Heart FailureNCT02936050
Telemedicine for Ultrasound Support in Nurse-based Outpatient Heart Failure Clinic
A study testing Diagnostic ultrasound in people with Heart Failure, run by Helse Nord-Trøndelag HF at 1 site in Norway.
Trial summary
The cost related to management of heart failure is significant, both with respect to the financial costs and the suffer of patients. Still as much as 50% of heart failure patients are readmitted within 6 months after hospitalization for decompensated heart failure. 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?
- Diagnostic ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2016to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure patients at the outpatient heart failure clinic at Levanger Hospital, which have consented to participate in the study.
Who cannot join
- As for inclusion, when the patient is not able to consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Ultrasound Diagnostics for Clinical Decision Making at Remote Locations - Data From an Outpatient Heart Failure Clinic
The cost related to management of heart failure is significant, both with respect to the financial costs and the suffer of patients. Still as much as 50% of heart failure patients are readmitted within 6 months after hospitalization for decompensated heart failure.
Specialized nurses have a growing role in diagnostics and follow-up of outpatient HF patients, and adding ultrasound diagnostics to the nurses consultations may improve care. In heart failure patients the use of ultrasound as a tool for assessing volume status and guidance of diuretic therapy are promising. Aim of the study is to evaluate the feasibility and reliability of echocardiographic acquisitions by heart failure nurses to assess cardiac function indices and assess volume status in outpatient heart failure clinics combined with a telemedicine approach for near real-time interpretation of the recordings by a cardiologist specialized in echocardiography and heart failure at a remote location.
Read the detailed description
The worsening heart failure epidemic is a significant driver of health care expenditure with increasing costs, lost productivity and increased suffer of patients. Thus, there important to develop strategies to improve heart failure care and reduce hospital readmissions. Some progress in heart failure management has been made with new drug therapies and remote monitoring of patients with heart failure.
This project aims to provide data which may add to the existing literature regarding the use of telemedicine for safe transfer of ultrasound data of relatively inexperienced users for qualitative and quantitative interpretation by experts at a different location. The authors will study whether diffusion of focused cardiac ultrasound to outpatient heart failure clinics with support of cardiologist provided by telemedicine is feasible and provides reliable data. Firstly, the investigators will study the use of high-end ultrasound machines connected to a wired broadband network with a CE-classified software providing safety and anonymization of all transferred data.
This project could be of significant importance for further support for widening the use of ultrasound diagnostics, even when the expert is not at the same location as the health-care provider performing the ultrasound acquisition. For the patients this may allow for better and faster diagnostics, and thus treatment. For the health-care system this may both improve quality of diagnostics and therapy, and be cost-saving as well. Lastly, this could make the way for further innovations which again can improve diagnostics and thus therapy.
Aims
- To study the feasibility of implementing focused echocardiography and ultrasound examinations to assess volume status in a heart failure clinic where the caregiving nurses acquire the ultrasound images but have access to the near real-time interpretation by the cardiologist only by telemedicine.
- To study the reliability of the measurements of cardiac size and function indices in ultrasound recordings acquired by heart failure nurses, provided to another location for interpretation by cardiologists by telemedicine, in comparison to reference imaging.
- To study the clinical influence of implementing ultrasound examinations performed by nurses to assess volume status and cardiac function at outpatient heart failure clinics when the support and collaboration with the specialist is available by telemedicine only.
- Conditions
- Heart Failure
- Being tested
- Diagnostic ultrasound
- Keywords
- Echocardiography, Telemedicine, Nurses, Decision support, eHealth
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic ultrasoundProcedure or surgery
Also called Echocardiography
All participants will be examined by diagnostic ultrasound by nurses for the assessment of the Cardiac size and function, and for volumic state. Transmission of the ultrasound recordings by telemedicine and interpretation by specialist in echocardiography and heart failure. All participants will then be examined by reference imaging in specific ultrasound laboratories.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Experimental: Addition of diagnostic ultrasound performed by nurses at the outpatient heart failure clinic. Interpretation by specialist per telemedicine.
