Heart FailureNCT02475577
Determine Return on Investment in Heart Failure Remote Monitoring Program
A study testing Peripherals with HealthInterlink technology in people with Heart Failure, run by NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH at 1 site in United States.
Trial summary
The study will test a hypothesis that the remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1) will have a higher return on investment compared to remote monitoring with nurse researcher follow-up telephone communication to study subject (on Blue… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Peripherals with HealthInterlink technology
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Aug 2017
- Phase
- Interventional
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Absence of significant vision, hearing, or other communication deficits
- English speaking;
- Capable and willing to give informed consent;
- Participated in the in-patient heart failure class within the last three months. Acceptable candidate for elective, non-emergent, remote monitoring as determined by ordering physician;
- Living in a private home;
- Hospital admission for Heart Failure or decompensation in the previous 12 months
Show all 12Show fewer
- New York Heart Association (NYHA) classes II-IV, as assigned by the nurse researcher, trained by a cardiologist
- Cardiac aetiology: ischaemic, idiopathic, hypertensive, or valvular
- Left ventricular ejection fraction <40% s an index of systolic dysfunction, combined or not with a left ventricular filling pattern supporting the presence of diastolic dysfunction, according to the American College of Cardiology/American Heart Association Guidelines for chronic heart failure.
- or
- NYHA class II-III who had an ejection fraction >40% and evidence of diastolic left ventricular dysfunction.
- Optional subject with a diagnosis of diabetes (indicated by HbA1c >7).
Who cannot join
- Currently involved in other investigational clinical trials (unless permission is granted by other study PI);
- Females who are pregnant, planning to become pregnant within 3 months, or lactating;
- Requirement for emergent placement other than private home (subject's condition would be compromised if there is a delay in placement).
- Myocardial infarction, revascularization or Implantable Cardioverter Defibrillator (ICD) implantation in the previous 6 months angina or objective myocardial ischaemia requiring future revascularization implanted ventricular or atrial pacemaker (except dual chamber ICD pacemakers with good sinus activity);
- End-stage heart failure requiring regular inotropic drug infusions;
- Chronic renal failure requiring dialysis treatment and
- Unstable angina.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NCH Healthcare System
Naples, Florida, 34102
Theresa L Morrison, PhD, 239-624-4384, theresa.morrison@nchmd.org
Laurie Zone-Smith, PhD, 239-624-4986, laurie.zonesmith@nchmd.org
About this study
Official title: A Prospective Randomized Controlled Trial to Determine Return on Investment in a Tablet/Smartphone-based Heart Failure Remote Monitoring Program
The study will test a hypothesis that the remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1) will have a higher return on investment compared to remote monitoring with nurse researcher follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2) and self-monitoring without intervention (Control).
Read the detailed description
The objective of this remote monitoring study is to evaluate return on investment and end-user clinical outcomes associated with the use of self-monitoring peripherals and tablet/smartphone-based Welch Allyn HealthInterlink technology without intervention (Control), HealthInterlink remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1), and HealthInterlink remote monitoring with nurse research assistant follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2 added to Intervention 1).
- Conditions
- Heart Failure
- Being tested
- Peripherals with HealthInterlink technology
- Keywords
- telemedicine, heart failure, home blood pressure monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripherals with HealthInterlink technologyDevice
Also called Welch Allyn, Blood Pressure monitor, Weight Scale, Pulse Oximeter
home remote monitoring
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Control: Peripherals with HealthInterlink technology will record and transmit data, without intervention. Subject is able to view graphed data, bring the HealthInterlink tablet/smartphone to the physician's office and share data with family/other caregiver. Receives: Device: Peripherals with HealthInterlink technology |
| Intervention 1 | Experimental | Intervention 1: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver. Receives: Device: Peripherals with HealthInterlink technology |
| Intervention 2 | Experimental | Intervention 2: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver, and a call will be placed by the nurse research assistant to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts). The physicians will have access to the subject's data on a web-based program. Receives: Device: Peripherals with HealthInterlink technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization)
31 days post discharge with a heart failure-related hospital re-hospitalization.
Measured: 31 days
Secondary outcomes (6)
Communication with healthcare provider or emergency department
Communication that resulted in unplanned healthcare provider office visits or visit to emergency department
Measured: 31 days
Number of non-conformity issues
Number of non-conformity telephone reminder texts, emails, and/or calls.
