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一种通过智能手机应用程序(CareHand)提供的运动、教育和自我管理方案在手部类风湿关节炎成人患者中的应用:随机对照试验。

An Exercise and Educational and Self-management Program Delivered With a Smartphone App (CareHand) in Adults With Rheumatoid Arthritis of the Hands: Randomized Controlled Trial.

机构信息

Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Seville, Spain.

Uncertainty, Mindfulness, Self, Spirituality (UMSS) Research Group, University of Seville, Seville, Spain.

出版信息

JMIR Mhealth Uhealth. 2022 Apr 7;10(4):e35462. doi: 10.2196/35462.

Abstract

BACKGROUND

Rheumatoid arthritis (RA) is a prevalent autoimmune disease that usually involves problems of the hand or wrist. Current evidence recommends a multimodal therapy including exercise, self-management, and educational strategies. To date, the efficacy of this approach, as delivered using a smartphone app, has been scarcely investigated.

OBJECTIVE

This study aims to assess the short- and medium-term efficacy of a digital app (CareHand) that includes a tailored home exercise program, together with educational and self-management recommendations, compared with usual care, for people with RA of the hands.

METHODS

A single-blinded randomized controlled trial was conducted between March 2020 and February 2021, including 36 participants with RA of the hands (women: 22/36, 61%) from 2 community health care centers. Participants were allocated to use the CareHand app, consisting of tailored exercise programs, and self-management and monitoring tools or to a control group that received a written home exercise routine and recommendations, as per the usual protocol provided at primary care settings. Both interventions lasted for 3 months (4 times a week). The primary outcome was hand function, assessed using the Michigan Hand Outcome Questionnaire (MHQ). Secondary measures included pain and stiffness intensity (visual analog scale), grip strength (dynamometer), pinch strength (pinch gauge), and upper limb function (shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire). All measures were collected at baseline and at a 3-month follow-up. Furthermore, the MHQ and self-reported stiffness were assessed 6 months after baseline, whereas pain intensity and scores on the shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire were collected at the 1-, 3-, and 6-month follow-ups.

RESULTS

In total, 30 individuals, corresponding to 58 hands (CareHand group: 26/58, 45%; control group: 32/58, 55%), were included in the analysis; 53% (19/36) of the participants received disease-modifying antirheumatic drug treatment. The ANOVA demonstrated a significant time×group effect for the total score of the MHQ (F=9.163; P<.001; η=0.15) and for several of its subscales: overall hand function, work performance, pain, and satisfaction (all P<.05), with mean differences between groups for the total score of 16.86 points (95% CI 8.70-25.03) at 3 months and 17.21 points (95% CI 4.78-29.63) at 6 months. No time×group interaction was observed for the secondary measures (all P>.05).

CONCLUSIONS

Adults with RA of the hands who used the CareHand app reported better results in the short and medium term for overall hand function, work performance, pain, and satisfaction, compared with usual care. The findings of this study suggest that the CareHand app is a promising tool for delivering exercise therapy and self-management recommendations to this population. Results must be interpreted with caution because of the lack of efficacy of the secondary outcomes.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04263974; https://clinicaltrials.gov/ct2/show/NCT04263974.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04713-4.

摘要

背景

类风湿关节炎(RA)是一种常见的自身免疫性疾病,通常涉及手部或腕部的问题。目前的证据推荐采用包括运动、自我管理和教育策略在内的多模式治疗。迄今为止,使用智能手机应用程序提供这种方法的疗效还鲜有研究。

目的

本研究旨在评估一款数字应用程序(CareHand)的短期和中期疗效,该应用程序包括针对手部 RA 的量身定制的家庭运动方案,以及教育和自我管理建议,与常规护理相比,用于手部 RA 患者。

方法

这是一项于 2020 年 3 月至 2021 年 2 月期间进行的单盲随机对照试验,纳入了来自 2 个社区医疗保健中心的 36 名手部 RA 患者(女性:22/36,61%)。参与者被分配使用 CareHand 应用程序,包括量身定制的运动方案以及自我管理和监测工具,或使用常规护理提供的书面家庭运动方案和建议的对照组。两种干预措施均持续 3 个月(每周 4 次)。主要结局是手部功能,使用密歇根手部结果问卷(MHQ)评估。次要测量指标包括疼痛和僵硬强度(视觉模拟量表)、握力(测力计)、捏力(捏力计)和上肢功能(手臂、肩部和手残疾问卷的简化版)。所有测量均在基线和 3 个月随访时进行。此外,6 个月后还评估了 MHQ 和自我报告的僵硬程度,而疼痛强度和手臂、肩部和手残疾问卷简化版的评分则在 1、3 和 6 个月随访时收集。

结果

共有 30 名参与者(58 只手),对应于 58 只手(CareHand 组:26/58,45%;对照组:32/58,55%),被纳入分析;53%(19/36)的参与者接受了改善病情的抗风湿药物治疗。方差分析显示 MHQ 总分(F=9.163;P<.001;η=0.15)和其几个亚量表(总体手部功能、工作表现、疼痛和满意度)存在显著的时间×组效应(均 P<.05),组间差异在 3 个月时为 16.86 分(95%CI 8.70-25.03),在 6 个月时为 17.21 分(95%CI 4.78-29.63)。次要测量指标未见时间×组间交互作用(均 P>.05)。

结论

与常规护理相比,使用 CareHand 应用程序的手部 RA 成年患者在短期和中期的整体手部功能、工作表现、疼痛和满意度方面报告的结果更好。本研究结果表明,CareHand 应用程序是为该人群提供运动疗法和自我管理建议的有前途的工具。由于次要结局缺乏疗效,结果必须谨慎解释。

临床试验注册

ClinicalTrials.gov NCT04263974;https://clinicaltrials.gov/ct2/show/NCT04263974。

国际注册报告标识符(IRRID):RR2-10.1186/s13063-020-04713-4。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6b56/9030995/2eeb6abf115a/mhealth_v10i4e35462_fig1.jpg

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