Improvement of Treatment Satisfaction
Conditions
Keywords
ICD, Home-Monitoring, Quality of life
Brief summary
Remote monitoring of implantable cardioverter defibrillators (ICD) is a promising new development in ICD therapy and has been shown to be technically feasible and safe.While data on safety and feasibility of remote monitoring are in favour of this technology, patients´ treatment satisfaction has not been sufficiently investigated. To date, there is only one small, non-randomised study investigating patients´ treatment satisfaction in highly selected and highly motivated patients at the time of implantation and 12 months thereafter7. Therefore, the aim of the San Remo Trial is to investigate factors that are associated with patients´ willingness to accept the new method of follow-up on a broad basis of ICD recipients and to determine their treatment satisfaction with ICD therapy in a randomised, prospective trial.
Interventions
DEVICEHome-Monitoring
Home-Monitoring
DEVICEFollow-up by Home-Monitoring
Follow-up by Home-Monitoring
Sponsors
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* ICD indication according to current national or international guidelines * Patient available for follow-up during study period
Exclusion criteria
* Clinically unstable medical conditions that require regular outpatient clinic follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment satisfaction with ICD therapy and follow-up | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of healthcare consultations | 12 months |
Countries
Germany
Outcome results
None listed