An interventional study of Telemedicine System in Cardiovascular Disease, sponsored by University of Tromso. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-07.
Sponsored by University of Tromso · Not applicable, Interventional, and Health services research
The purpose of this research is to estimate the outcomes in health and cost of the follow-up of patients with pacemakers.
The initial hypothesize of this study is that remote monitoring of pacemaker will show a best relation of outcomes in costs and effectiveness than the conventional follow-up in hospital.
Cardiovascular Diseases are a major cause of global morbidity and mortality, being responsible according to the World Health Organization of the 30% of overall mortality.
Since 2001 that the first pacemaker of remote monitoring was implanted in Europe, more than 300,000 pacemaker have been implanted around the world. Despite this sharp expansion, the scientific evidence on economic evaluations of pacemaker with remote monitoring is very limited, and in our knowledge, studies including informal costs have not been conducted.
In the field of cardiology, telemedicine allows consultations with patients through monitoring systems and remote communication analyzing the ongoing heart rates of people with pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy and subcutaneous Holter. The use of remote monitoring may save time and efforts to both healthcare professionals and patients, including their informal caregivers, reducing the number of follow up visits to the hospital and reducing the associated costs with patient follow-up, which will help to improve sustainability of healthcare services.
During the 06 months of study, the patients with implant of pacemakers of both groups will be assessed of the same parameters, in 3 different moments (pre-implant and months 1, and 6 post-implantation).
Pacemakers that are going to be used in the project:
The study will estimate: 1) The Clinical features of the patients. 2) The effectiveness through of administration of Health-Related Quality of Life questionnaires and 3) Finally, hospital and informal costs of patients with pacemakers will be estimated by the researches.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Tromso is the lead sponsor of 61 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients have to go to the hospital to be monitorized
Telemedicine System: Patients have not to go to the hospital to be monitorized
Device: Telemedicine System
Telemedicine System is used in remote monitoring group
Also known as: Patients are monitorized from hospital
Clinical features
Selected variables from the medical history records: * Gender * Age * Indication for the implantation of the pacemaker. * Comorbidities * Pharmacological treatment * Vital signs * Pacemaker parameters
Time frame: 6 months
Health-Related Quality of Life
EuroQol-5Dimensions (EQ-5D)
Time frame: 6 months
Health-Related Quality of Life
Minnesota Living With Heart Failure Questionnaire (MLHF)
Time frame: 6 months
Safety
* Number of patients with Adverse Events * Type of Adverse Events diagnosed
Time frame: 6 months
Consultations and Hospitalizations unscheduled
Number of unscheduled visits and hospitalizations
Time frame: 6 months
Direct costs
Direct costs taken into account: * Pacemakers' costs (device implanted) * Hospitalizations' costs * Consultations' costs (hospital) * Prescribed medical transport's cost * Health personnel costs * Pharmaceutical costs
Time frame: 6 months
Indirect cost
Maintenance of the medical consultation (hospital): * Electricity * Cleaning * Furniture * Health fungible * Equipment investment
Time frame: 6 months
Informal costs
Costs related to the care and displacements of patients to hospital: * Displacement costs to hospital * Accommodation costs * Cost of meals * Costs for caregivers
Time frame: 6 months
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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University of Tromso