Clinical trial NCT02237404: Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers
Official title: Sustainability of Cardiology Services: Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Follow-Up studies
Biological Pacemakers
Telemedicine
Efficiency
Lead sponsor: University of Tromso
Sponsor class: OTHER
First posted: 2014-09-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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:

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.

Eligibility criteria: Inclusion Criteria:

* Be 18 years of age
* Have a pacemaker implanted
* Understand and be able to properly perform self-monitoring at home

Exclusion Criteria:

* Be participating in another study
* Refuse to participate in the study
* Have implanted a different cardiac device to the pacemaker

Primary outcomes:
measure: Clinical features
timeFrame: 6 months
Secondary outcomes:
measure: Health-Related Quality of Life
timeFrame: 6 months
measure: Health-Related Quality of Life
timeFrame: 6 months
measure: Safety
timeFrame: 6 months
measure: Consultations and Hospitalizations unscheduled
timeFrame: 6 months
measure: Direct costs
timeFrame: 6 months
measure: Indirect cost
timeFrame: 6 months
measure: Informal costs
timeFrame: 6 months
Other outcomes:
Locations:
city: Bodo
country: Norway
facility: Nordland Hospital
state: Nordland
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.