Remote Monitoring of Patients With CHF in Central Greece

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Telemedical Interventional Management in Heart Failure II

NCT01878630

Chronic Heart Failure

COMPLETED PHASE3

Heart Failure Events Reduction With Remote Monitoring and eHealth Support Investigator Initiated Trial

NCT03663907

Heart Failure

COMPLETED NA

Tele-HF: Yale Heart Failure Telemonitoring Study

NCT00303212

Congestive Heart Failure

COMPLETED NA

Telemedical Interventional Monitoring in Heart Failure

NCT00543881

Chronic Heart Failure

COMPLETED PHASE3

Telemedicine in Heart Failure; Treatment, Prognosis and Patient Experience

NCT06237998

Heart Failure

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to the evaluate the use of a mobile and PSTN phone-based telehealth platform will be able to produce a reduction in the combined end point of all cause mortality, will have positive or negative impact in their generic and disease specific quality of life , or their specific activity compared with usual care. Following this; it is also hypothesized that this will also lead to a change in overall risk for CHF complications. In addition the patients' satisfaction using the telemedicine service will be studied. A Cost-Effective Analysis and Cost Utility Analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congestive Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual Care

Patients in the control group receive usual care delivered by their primary care physicians and cardiologists. Usual care consists of regular visits to the specialist or primary care clinics every time a medication change is required, or a medical examination is needed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Home telemonitoring of patients with CHF

Group Type EXPERIMENTAL

Home telemonitoring of patients with CHF

Intervention Type PROCEDURE

Patients in the intervention group receive a personal 1-lead or 12-lead ECG recorder, a blood pressure monitor, a digital weight scale and appropriate education regarding the use of these devices. ThA trained nurse visits the patients weekly during the first month, and monthly thereafter, to confirm the appropriate use of the devices and services, to monitor symptoms, adherence to pharmacological and non-pharmacological treatment, and to complete the case record forms when necessary.

If there is deterioration in the monitored vital signs, or if symptoms are reported, the allocated cardiologist is informed via the telehealth platform and has to decide whether the patient has to visit the hospital as in- or outpatient and whether the therapy has to be modified.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Home telemonitoring of patients with CHF

Patients in the intervention group receive a personal 1-lead or 12-lead ECG recorder, a blood pressure monitor, a digital weight scale and appropriate education regarding the use of these devices. ThA trained nurse visits the patients weekly during the first month, and monthly thereafter, to confirm the appropriate use of the devices and services, to monitor symptoms, adherence to pharmacological and non-pharmacological treatment, and to complete the case record forms when necessary.

If there is deterioration in the monitored vital signs, or if symptoms are reported, the allocated cardiologist is informed via the telehealth platform and has to decide whether the patient has to visit the hospital as in- or outpatient and whether the therapy has to be modified.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 65 years.
* Discharge from hospital after acute heart failure in the previous 3 months and FE \< 40% or FE \> 40% plus BNP \> 400 (or plus NT-proBNP\>1500) during hospitalization

Exclusion Criteria

* Comorbidities prevalent on CHF with life expectation \< 12 months.
* Inability to use the equipment and help at home not available.
* Myocardial infarction or percutaneous coronary intervention in the last 3 months.
* Coronary artery bypass, valve substitution or correction in the last 6 months or scheduled.
* Being on waiting list for heart transplantation.
* Being enrolled in other trial.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No