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

NCT06330714 | Completed

• 1 other identifier: AV.RMH.v01-01
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Disease of Cardiovascular System

Outcome Measures

Primary Outcomes (1)

• Mobile Home Device Hub Data Resiliency

  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 Outcomes (1)

• Patient Self Monitoring

  30 Days

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aventyn, Inc.: lead
• Intel Corporation: collaborator

Study Sites (1)

Institute for Liver Health

Chandler, Arizona, 85248, United States

Location

Related Publications (1)

• Thorvaldsen T, Benson L, Stahlberg M, Dahlstrom U, Edner M, Lund LH. Triage of patients with moderate to severe heart failure: who should be referred to a heart failure center? J Am Coll Cardiol. 2014 Feb 25;63(7):661-671. doi: 10.1016/j.jacc.2013.10.017. Epub 2013 Oct 30.

  PMID: 24161453 BACKGROUND

Related Links

• Assess Measurements of Wireless Cardiac Output Device (Remote-CO-1)

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: March 26, 2024
• Study Start: July 1, 2018
• Primary Completion: November 30, 2018
• Study Completion: December 30, 2018
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

US (1)