Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers
NCT ID: NCT02237404
Last Updated: 2017-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2014-08-31
2017-11-30
Brief Summary
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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.
Detailed Description
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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:
1. Remote monitoring group: Biotronik Estella SR-T and DR-T \& Biotronik Evia SR-T and DR-T.
2. Hospital monitoring group: St Jude Medical Endurity SR and DR \& Sorin Reply 200 SR and DR.
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Hospital monitoring of pacemakers
Patients have to go to the hospital to be monitorized
No interventions assigned to this group
Remote monitoring of pacemakers
Telemedicine System:
Patients have not to go to the hospital to be monitorized
Telemedicine System
Telemedicine System is used in remote monitoring group
Interventions
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Telemedicine System
Telemedicine System is used in remote monitoring group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a pacemaker implanted
* Understand and be able to properly perform self-monitoring at home
Exclusion Criteria
* Refuse to participate in the study
* Have implanted a different cardiac device to the pacemaker
18 Years
ALL
No
Sponsors
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University of Tromso
OTHER
Responsible Party
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Antonio Lopez Villegas
PhD student
Locations
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Nordland Hospital
Bodø, Nordland, Norway
Countries
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References
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Lopez-Villegas A, Catalan-Matamoros D, Peiro S, Lappegard KT, Lopez-Liria R. Cost-utility analysis of telemonitoring versus conventional hospital-based follow-up of patients with pacemakers. The NORDLAND randomized clinical trial. PLoS One. 2020 Jan 29;15(1):e0226188. doi: 10.1371/journal.pone.0226188. eCollection 2020.
Lopez-Liria R, Lopez-Villegas A, Enebakk T, Thunhaug H, Lappegard KT, Catalan-Matamoros D. Telemonitoring and Quality of Life in Patients after 12 Months Following a Pacemaker Implant: the Nordland Study, a Randomised Trial. Int J Environ Res Public Health. 2019 Jun 5;16(11):2001. doi: 10.3390/ijerph16112001.
Lopez-Villegas A, Catalan-Matamoros D, Lopez-Liria R, Enebakk T, Thunhaug H, Lappegard KT. Health-related quality of life on tele-monitoring for users with pacemakers 6 months after implant: the NORDLAND study, a randomized trial. BMC Geriatr. 2018 Sep 21;18(1):223. doi: 10.1186/s12877-018-0911-3.
Other Identifiers
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008WABELCMW2014A
Identifier Type: -
Identifier Source: org_study_id