Remote Monitoring of Chronic Illness Patients With a IHAP Home Wireless Hub and Vitals Measurements (REMOTE-HUB-1)

March 19, 2024 updated by: Aventyn, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85248
        • Institute for Liver Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aventyn, Inc.

Collaborators

Intel Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AV.RMH.v01-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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