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OpenTrials
Completed

NCT Number: NCT06330714

Remote Monitoring of Chronic Illness Patients With a IHAP Home Wireless Hub and Vitals Measurements

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Liver Health

Chandler, Arizona, 85248, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Symptoms of chronic illness.

Other

The patient is advised to monitor BP and body weight daily in a standardized fashion as described below:

  • Body weight should be measured in the morning without clothes or shoes after emptying the urinary bladder but before breakfast.
  • BP should be measured in the morning preferably using the right arm, sitting comfortably in a chair after 5 minutes of rest in the seated position.

Primary outcomes

  1. Mobile Home Device Hub Data Resiliency

    Time frame: 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.

Secondary outcomes

  1. Patient Self Monitoring

    Time frame: 30 Days

    The second objective is assessing patient response to use of mobile device monitoring and patient self-monitoring skills to transmit vital signs data using a home hub device once per day for 30 days

Sponsors and collaborators

Lead sponsor

Aventyn, Inc.

Industry

Collaborators

  • Intel Corporation

Registry information

Official study title

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

Acronym: REMOTE-HUB-1

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 26, 2024
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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