No Control arm Receives: Procedure: Diagnostic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of diagnostic ultrasound examinations using support by telemedicine
Reliability (accuracy) will be tested with C-statistics of ultrasound performed by nurses at an outpatient heart failure clinic, with interpretation by telemedicine support of cardiologist compared to Reference imaging by specialists in cardiology
Measured: Reliability will be tested on day 0 (time of study inclusion)
Secondary outcomes (5)
Feasibility of echocardiography performed by nurses with support by telemedicine
Feasibility, as the proportion of recordings, of echocardiographic images with telemedicine interpretation of the echocardiographic recordings. Specified will we evaluate the proportion of exams that is successfully recorded by the nurses, then transmitted by and, at last, interpretated by telemedicine approach.
Measured: Feasibility will be tested on day 0 (time of study inclusion)
Time use of echocardiography performed by nurses with support by telemedicine
Time used for the sum of recording of echocardiographic images by the nurses, uploading for transferral and, at last, interpretation by telemedicine approach.
Measured: Feasibility will be tested on day 0 (time of study inclusion)
Quality of echocardiography performed by nurses with support by telemedicine
Evaluation of the quality of recordings of echocardiographic images obtained by the nurses as a semiquantitative score reflecting the whole examination compared to the reference images by the cardiologist.
Measured: Quality will be tested on day 0 (time of study inclusion)
Classification of type of heart failure by echocardiography by nurses with near real-time support by telemedicine
Comparison of classification of type of heart failure (reduced ejection fraction, mildly reduced ejection fraction or preserved ejection fraction) by the telemedicine approach compared to reference imaging.
reference echocardiography by cardiologist
Measured: Classification of type of heart failure by will be tested on day 0 (time of study inclusion)
Evaluation of volume status with echocardiography by nurses with near real-time support by telemedicine
Comparison of volume status (classified individually by a score based on dimension and respiratory variation of the inferior vena cava, visual and Doppler echocardiography and quantification of pleural effusion) by the telemedicine approach compared to reference imaging by cardiologist
Measured: Evaluation of volume status will be tested on day 0 (time of study inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017
- Study completionJan 2017
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Havard Dalen, MD, PhD, Principal investigator, Helse Nord-Trøndelag HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936050
- Sponsor's protocol ID
- LH_2016-1
- Status last verified
- Nov 2021
- First submitted
- 26 Sep 2016
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Ultrasound Diagnostics for Clinical Decision Making at Remote Locations - Data From an Outpatient Heart Failure Clinic
- ClinicalTrials.gov ID
- NCT02936050
- Acronym / sponsor ID
- LH_2016-1
- Conditions
- Heart Failure
- Keywords
- Echocardiography, Telemedicine, Nurses, Decision support, eHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 18 Oct 2016 (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 cost related to management of heart failure is significant, both with respect to the financial costs and the suffer of patients. Still as much as 50% of heart failure patients are readmitted within 6 months after hospitalization for decompensated heart failure.
Specialized nurses have a growing role in diagnostics and follow-up of outpatient HF patients, and adding ultrasound diagnostics to the nurses consultations may improve care. In heart failure patients the use of ultrasound as a tool for assessing volume status and guidance of diuretic therapy are promising. Aim of the study is to evaluate the feasibility and reliability of echocardiographic acquisitions by heart failure nurses to assess cardiac function indices and assess volume status in outpatient heart failure clinics combined with a telemedicine approach for near real-time interpretation of the recordings by a cardiologist specialized in echocardiography and heart failure at a remote location.
Detailed description
The worsening heart failure epidemic is a significant driver of health care expenditure with increasing costs, lost productivity and increased suffer of patients. Thus, there important to develop strategies to improve heart failure care and reduce hospital readmissions. Some progress in heart failure management has been made with new drug therapies and remote monitoring of patients with heart failure.
