Congestive Heart Failure
Conditions
Keywords
Congestive Heart Failure, Telemedicine
Brief summary
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
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.
Interventions
PROCEDUREHome 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.
Sponsors
Ministry for Health and Social Solidarity, Greece
Municipality of Trikala, Greece
Institute of Biomedical Research & Technology, Larissa, Greece
Institute of Communications and Computer Systems, Athens, Greece
Alexander Technological Educational Institute, Thessaloniki, Greece
University of Macedonia, Thessaloniki, Greece
University of Thessaly
Regional Health Authority of Sterea & Thessaly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined end point of all cause mortality | 12 months minimum |
| Number of hospitalisations for heart failure | 12 months minimum |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
| Cardiovascular and all-cause mortality | 12 months minimum |
| Patients' Acceptance-Satisfaction measured by the WSD Questionnaire | at 2nd and at 12th month |
| Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis) | 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 |
Countries
Greece
Outcome results
None listed