Heart FailureICORNCT01495078
Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.
A study testing Telemonitoring in people with Heart Failure, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The primary objective of the study is to determine the effect of automated daily selfreported symptom and weight, blood pressure and heart rate monitoring and clinical follow-up videoconference comigrate with clinical follow-up face in specialized hospital unit in reducing heart failure non-fatal events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Telemonitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2010to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients discharged from a heart failure hospitalization within 30 days of enrollment into the study.
Who cannot join
- Less than 18 years
- Long-term nursing home residence, irreversible medical conditions, Folstein Mini-mental State Exam score less than 20.
- No access to 3G line, currently scheduled for cardiac transplant, left ventricular assist device or valvular surgery,coronary intervention within 90 days of randomisation.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of the study is to determine the effect of automated daily selfreported symptom and weight, blood pressure and heart rate monitoring and clinical follow-up videoconference comigrate with clinical follow-up face in specialized hospital unit in reducing heart failure non-fatal events.
Read the detailed description
The insuficie 'ncia Cardı´aca Optimitzacio ´ Remota (iCOR; Heart Failure Remote Optimization) trial was a singlecentre, randomized, open-label study designed to evaluate the efficacy of the addition of telemedicine (telemonitorization and teleintervention using videoconference) to an existing specialized, multidisciplinary, nurse-based, hospitalprimary care integrated HF programme for high-risk patients with CHF. The organizational characteristics of the programme and the impact in health outcomes resulting from its implementation have been previously published.2 In this study we aimed to compare the strategy of providing nurse-based structured follow-up to high-risk CHF patients through planned contacts between health care providers and patients and/or caregivers in the basis of face-to-face on-site encounters (usual care in our HF programme) or provide the planned care using telemedicine with the combination of remote daily monitoring of signs and symptoms of HF (telemonitoring) and delivery of structured nursebased follow-up health care using videoconference (teleintervention). The main hypothesis of this study was that adding telemedicine to an existing HF programme would be associated with a reduction in the number of non-fatal HF events in high-risk patients with CHF. As a secondary hypothesis we assumed that adding telemedicine would translate into a reduction in health care resource utilization and subsequently in health care costs.
- Conditions
- Heart Failure
- Being tested
- Telemonitoring
- Keywords
- telemonitoring, heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringProcedure or surgery
Is a computer system designed jointly by engineers and clinical personal of Parc Salut Mar) to be able daily automated selfreported symptom and weight, blood pressure and heart rate monitoring . The system allow weekly follow up throught videoconferences.
Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians and nurses.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring | Experimental | Patients with follow-up telemonitoring Receives: Procedure: Telemonitoring |
| Non - telemonitoring | No intervention | Patients with usual face follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non fatal events
Non fatal events are defined as an event of descompensation requiring either parenteral treatment as outpatients in a day hospital an in the emergency department or by income.
Measured: Six months after inclusion of the patient.
Secondary outcomes (2)
Morbid mortality
Measured: From telemonitoring (baseline) until six months later
Hospital readmission
Measured: From telemonitoring (baseline) until six months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2013
- Study completionDec 2014
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Comín, Parc de Salut Mar
- Investigators
- JOSEP COMIN COLET, MD, Principal investigator, HOSPITAL DEL MAR MEDICAL RESEARCH INSTITUTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495078
- Sponsor's protocol ID
- Proyecto ICOR
- Acronym
- ICOR
- Status last verified
- Feb 2016
- First submitted
- 8 Sep 2011
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.
- ClinicalTrials.gov ID
- NCT01495078
- Acronym / sponsor ID
- ICOR / Proyecto ICOR
- Conditions
- Heart Failure
- Keywords
- telemonitoring, heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Dec 2011 (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 primary objective of the study is to determine the effect of automated daily selfreported symptom and weight, blood pressure and heart rate monitoring and clinical follow-up videoconference comigrate with clinical follow-up face in specialized hospital unit in reducing heart failure non-fatal events.
Detailed description
The insuficie 'ncia Cardı´aca Optimitzacio ´ Remota (iCOR; Heart Failure Remote Optimization) trial was a singlecentre, randomized, open-label study designed to evaluate the efficacy of the addition of telemedicine (telemonitorization and teleintervention using videoconference) to an existing specialized, multidisciplinary, nurse-based, hospitalprimary care integrated HF programme for high-risk patients with CHF. The organizational characteristics of the programme and the impact in health outcomes resulting from its implementation have been previously published.2 In this study we aimed to compare the strategy of providing nurse-based structured follow-up to high-risk CHF patients through planned contacts between health care providers and patients and/or caregivers in the basis of face-to-face on-site encounters (usual care in our HF programme) or provide the planned care using telemedicine with the combination of remote daily monitoring of signs and symptoms of HF (telemonitoring) and delivery of structured nursebased follow-up health care using videoconference (teleintervention). The main hypothesis of this study was that adding telemedicine to an existing HF programme would be associated with a reduction in the number of non-fatal HF events in high-risk patients with CHF. As a secondary hypothesis we assumed that adding telemedicine would translate into a reduction in health care resource utilization and subsequently in health care costs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Experimental | Procedure: TelemonitoringPatients with follow-up telemonitoring |
| Non - telemonitoring | No intervention | –Patients with usual face follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients discharged from a heart failure hospitalization within 30 days of enrollment into the study.
Key exclusion criteria (3 listed)
- Less than 18 years
- Long-term nursing home residence, irreversible medical conditions, Folstein Mini-mental State Exam score less than 20.
- No access to 3G line, currently scheduled for cardiac transplant, left ventricular assist device or valvular surgery,coronary intervention within 90 days of randomisation.
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 |
|---|---|---|
| TelemonitoringIs a computer system designed jointly by engineers and clinical personal of Parc Salut Mar) to be able daily automated selfreported symptom and weight, blood pressure and heart rate monitoring . The system allow weekly follow up throught videoconferences. Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians and nurses. | Procedure or surgery | Telemonitoring |
Primary outcome
Non fatal events
Time frame: Six months after inclusion of the patient.
Non fatal events are defined as an event of descompensation requiring either parenteral treatment as outpatients in a day hospital an in the emergency department or by income.
2 secondary outcomes
Morbid mortality
Time frame: From telemonitoring (baseline) until six months later
Hospital readmission
Time frame: From telemonitoring (baseline) until six months later
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 17 Feb 2016.
- Individual participant dataSharing planned: No
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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.
JOSEP COMIN COLET, MD principal investigator
HOSPITAL DEL MAR MEDICAL RESEARCH INSTITUTE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring in people with Heart Failure, run by Parc de Salut Mar at 1 site in Spain.
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 1 inclusion and 3 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 17 Feb 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 Spain. 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?
Non fatal events (time frame: Six months after inclusion of the patient.). 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 17 Feb 2016.