of the intervention will be analysed via linear mixed models on a range of outcomes.
The trial was approved by the Huzhou University Committee (No.2023-06-06). The results will be submitted for publication in a peer-reviewed journal and presented at conferences.
NCT05891782.
意外跌倒在老年人中是一种常见的老年综合征，会阻碍老年人的健康老龄化。居住在养老院的老年人比居住在社区的老年人意外跌倒的风险更高。内在能力（IC）下降已被证明是跌倒风险的一个独立影响因素。此外，健康行为是内在能力的一个先决条件。因此，本研究将内在能力作为出发点，旨在基于健康行动过程方法制定、实施和评估一个管理成本低的多领域跌倒风险管理干预项目。
目标人群包括中国养老院中内在能力下降的老年人。将采用随机抽签的方法将100名参与者分为对照组和干预组。该项目将在24周内分三个部分进行。第一部分，将利用理论和内在能力框架制定跌倒风险管理干预路径和项目，并通过德尔菲法进行完善。第二部分，将实施一项随机对照试验。对照组将接受常规护理和健康教育，干预组将完成一个三阶段过程，以完成跌倒风险管理行为意向和行为维持。第三部分，将进行随访，以阐明该项目在跌倒风险管理方面的维持效果。将使用行为改变技术和一本交互式手册来提高该项目的可行性。主要结局将包括内在能力综合评分（认知、运动、活力、感觉和心理）和跌倒风险。次要结局将包括步态和平衡、力量、跌倒效能、预防跌倒自我管理、跌倒管理行为阶段和健康老龄化。结局将在基线时进行评估，然后在两组中分别于4周、16周和24周后进行评估。将通过线性混合模型对一系列结局分析干预的有效性。
该试验已获得湖州大学委员会批准（编号：2023 - 06 - 06）。研究结果将提交至同行评审期刊发表，并在会议上展示。
NCT05891782。