Measured: 31 days
Health-related quality of life Questionnaire
Health-related quality of life
Measured: 31 days
Subject satisfaction Questionnaire
Subject satisfaction for peripherals and HealthInterlink tablet/ smartphone judged to be reliable and robust, ease of use, time to complete testing and questionnaire, benefit that promoted better health
Measured: 31 days
Physician satisfaction Questionnaire
Physician satisfaction for peripherals and HealthInterlink tablet/ smartphone judged to be reliable and robust, ease of use of software, benefit that promoted better communication with subject.
Measured: 31 days
Cost of system and intervention per subjects
Economic viability of remote monitoring program based on daily cost of system and intervention per subjects in comparison with control and treatment groups.
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH
- Sponsor type
- University, hospital or other
- Collaborators
- Welch Allyn
- Responsible party
- Sponsor
- Investigators
- Theresa Morrison, PhD, Principal investigator, NCH Healthcare System Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475577
- Sponsor's protocol ID
- 15-001
- Status last verified
- Mar 2016
- First submitted
- 12 Jun 2015
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial to Determine Return on Investment in a Tablet/Smartphone-based Heart Failure Remote Monitoring Program
- ClinicalTrials.gov ID
- NCT02475577
- Acronym / sponsor ID
- 15-001
- Conditions
- Heart Failure
- Keywords
- telemedicine, heart failure, home blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCHUniversity, hospital or other
- Collaborators
- Welch Allyn
- Study start
- Jun 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 18 Jun 2015 (estimated)
- 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.
The study will test a hypothesis that the remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1) will have a higher return on investment compared to remote monitoring with nurse researcher follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2) and self-monitoring without intervention (Control).
Detailed description
The objective of this remote monitoring study is to evaluate return on investment and end-user clinical outcomes associated with the use of self-monitoring peripherals and tablet/smartphone-based Welch Allyn HealthInterlink technology without intervention (Control), HealthInterlink remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1), and HealthInterlink remote monitoring with nurse research assistant follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2 added to Intervention 1).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Device: Peripherals with HealthInterlink technologyControl: Peripherals with HealthInterlink technology will record and transmit data, without intervention. Subject is able to view graphed data, bring the HealthInterlink tablet/smartphone to the physician's office and share data with family/other caregiver. |
| Intervention 1 | Experimental | Device: Peripherals with HealthInterlink technologyIntervention 1: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver. |
| Intervention 2 | Experimental | Device: Peripherals with HealthInterlink technologyIntervention 2: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver, and a call will be placed by the nurse research assistant to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts). The physicians will have access to the subject's data on a web-based program. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Absence of significant vision, hearing, or other communication deficits
- English speaking;
- Capable and willing to give informed consent;
- Participated in the in-patient heart failure class within the last three months. Acceptable candidate for elective, non-emergent, remote monitoring as determined by ordering physician;
- Living in a private home;
Key exclusion criteria (7 listed)
- Currently involved in other investigational clinical trials (unless permission is granted by other study PI);
- Females who are pregnant, planning to become pregnant within 3 months, or lactating;
- Requirement for emergent placement other than private home (subject's condition would be compromised if there is a delay in placement).
- Myocardial infarction, revascularization or Implantable Cardioverter Defibrillator (ICD) implantation in the previous 6 months angina or objective myocardial ischaemia requiring future revascularization implanted ventricular or atrial pacemaker (except dual chamber ICD pacemakers with good sinus activity);
- End-stage heart failure requiring regular inotropic drug infusions;
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 |
|---|---|---|
| Peripherals with HealthInterlink technologyAlso: Welch Allyn, Blood Pressure monitor, Weight Scale, Pulse Oximeterhome remote monitoring | Device | Control, Intervention 1, Intervention 2 |
Primary outcome
Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization)
Time frame: 31 days
31 days post discharge with a heart failure-related hospital re-hospitalization.
6 secondary outcomes
Communication with healthcare provider or emergency department
Time frame: 31 days
Number of non-conformity issues
Time frame: 31 days
Health-related quality of life Questionnaire
Time frame: 31 days
Subject satisfaction Questionnaire
Time frame: 31 days
Physician satisfaction Questionnaire
Time frame: 31 days
Cost of system and intervention per subjects
Time frame: 31 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Healthcare system web siteLink provided by the sponsor.
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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.
Theresa Morrison, PhD principal investigator
NCH Healthcare System Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripherals with HealthInterlink technology in people with Heart Failure, run by NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH 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 12 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 31 Mar 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Theresa Morrison, PhD (239-624-4384, theresa.morrison@nchmd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization) (time frame: 31 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2016.