This project aims to provide data which may add to the existing literature regarding the use of telemedicine for safe transfer of ultrasound data of relatively inexperienced users for qualitative and quantitative interpretation by experts at a different location. The authors will study whether diffusion of focused cardiac ultrasound to outpatient heart failure clinics with support of cardiologist provided by telemedicine is feasible and provides reliable data. Firstly, the investigators will study the use of high-end ultrasound machines connected to a wired broadband network with a CE-classified software providing safety and anonymization of all transferred data.
This project could be of significant importance for further support for widening the use of ultrasound diagnostics, even when the expert is not at the same location as the health-care provider performing the ultrasound acquisition. For the patients this may allow for better and faster diagnostics, and thus treatment. For the health-care system this may both improve quality of diagnostics and therapy, and be cost-saving as well. Lastly, this could make the way for further innovations which again can improve diagnostics and thus therapy.
Aims
- To study the feasibility of implementing focused echocardiography and ultrasound examinations to assess volume status in a heart failure clinic where the caregiving nurses acquire the ultrasound images but have access to the near real-time interpretation by the cardiologist only by telemedicine.
- To study the reliability of the measurements of cardiac size and function indices in ultrasound recordings acquired by heart failure nurses, provided to another location for interpretation by cardiologists by telemedicine, in comparison to reference imaging.
- To study the clinical influence of implementing ultrasound examinations performed by nurses to assess volume status and cardiac function at outpatient heart failure clinics when the support and collaboration with the specialist is available by telemedicine only.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Procedure: Diagnostic ultrasoundExperimental: Addition of diagnostic ultrasound performed by nurses at the outpatient heart failure clinic. Interpretation by specialist per telemedicine. No Control arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Heart failure patients at the outpatient heart failure clinic at Levanger Hospital, which have consented to participate in the study.
Key exclusion criteria (1 listed)
- As for inclusion, when the patient is not able to consent.
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 |
|---|---|---|
| Diagnostic ultrasoundAlso: EchocardiographyAll participants will be examined by diagnostic ultrasound by nurses for the assessment of the Cardiac size and function, and for volumic state. Transmission of the ultrasound recordings by telemedicine and interpretation by specialist in echocardiography and heart failure. All participants will then be examined by reference imaging in specific ultrasound laboratories. | Procedure or surgery | Intervention |
Primary outcome
Reliability of diagnostic ultrasound examinations using support by telemedicine
Time frame: Reliability will be tested on day 0 (time of study inclusion)
Reliability (accuracy) will be tested with C-statistics of ultrasound performed by nurses at an outpatient heart failure clinic, with interpretation by telemedicine support of cardiologist compared to Reference imaging by specialists in cardiology
5 secondary outcomes
Feasibility of echocardiography performed by nurses with support by telemedicine
Time frame: Feasibility will be tested on day 0 (time of study inclusion)
Time use of echocardiography performed by nurses with support by telemedicine
Time frame: Feasibility will be tested on day 0 (time of study inclusion)
Quality of echocardiography performed by nurses with support by telemedicine
Time frame: Quality will be tested on day 0 (time of study inclusion)
Classification of type of heart failure by echocardiography by nurses with near real-time support by telemedicine
Time frame: Classification of type of heart failure by will be tested on day 0 (time of study inclusion)
Evaluation of volume status with echocardiography by nurses with near real-time support by telemedicine
Time frame: Evaluation of volume status will be tested on day 0 (time of study inclusion)
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 9 Nov 2021.
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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.
Havard Dalen, MD, PhD principal investigator
Helse Nord-Trøndelag HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic ultrasound in people with Heart Failure, run by Helse Nord-Trøndelag HF at 1 site in Norway.
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 1 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 9 Nov 2021. 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 Norway. 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?
Reliability of diagnostic ultrasound examinations using support by telemedicine (time frame: Reliability will be tested on day 0 (time of study inclusion)). 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 9 Nov 2021.