Congestive Heart Failure
Conditions
Keywords
CHF, Telemonitoring
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 study is designed to evaluate the impact of telemonitoring on the management of CHF compared with outpatient usual care. From a clinical point of view, the trial will allow to investigate how telemonitoring contributes to reduct the combined end point of all cause mortality and re-hospitalizations, as well as the other kinds of access to hospital facilities (bed-days, specialistic and ER visits). The trial will examine whether the CHF patients improve their health-related quality of life and reduct the anxiety about health conditions, thanks to the telemonitoring. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professional perception towards the service.
Interventions
PROCEDURETelemonitoring for patients with Congestive Heart Failure
Patients are equipped with a telemonitoring kit composed by a portable wrist-clinic device and digital weight scale for clinical parameters measuring and a gateway device for data transmission. The patient can monitor a complete set of clinical parameters, such as pulse-oxymetry, heart rate, blood pressure, ECG and body weight, with a frequency set by the clinician in the personalised treatment plan. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alerts the reference clinician in case of worsening of symptoms.
Sponsors
European Commission
Azienda Unità Locale Socio Sanitaria n.9 Treviso
Azienda ULSS 7 Conegliano
Azienda ULSS 16 Padova
Azienda ULSS di Verona e Provincia
Azienda ULSS 12 Veneziana
Azienda Unità Socio Sanitaria di Dolo Mirano
Azienda Ospedaliera di Padova
Azienda Ospedaliera Universitaria Integrata Verona
Regione Veneto
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 EF \< 40% or EF \> 40% plus BNP \> 400 (or plus NT-proBNP\>1500) during hospitalization
Exclusion criteria
* Comorbidities prevalent on CHF with life expectation \< 12 months. * Impossibility or inability to use the equipment and help at home not available. * Myocardial infarction or percutaneous coronary intervention in the last 3 months or scheduled. * Coronary artery bypass, valve substitution or correction in the last 6 months. * 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 and number of hospitalisations for heart failure | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life | 12 months | Health-Related Quality of Life is assessed by the SF-36 questionnaire |
| Number of hospitalisations (including rehospitalisations) for all causes and for heart failure | 12 months | — |
| Total number of days in hospital | 12 months | — |
| Cardiovascular and all-cause mortality | 12 months | — |
| Number of visits at emergency department for heart failure | 12 months | — |
| Anxiety and depression status | 12 months | Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale (HADS) |
| Number of specialist visits | 12 months | — |
Countries
Italy
Outcome results
None listed