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基于泛在感知的预防保健基础设施(PRECIOUS):一项研究方案。

PREventive Care Infrastructure based On Ubiquitous Sensing (PRECIOUS): A Study Protocol.

作者信息

Castellano-Tejedor Carmina, Moreno Jordi, Ciudin Andrea, Parramón Gemma, Lusilla-Palacios Pilar

机构信息

University Hospital Vall d'Hebron - Vall d'Hebron Research Institute, Department of Psychiatry, CIBERSAM, Autonomous University of Barcelona, Barcelona, Spain.

University Hospital Vall d'Hebron - Vall d'Hebron Research Institute, Department of Endocrinology, Diabetes and Associated Metabolic Disorders (Ciberdem), Instituto de Salud Carlos III, Autonomous University of Barcelona, Barcelona, Spain.

出版信息

JMIR Res Protoc. 2017 May 31;6(5):e105. doi: 10.2196/resprot.6973.

DOI:10.2196/resprot.6973
PMID:28566263
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5471342/
Abstract

BACKGROUND

mHealth has experienced a huge growth during the last decade. It has been presented as a new and promising pathway to increase self-management of health and chronic conditions in several populations. One of the most prolific areas of mHealth has been healthy lifestyles promotion. However, few mobile apps have succeeded in engaging people and ensuring sustained use.

OBJECTIVE

This paper describes the pilot test protocol of the PReventive Care Infrastructure based on Ubiquitous Sensing (PRECIOUS) project, aimed at validating the PRECIOUS system with end users. This system includes, within a motivational framework, the Bodyguard2 sensor (accelerometer with heart rate monitoring) and the PRECIOUS app.

METHODS

This is a pilot experimental study targeting morbidly obese prediabetic patients who will be randomized to three conditions: (1) Group 1 - Control group (Treatment as usual with the endocrinologist and the nurse + Bodyguard2), (2) Group 2 - PRECIOUS system (Bodyguard2 + PRECIOUS app), and (3) Group 3 - PRECIOUS system (Bodyguard2 + PRECIOUS app + Motivational Interviewing). The duration of the study will be 3 months with scheduled follow-up appointments within the scope of the project at Weeks 3, 5, 8, and 12. During the study, several measures related to healthy lifestyles, weight management, and health-related quality of life will be collected to explore the effectiveness of PRECIOUS to foster behavior change, as well as user acceptance, usability, and satisfaction with the solution.

RESULTS

Because of the encouraging results shown in similar scientific work analyzing health apps acceptance in clinical settings, we expect patients to widely accept and express satisfaction with PRECIOUS. We also expect to find acceptable usability of the preventive health solution. The recruitment of the pilot study has concluded with the inclusion of 31 morbidly obese prediabetic patients. Results are expected to be available in mid-2017.

CONCLUSIONS

Adopting and maintaining healthy habits may be challenging in people with chronic conditions who usually need regular support to ensure mid/long-term adherence to recommendations and behavior change. Thus, mHealth could become a powerful and efficient tool since it allows continuous communication with users and immediate feedback. The PRECIOUS system is an innovative preventive health care solution aimed at enhancing inner motivation from users to change their lifestyles and adopt healthier habits. PRECIOUS includes ubiquitous sensors and a scientifically grounded app to address three main components of health: physical activity, diet, and stress levels.

TRIAL REGISTRATION

Clinicaltrials.gov NCT02818790; https://clinicaltrials.gov/ct2/show/NCT02818790 (Archived by WebCite at http://www.webcitation.org/6qfzdfMoU).

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d547/5471342/64ba8c1f759b/resprot_v6i5e105_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d547/5471342/03a6034b9d60/resprot_v6i5e105_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d547/5471342/64ba8c1f759b/resprot_v6i5e105_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d547/5471342/03a6034b9d60/resprot_v6i5e105_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d547/5471342/64ba8c1f759b/resprot_v6i5e105_fig2.jpg
摘要

背景

在过去十年中,移动健康(mHealth)经历了巨大的发展。它被视为一种新的、有前景的途径,可用于提高多人群对健康和慢性病的自我管理能力。移动健康最活跃的领域之一是促进健康的生活方式。然而,很少有移动应用程序能够成功吸引用户并确保其持续使用。

目的

本文描述了基于泛在传感的预防性护理基础设施(PRECIOUS)项目的试点测试方案,旨在与终端用户一起验证PRECIOUS系统。该系统在一个激励框架内,包括保镖2传感器(带有心率监测功能的加速度计)和PRECIOUS应用程序。

方法

这是一项针对病态肥胖的糖尿病前期患者的试点实验研究,患者将被随机分为三种情况:(1)第1组——对照组(由内分泌科医生和护士进行常规治疗 + 保镖2),(2)第2组——PRECIOUS系统(保镖2 + PRECIOUS应用程序),(3)第3组——PRECIOUS系统(保镖2 + PRECIOUS应用程序 + 动机性访谈)。研究持续时间为3个月,在项目第3、5、8和12周安排随访预约。在研究期间,将收集与健康生活方式、体重管理和健康相关生活质量有关的多项指标,以探讨PRECIOUS促进行为改变的有效性,以及用户对该解决方案的接受度、可用性和满意度。

结果

鉴于在分析临床环境中健康应用程序接受度的类似科学研究中显示出令人鼓舞的结果,我们预计患者会广泛接受PRECIOUS并对其表示满意。我们还预计该预防性健康解决方案具有可接受的可用性。试点研究的招募工作已结束,共纳入31名病态肥胖的糖尿病前期患者。预计2017年年中可获得结果。

结论

对于患有慢性病的人来说,采用和维持健康习惯可能具有挑战性,他们通常需要定期支持以确保中长期坚持建议并改变行为。因此,移动健康可能成为一个强大而有效的工具,因为它允许与用户持续沟通并提供即时反馈。PRECIOUS系统是一种创新的预防性医疗保健解决方案,旨在增强用户改变生活方式和养成更健康习惯的内在动力。PRECIOUS包括泛在传感器和一个基于科学的应用程序,以解决健康的三个主要组成部分:身体活动、饮食和压力水平。

试验注册

Clinicaltrials.gov NCT02818790;https://clinicaltrials.gov/ct2/show/NCT02818790(由WebCite存档于http://www.webcitation.org/6qfzdfMoU)

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