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Telemedicine for Ultrasound Support in Nurse-based Outpatient Heart Failure Clinic

NCT ID: NCT02936050

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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

1. 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.
2. 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.
3. 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

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Heart Failure

Keywords

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Echocardiography Telemedicine Nurses Decision support eHealth

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention

Experimental: Addition of diagnostic ultrasound performed by nurses at the outpatient heart failure clinic. Interpretation by specialist per telemedicine.

No Control arm

Group Type OTHER

Diagnostic ultrasound

Intervention Type PROCEDURE

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.

Interventions

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Diagnostic ultrasound

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.

Intervention Type PROCEDURE

Other Intervention Names

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Echocardiography

Eligibility Criteria

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Inclusion Criteria

* Heart failure patients at the outpatient heart failure clinic at Levanger Hospital, which have consented to participate in the study.

Exclusion Criteria

* As for inclusion, when the patient is not able to consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Havard Dalen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helse Nord-Trøndelag HF

Locations

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Levanger Hospital

Levanger, , Norway

Site Status

Countries

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Norway

Other Identifiers

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LH_2016-1

Identifier Type: -

Identifier Source: org_study_id