Gerontopole, University Hospital of Toulouse, Toulouse, France.
Laboratoire d'analyse et d'architecture des systèmes, Centre national de la Recherche Scientifique, Toulouse, France.
JMIR Mhealth Uhealth. 2021 Jul 5;9(7):e15641. doi: 10.2196/15641.
Recent World Health Organization reports propose wearable devices to collect information on activity and walking speed as innovative health indicators. However, mainstream consumer-grade tracking devices and smartphone apps are often inaccurate and require long-term acceptability assessment.
Our aim is to assess the user acceptability of an instrumented shoe insole in frail older adults. This device monitors participants' walking speed and differentiates active walking from shuffling after step length calibration.
A multiphase evaluation has been designed: 9 older adults were evaluated in a living lab for a day, 3 older adults were evaluated at home for a month, and a prospective randomized trial included 35 older adults at home for 3 months. A qualitative research design using face-to-face and phone semistructured interviews was performed. Our hypothesis was that this shoe insole was acceptable in monitoring long-term outdoor and indoor walking. The primary outcome was participants' acceptability, measured by a qualitative questionnaire and average time of insole wearing per day. The secondary outcome described physical frailty evolution in both groups.
Living lab results confirmed the importance of a multiphase design study with participant involvement. Participants proposed insole modifications. Overall acceptability had mixed results: low scores for reliability (2.1 out of 6) and high scores for usability (4.3 out of 6) outcomes. The calibration phase raised no particular concern. During the field test, a majority of participants (mean age 79 years) were very (10/16) or quite satisfied (3/16) with the insole's comfort at the end of the follow-up. Participant insole acceptability evolved as follows: 63% (12/19) at 1 month, 50% (9/18) at 2 months, and 75% (12/16) at 3 months. A total of 9 participants in the intervention group discontinued the intervention because of technical issues. All participants equipped for more than a week reported wearing the insole every day at 1 month, 83% (15/18) at 2 months, and 94% (15/16) at 3 months for 5.8, 6.3, and 5.1 hours per day, respectively. Insole data confirmed that participants effectively wore the insole without significant decline during follow-up for an average of 13.5 days per 4 months and 5.6 hours per day. For secondary end points, the change in frailty parameters or quality of life did not differ for those randomly assigned to the intervention group compared to usual care.
Our study reports acceptability data on an instrumented insole in indoor and outdoor walking with remote monitoring in frail older adults under real-life conditions. To date, there is limited data in this population set. This thin instrumentation, including a flexible battery, was a technical challenge and seems to provide an acceptable solution over time that is valued by participants. However, users still raised certain acceptability issues. Given the growing interest in wearable health care devices, these results will be useful for future developments.
ClinicalTrials.gov NCT02316600; https://clinicaltrials.gov/ct2/show/NCT02316600.
世界卫生组织最近的报告提出，可穿戴设备可以收集有关活动和行走速度的信息，作为创新的健康指标。然而，主流的消费者级别的跟踪设备和智能手机应用程序通常不够准确，需要进行长期的可接受性评估。
我们旨在评估仪器化鞋底在体弱老年人中的用户可接受性。该设备监测参与者的行走速度，并在经过步长校准后区分主动行走和拖着脚走。
设计了多阶段评估：9 名老年人在生活实验室中进行了为期一天的评估，3 名老年人在家中进行了为期一个月的评估，前瞻性随机试验包括 35 名老年人在家中进行了为期 3 个月的评估。采用面对面和电话半结构化访谈的定性研究设计。我们的假设是，这种鞋底在监测长期户外和室内行走方面是可以接受的。主要结果是参与者的可接受性，通过定性问卷和每天平均佩戴鞋底的时间来衡量。次要结果描述了两组的身体虚弱演变。
生活实验室的结果证实了参与者参与的多阶段设计研究的重要性。参与者提出了鞋底的修改建议。整体可接受性的结果喜忧参半：可靠性得分（6 分中的 2.1 分）较低，可用性得分（6 分中的 4.3 分）较高。校准阶段没有引起特别关注。在现场测试中，大多数参与者（平均年龄 79 岁）在随访结束时对鞋底的舒适度非常（10/16）或相当满意（3/16）。参与者的鞋底可接受性如下变化：1 个月时为 63%（12/19），2 个月时为 50%（9/18），3 个月时为 75%（12/16）。干预组共有 9 名参与者因技术问题停止了干预。所有佩戴超过一周的参与者在 1 个月时报告每天都穿鞋底，83%（15/18）在 2 个月时，94%（15/16）在 3 个月时，分别为每天 5.8、6.3 和 5.1 小时。鞋底数据证实，参与者在随访期间有效地佩戴了鞋底，没有明显下降，平均每 4 个月佩戴 13.5 天，每天佩戴 5.6 小时。对于次要终点，与常规护理相比，随机分配到干预组的参与者的虚弱参数或生活质量变化没有差异。
我们的研究报告了在现实生活条件下，仪器化鞋底在体弱老年人的室内和户外行走以及远程监测中的可接受性数据。迄今为止，在这一人群中，数据有限。这种薄型仪器包括一个灵活的电池，这是一个技术挑战，随着时间的推移，似乎提供了一个可接受的解决方案，受到参与者的重视。然而，用户仍然提出了一些可接受性问题。鉴于对可穿戴式医疗设备的兴趣日益浓厚，这些结果将对未来的发展有用。
ClinicalTrials.gov NCT02316600；https://clinicaltrials.gov/ct2/show/NCT02316600。
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