个体定制化综合干预措施对改善养老院中伴有关节挛缩的居民的活动和参与度的有效性（JointConEval）：一项多中心实用型整群随机对照试验。

Effectiveness of an individually tailored complex intervention to improve activities and participation in nursing home residents with joint contractures (JointConEval): a multicentre pragmatic cluster-randomised controlled trial.

机构信息

Medical Faculty, Institute of Health and Nursing Sciences, Martin Luther University Halle-Wittenberg, Halle, Germany.

Faculty of Applied Health and Social Sciences, Rosenheim Technical University of Applied Sciences, Rosenheim, Germany.

出版信息

BMJ Open. 2023 Oct 29;13(10):e073363. doi: 10.1136/bmjopen-2023-073363.

DOI:10.1136/bmjopen-2023-073363

PMID:37899149

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10619003/

Abstract

OBJECTIVE

This study aims to examine the effects of the individually tailored complex intervention Participation Enabling Care in Nursing (PECAN) on activities and participation of residents with joint contractures.

DESIGN

Multicentre pragmatic cluster-randomised controlled trial.

SETTING

35 nursing homes in Germany (August 2018-February 2020).

PARTICIPANTS

562 nursing home residents aged ≥65 years with ≥1 major joint contracture (303 intervention group, 259 control group).

INTERVENTIONS

Nursing homes were randomised to PECAN (18 clusters) or optimised standard care (17 clusters) with researcher-concealed cluster allocation by facsimile. The intervention targeted impairments in activities and participation. Implementation included training and support for selected staff. Control group clusters received brief information.

PRIMARY AND SECONDARY OUTCOME MEASURES

The primary endpoint PaArticular Scales combined residents' activities and participation at 12 months. The secondary outcome comprised quality of life. Safety measures were falls, fall-related consequences and physical restraints. Residents, staff and researchers were unblinded. Data collection, data entry and statistical analysis were blinded. Primary analyses were intention-to-treat at cluster level and individual level using a generalised mixed-effect regression model and imputation of missing data.

RESULTS

Primary outcome analyses included 301 intervention group residents and 259 control group residents. The mean change on the Activities Scale was -1.47 points (SD 12.2) in the intervention group and 0.196 points (SD 12.5) in the control group and -3.87 points (SD 19.7) vs -3.18 points (SD 20.8) on the Participation Scale. The mean differences of changes between the groups were not statistically significant: Activities Scale: -1.72 (97.5% CI -6.05 to 2.61); Participation Scale: -1.24 (97.5% CI -7.02 to 4.45). We found no significant difference in the secondary outcome and no effects on safety measures.

CONCLUSION

The complex intervention did not improve the activities and participation of nursing home residents on the PaArticular Scales at 12 months. Current nursing conditions in Germany may hamper implementation.

TRIAL REGISTRATION NUMBER

DRKS00015185.

摘要

目的

本研究旨在探讨个体化定制的综合干预措施参与式赋权护理（PECAN）对患有关节挛缩的居民活动和参与能力的影响。

设计

多中心实用集群随机对照试验。

设置

德国 35 家养老院（2018 年 8 月至 2020 年 2 月）。

参与者

年龄≥65 岁且有≥1 处主要关节挛缩的 562 名养老院居民（303 名干预组，259 名对照组）。

干预措施

养老院采用传真机进行研究者设盲的集群随机分配，将 PECAN（18 个集群）或优化的标准护理（17 个集群）分配给干预组。干预措施针对活动和参与方面的障碍。实施包括对选定员工进行培训和支持。对照组集群接受简要信息。

主要和次要结局测量

主要结局指标 PaArticular 量表在 12 个月时结合了居民的活动和参与度。次要结局包括生活质量。安全措施包括跌倒、跌倒相关后果和身体约束。居民、工作人员和研究人员均未设盲。数据收集、数据录入和统计分析均设盲。主要分析是在集群水平和个体水平上进行意向治疗分析，使用广义混合效应回归模型和缺失数据的插补。

结果

主要结局分析纳入了 301 名干预组居民和 259 名对照组居民。干预组活动量表的平均变化为-1.47 分（12.2 分标准差），对照组为 0.196 分（12.5 分标准差），而参与量表的平均变化为-3.87 分（19.7 分标准差）与-3.18 分（20.8 分标准差）。两组间变化的平均差异无统计学意义：活动量表：-1.72（97.5%CI-6.05 至 2.61）；参与量表：-1.24（97.5%CI-7.02 至 4.45）。我们未发现次要结局有显著差异，也未发现安全措施有任何影响。