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接受造血细胞移植和 CAR-T 细胞治疗患者的可穿戴技术远程医疗(TEL-HEMATO 研究):前瞻性非干预性单中心研究

英文原题:Telemedicine With Wearable Technologies in Patients Undergoing Hematopoietic Cell Transplantation and Chimeric Antigen Receptor T-Cell Therapy (TEL-HEMATO Study): Prospective Noninterventional Single-Center Study.

查看英文原题

Telemedicine With Wearable Technologies in Patients Undergoing Hematopoietic Cell Transplantation and Chimeric Antigen Receptor T-Cell Therapy (TEL-HEMATO Study): Prospective Noninterventional Single-Center Study.

PubMed 2024/06/04(内容时间) JMIR Form Res Q2 · IF 2.4(JCR 2025)

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

中文摘要

接受造血细胞移植(HCT)或嵌合抗原受体(CAR)T 细胞疗法的血液系统恶性肿瘤患者,出院后面临发生严重临床并发症的风险。

TEL-HEMATO 研究旨在改进用于 HCT 或 CAR-T 细胞治疗患者出院后前 3 个月随访的远程医疗平台,并加入可穿戴设备。

2022 年 11 月至 2023 年 7 月期间,对 11 例因血液系统恶性肿瘤接受自体 HCT(n=2)、异基因 HCT(n=5)或 CAR-T 细胞疗法(n=4)的患者进行筛选。2 例患者入组后退出研究。远程医疗平台每日收集生命体征、躯体症状和生活质量评估,持续至出院后 3 个月。每位患者配发一部经临床验证的智能手表(ScanWatch)和数字体温计,并通过专用智能手机应用程序收集数据。由血液科医生或 HCT 和 CAR-T 细胞疗法专科护士通过网络平台每日审核数据。

通过 ScanWatch 测量的生命体征以中等至较高依从性成功收集:8/9(89%)患者记录了心率,9/9(100%)患者记录了血氧饱和度和每日步数,7/9(78%)患者记录了睡眠时长。但患者手动记录的体温依从性较低,仅 5/9(55%)患者完成。总体而言,5/9(55%)患者在应用程序中报告临床症状。研究入组时 8/9(89%)患者完成生活质量评估,到第 3 个月末降至 3/9(33%)。根据系统可用性量表评分,平台可用性被认为可接受,但患者报告了技术问题。

将可穿戴设备加入远程医疗临床平台,可能协同改善 HCT 和 CAR-T 细胞治疗患者监测;但平台未实现完全自动化,也缺乏专职远程医疗团队,仍是需要克服的主要局限。在真实世界环境中,这一点尤为重要,因为目标人群通常年龄较大、数字素养较低。

展开英文摘要原文

Patients with hematological malignancies receiving hematopoietic cell transplantation (HCT) or chimeric antigen receptor (CAR) T-cell therapy are at risk of developing serious clinical complications after discharge.

The aim of the TEL-HEMATO study was to improve our telehealth platform for the follow-up of patients undergoing HCT or CAR T-cell therapy during the first 3 months after discharge with the addition of wearable devices.

Eleven patients who received autologous (n=2) or allogeneic (n=5) HCT or CAR T-cell therapy (n=4) for hematological malignancies were screened from November 2022 to July 2023. Two patients discontinued the study after enrollment. The telehealth platform consisted of the daily collection of vital signs, physical symptoms, and quality of life assessment up to 3 months after hospital discharge. Each patient received a clinically validated smartwatch (ScanWatch) and a digital thermometer, and a dedicated smartphone app was used to collect these data. Daily revision of the data was performed through a web-based platform by a hematologist or a nurse specialized in HCT and CAR T-cell therapy.

Vital signs measured through ScanWatch were successfully collected with medium/high adherence: heart rate was recorded in 8/9 (89%) patients, oxygen saturation and daily steps were recorded in 9/9 (100%) patients, and sleeping hours were recorded in 7/9 (78%) patients. However, temperature recorded manually by the patients was associated with lower compliance, which was recorded in 5/9 (55%) patients. Overall, 5/9 (55%) patients reported clinical symptoms in the app. Quality of life assessment was completed by 8/9 (89%) patients at study enrollment, which decreased to 3/9 (33%) at the end of the third month. Usability was considered acceptable through ratings provided on the System Usability Scale. However, technological issues were reported by the patients.

While the addition of wearable devices to a telehealth clinical platform could have potentially synergic benefits for HCT and CAR T-cell therapy patient monitoring, noncomplete automation of the platform and the absence of a dedicated telemedicine team still represent major limitations to be overcome. This is especially true in our real-life setting where the target population generally comprises patients of older age with a low digital education level.

论文信息

作者
Hurtado L、Gonzalez Concepcion M、Flix-Valle A、Ruiz-Romeo M、Gonzalez-Rodriguez S、Peña M、Paviglianiti A、Pera Jambrina MA
单位
Clinical Hematology Department, Institut Català d'Oncologia, Hospital Duran i Reynals, Barcelona, Spain.Spain
期刊
JMIR formative research2024 Jun 4
原文标识
PubMed 38833696 · DOI 10.2196/55918