Karlsson Åsa, Sönnerfors Pernilla, Lundell Sara, Toots Annika, Wadell Karin
Department of Community Medicine and Rehabilitation, Umeå University, Umeå, Sweden.
Department of Medicine Solna, Division of Immunology and Respiratory Medicine, Center for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden.
JMIR Form Res. 2025 Jun 23;9:e68195. doi: 10.2196/68195.
BACKGROUND: There is a growing interest in eHealth solutions to enhance access to and use of pulmonary rehabilitation for people with chronic obstructive pulmonary disease (COPD). OBJECTIVE: This study aims to evaluate the feasibility of a novel eHealth tool (Me&COPD) to support pulmonary rehabilitation concerning usability, exercise adherence, intensity, progression, and adverse events. Moreover, this study aims to evaluate clinical outcome measures to prepare for a future larger trial. METHODS: A multicenter, parallel-group randomized controlled pilot and feasibility trial was conducted in 6 primary health care centers. People with mild to severe COPD were recruited by physiotherapists at the included health care centers and randomized either to the intervention group with access to Me&COPD for 3 months or to the control group receiving usual care. The Me&COPD tool comprised audio-visual and written self-management strategies, including an individually tailored home-based exercise program and interaction with a physiotherapist. The exercise program was prescribed in a face-to-face meeting with a physiotherapist, and thereafter it was regularly reviewed and adjusted through the eHealth tool. The primary outcome, usability, was self-assessed at intervention completion in the intervention group and among participating physiotherapists (n=7) using the Swedish version of the Mobile Health App Usability Questionnaire (S-MAUQ). In addition, use data on exercise adherence, intensity, and progression and adverse events were exported from the eHealth tool. Clinical outcomes, assessed by blinded assessors at baseline and 3 months in the intervention and control groups, included exercise capacity, balance, physical activity level, COPD-related symptoms, and health-related quality of life. Descriptive statistics were used for analysis. RESULTS: In total, 22 participants (women: n=12, 55%), aged 72.3 (SD 8.4) years on average, were included in the intervention (n=15) and control (n=7) groups. The mean overall S-MAUQ scores out of 7 (highest possible usability) were 4.4 (SD 1.5) for participants and 4.5 (SD 1.2) for physiotherapists. Among the subscales, the highest score was assigned to usefulness among participants (S-MAUQ: mean 4.9, SD 1.3) and physiotherapists (S-MAUQ: mean 5.1, SD 1.7). No severe adverse events were registered, although exercise adherence, intensity, and progression evaluation were limited by incomplete exercise session registration. The test procedures and the clinical outcome measures used were found to be feasible for the participants and the assessors. CONCLUSIONS: The novel eHealth tool, Me&COPD, seemed feasible in terms of safety and had acceptable usability among people with COPD and participating physiotherapists. Usability may be improved by better organization of the information and simplification of the exercise diary to enable collection of data on exercise adherence, intensity, and progression through the eHealth tool. The test procedures seemed feasible, although the recruitment process needs further consideration. The effectiveness of the intervention remains to be evaluated in a future larger trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05086341; https://clinicaltrials.gov/study/NCT05086341.
背景:电子健康解决方案对于改善慢性阻塞性肺疾病(COPD)患者获得和使用肺康复服务的机会越来越受到关注。 目的:本研究旨在评估一种新型电子健康工具(Me&COPD)在支持肺康复方面的可行性,包括可用性、运动依从性、强度、进展情况和不良事件。此外,本研究旨在评估临床结局指标,为未来更大规模的试验做准备。 方法:在6个初级卫生保健中心进行了一项多中心、平行组随机对照试点和可行性试验。纳入的卫生保健中心的物理治疗师招募了轻至重度COPD患者,并将其随机分为干预组(可使用Me&COPD 3个月)或接受常规护理的对照组。Me&COPD工具包括视听和书面自我管理策略,包括个性化定制的居家锻炼计划以及与物理治疗师的互动。锻炼计划在与物理治疗师的面对面会议中制定,之后通过电子健康工具定期进行审查和调整。主要结局指标可用性在干预组干预结束时以及参与的物理治疗师(n = 7)中使用瑞典版移动健康应用程序可用性问卷(S-MAUQ)进行自我评估。此外,从电子健康工具中导出运动依从性、强度、进展情况和不良事件的使用数据。在干预组和对照组中,由盲法评估者在基线和3个月时评估的临床结局包括运动能力、平衡能力、身体活动水平、COPD相关症状以及健康相关生活质量。采用描述性统计进行分析。 结果:干预组(n = 15)和对照组(n = 7)共纳入22名参与者(女性:n = 12,55%),平均年龄72.3(标准差8.4)岁。参与者的S-MAUQ总分(满分7分,可用性最高)平均为4.4(标准差1.5),物理治疗师为4.5(标准差1.2)。在各子量表中,参与者(S-MAUQ:平均4.9,标准差1.3)和物理治疗师(S-MAUQ:平均5.1,标准差1.7)对有用性的评分最高。尽管运动依从性、强度和进展评估因锻炼课程登记不完整而受到限制,但未记录到严重不良事件。所使用的测试程序和临床结局指标对参与者和评估者来说似乎是可行的。 结论:新型电子健康工具Me&COPD在安全性方面似乎是可行的,在COPD患者和参与的物理治疗师中具有可接受的可用性。通过更好地组织信息和简化锻炼日记,以能够通过电子健康工具收集运动依从性、强度和进展数据,可用性可能会得到改善。测试程序似乎可行,尽管招募过程需要进一步考虑。干预的有效性仍有待在未来更大规模的试验中进行评估。 试验注册:ClinicalTrials.gov NCT05086341;https://clinicaltrials.gov/study/NCT05086341 。
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