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临床试验/NCT06330714
NCT06330714已完成不适用

Remote Monitoring of Chronic Illness Patients (REMOTE-HUB-1) Study - to Assess Utility of a Mobile Device for Improved Management of At-risk Patients

Aventyn, Inc.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Aventyn, Inc.
入组人数
10
试验地点
1
主要终点
Mobile Home Device Hub Data Resiliency

研究概览

简要总结

This is planned as a feasibility study.

The primary objective is to evaluate a specially designed patient monitoring software Vitalbeat and standard mobile device hub termed Intel Health Application Platform (IHAP) in terms of its reliability, seamless data transmission and early data availability to the physician to improve patient physician interaction.

The second objective is assessing patient response to use of mobile device monitoring and patient self-monitoring skills to transmit vital signs data using the IHAP wireless home hub device

详细描述

The proposed study is a prospective single-center clinical feasibility study. All patients shall be monitored for a total period of 30 days from their date of recruitment. A total of 10 patients will be recruited from one center. The center will be provided with mobile devices which would be activated by a local mobile service provider. Additionally a tablet computer will be provided to the local investigator for monitoring patient's data, providing portability and immediate access of information. An automated blood pressure (BP) monitoring apparatus and a weighing scale will be provided to the patient.

Vitalbeat software, with a mobile device home hub having a specially designed patient personalized software application ("Vitalbeat" from Aventyn, USA) for remote monitoring and a clinician monitoring software will be tested in the proposed study. The software has been developed in a manner which provides easy navigation and use, with provision of regular data entry of basic parameters used in chronic illness monitoring. The entered data is instantaneously available on the software monitored at the physician's end.

This study is targeted towards chronic patients. A "chronic" patient is defined as a patient who has had within the last six months symptoms of chronic illness before enrollment.

All patients above 18 years hospitalized and discharged alive with a primary diagnosis of a chronic illness shall be considered for recruitment. Upon enrollment into the study, patients will have mobile device monitoring along with existing standard care monitoring available at the local center.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects of either gender and 18 years or older
  • The subject is able and willing to provide written informed consent prior to enrollment in the study
  • Symptoms of chronic illness.

排除标准

  • Disability of fingers or upper limbs (unable to use devices)
  • Visually impaired
  • Those unable to read and write
  • Hearing dysfunction
  • Significant cognitive disabilities / mental illness
  • Those who are unable to handle electronic devices
  • Those residing in places outside mobile phone coverage
  • Patients who may not come for follow up or likely to drop out of the study
  • Any illness which may preclude regular follow up

结局指标

主要结局

Mobile Home Device Hub Data Resiliency

时间窗: 30 Days

he primary objective is to evaluate a specially designed patient monitoring software and standard mobile device hub in terms of its reliability, seamless data transmission and early data availability to the physician to improve patient physician interaction once per day for 30 days.

次要结局

  • Patient Self Monitoring(30 Days)

研究者

发起方
Aventyn, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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