Glynn Lisa, Moloney Eddie, Lane Stephen, McNally Emma, Buckley Carol, McCann Margaret, McCabe Catherine
School of Nursing and Midwifery, University of Galway, Galway, Ireland.
Tallaght University Hospital, Dublin, Ireland.
JMIR Mhealth Uhealth. 2025 Apr 23;13:e56318. doi: 10.2196/56318.
Chronic obstructive pulmonary disease (COPD) negatively impacts clinical health outcomes, resulting in frequent exacerbations, increased hospitalizations, reduced physical activity, deteriorated quality of life, and diminished self-efficacy. Previous studies demonstrated that a self-management program tailored for adults with COPD improves self-management decisions, resulting in a positive effect on clinical health outcomes. Limitations of these studies include issues regarding heterogeneity among interventions used, patient population characteristics, outcome measures, and longitudinal studies. Limited studies focused on the use of a comprehensive self-management program using a smartphone app for adults with COPD over 12 months.
This study aimed to explore the effectiveness of a smartphone app self-management program and monthly phone calls compared with standard respiratory outpatient care on clinical health outcomes in adults with COPD.
This was a 3-arm parallel pilot randomized controlled trial (RCT) that included 92 participants. Participants were randomized into intervention arm 1, which included a self-management smartphone app and monthly phone calls (n=31); intervention arm 2, which included a self-management smartphone app (n=31); and arm 3, which was standard respiratory outpatient care (n=30). All arms received standard respiratory outpatient care. The primary outcome was a binary indicator equal to 1 if participants reported attendance to a general practitioner (GP) and or a hospital setting as a result of an exacerbation and 0 otherwise. This indicator was recorded at 6 months and 12 months from the baseline. Secondary outcomes included engagement, breathlessness, physical activity, health-related quality of life, and self-efficacy.
There was a statistically significant difference (P=.03), indicating fewer exacerbations in the intervention arm 2 compared with the control arm at 6 months in the hospital setting. The intervention arms had a statistically significant difference indicating a lower risk of developing an exacerbation at 6 months in both the GP (P=.01) and hospital setting (P=.006) compared to the control arm. Furthermore, intervention arm 1 demonstrated a statistically significant difference in exercise capacity at 6 and 12 months (P=.02 and P=.03). The intervention arm 2 illustrated a statistically significant difference in step count (P=.009) compared to the control arm. The majority of participants (60%, 33/55) used the app over the 12-month period.
This study demonstrated that a smartphone app self-management program had a positive effect on clinical health outcomes for participants with COPD in comparison to standard respiratory outpatient care. This study illustrated benefits such as reduced exacerbations resulting in fewer hospitalizations, improved exercise capacity, and physical activity among the intervention arms. This was a single-center study, which was limited in power to demonstrate significant effects on all measured outcomes but paves the way for a larger, fully powered multicenter trial exploring the effect of a smartphone app self-management program on clinical health outcomes in adults with COPD.
ClinicalTrials.gov NCT05061810; https://clinicaltrials.gov/study/NCT05061810.
慢性阻塞性肺疾病（COPD）对临床健康结局产生负面影响，导致频繁发作、住院次数增加、身体活动减少、生活质量恶化以及自我效能感降低。先前的研究表明，为成年COPD患者量身定制的自我管理计划可改善自我管理决策，从而对临床健康结局产生积极影响。这些研究的局限性包括所使用的干预措施、患者群体特征、结局指标以及纵向研究等方面的异质性问题。有限的研究关注了使用智能手机应用程序的综合自我管理计划对成年COPD患者长达12个月的影响。
本研究旨在探讨与标准呼吸门诊护理相比，智能手机应用程序自我管理计划及每月电话随访对成年COPD患者临床健康结局的有效性。
这是一项三臂平行先导随机对照试验（RCT），纳入了92名参与者。参与者被随机分为干预组1，包括自我管理智能手机应用程序及每月电话随访（n = 31）；干预组2，包括自我管理智能手机应用程序（n = 31）；以及组3，即标准呼吸门诊护理（n = 30）。所有组均接受标准呼吸门诊护理。主要结局是一个二元指标，如果参与者因病情加重而就诊于全科医生（GP）或医院，则该指标等于1，否则为0。该指标在基线后的6个月和12个月进行记录。次要结局包括参与度、呼吸困难、身体活动、健康相关生活质量和自我效能感。
在6个月时，干预组2与对照组相比，在医院环境中病情加重次数有统计学显著差异（P = 0.03），表明干预组2的病情加重次数更少。与对照组相比，干预组在6个月时在全科医生处（P = 0.01）和医院环境中（P = 0.006）病情加重的风险有统计学显著差异，表明风险更低。此外，干预组1在6个月和12个月时运动能力有统计学显著差异（P = 0.02和P = 0.03）。与对照组相比，干预组2的步数有统计学显著差异（P = 0.009）。在12个月期间，大多数参与者（60%，33/55）使用了该应用程序。
本研究表明，与标准呼吸门诊护理相比，智能手机应用程序自我管理计划对COPD参与者的临床健康结局有积极影响。本研究表明了一些益处，如病情加重次数减少导致住院次数减少、运动能力改善以及干预组的身体活动增加。这是一项单中心研究，在证明对所有测量结局有显著影响方面能力有限，但为一项更大规模、有充分效力的多中心试验铺平了道路，该试验将探索智能手机应用程序自我管理计划对成年COPD患者临床健康结局的影响。
ClinicalTrials.gov NCT05061810；https://clinicaltrials.gov/study/NCT05061810
