Nordland Hospital
Bodø, Nordland, N - 8092, Norway
NCT Number: NCT02237404
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bodø, Nordland, N - 8092, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Telemedicine System is used in remote monitoring group
Other names: Patients are monitorized from hospital
Time frame: 6 months
Selected variables from the medical history records:
Time frame: 6 months
EuroQol-5Dimensions (EQ-5D)
Time frame: 6 months
Minnesota Living With Heart Failure Questionnaire (MLHF)
Time frame: 6 months
Time frame: 6 months
Number of unscheduled visits and hospitalizations
Time frame: 6 months
Direct costs taken into account:
Time frame: 6 months
Maintenance of the medical consultation (hospital):
Time frame: 6 months
Costs related to the care and displacements of patients to hospital:
University of Tromso
Other
Sustainability of Cardiology Services: Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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