Chronic Disease of Cardiovascular SystemREMOTE-HUB-1NCT06330714
Remote Monitoring of Chronic Illness Patients With a IHAP Home Wireless Hub and Vitals Measurements
An observational study of Chronic Disease of Cardiovascular System, run by Aventyn, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease of Cardiovascular System
- What is being tested?
- Symptoms of chronic illness.
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 30 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
Read the 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.
- Conditions
- Chronic Disease of Cardiovascular System
- Being tested
- Symptoms of chronic illness.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 Days
Secondary outcomes (1)
Patient Self Monitoring
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
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Jul 2018
- Primary completion30 Nov 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Disease of Cardiovascular SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aventyn, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Intel Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330714
- Sponsor's protocol ID
- AV.RMH.v01-01
- Acronym
- REMOTE-HUB-1
- Status last verified
- Mar 2024
- First submitted
- 28 Aug 2018
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24161453
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06330714
- Acronym / sponsor ID
- REMOTE-HUB-1 / AV.RMH.v01-01
- Conditions
- Chronic Disease of Cardiovascular System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Aventyn, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Intel Corporation
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptoms of chronic illness.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. | Other | – |
Primary outcome
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.
1 secondary outcome
Patient Self Monitoring
Time frame: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Background: PubMed 24161453Thorvaldsen 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.
- Abstract 18895: Utility of Remote Monitoring Using a Mobile Phone in Patients with Heart Failure: the REMOTE-HF-1 StudyLink provided by the sponsor.
- Assess Measurements of Wireless Cardiac Output Device (Remote-CO-1)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease of Cardiovascular System, run by Aventyn, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobile Home Device Hub Data Resiliency (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06330714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.