Remote Monitoring of Patients With CHF in Central Greece

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Renewing Health RCT for the Evaluation of Remote Monitoring of Patients With Congestive Heart Failure (CHF) in Central Greece

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Procedure: Home telemonitoring of patients with CHF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>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. | |
| Experimental: Home telemonitoring of patients with CHF<br> | Procedure: Home telemonitoring of patients with CHF<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined end point of all cause mortality |  | 12 months minimum | 
| Number of hospitalisations for heart failure |  | 12 months minimum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular and all-cause mortality |  | 12 months minimum | 
| Health related quality of life as measured by the SF-36 v2 |  | 12 months minimum- at the entry point of the intervention and the end | 
| Patient's specific activity using Specific activity questionnaire (SAQ) and the Veterans specific activity questionnaire (VSAQ) |  | 12 months minimum- at the entry point of the intervention and the end. | 
| Disease Specific Quality of Life using the Minnesota Living with Heart Failure questionnaire (MLHF) |  | 12 months minimum- at the entry point of the intervention and the end. | 
| Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis) |  | 12 months minimum | 
| Patients' Acceptance-Satisfaction measured by the WSD Questionnaire |  | at 2nd and at 12th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congestive Heart Failure, Telemedicine