Remote Monitoring of Chronic Illness Patients With a IHAP Home Wireless Hub and Vitals Measurements (REMOTE-HUB-1)
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
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Arizona
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Chandler, Arizona, United States, 85248
- Institute for Liver Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
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
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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