Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers

Cardiovascular Disease Clinical Trial

Official title:

Sustainability of Cardiology Services: Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237404
• Other study ID #: 008WABELCMW2014A
• Status: Completed
• Phase: N/A
• First received: August 25, 2014
• Last updated: November 6, 2017
• Start date: August 2014
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Device:
• Telemedicine System
Telemedicine System is used in remote monitoring group

Locations

Country	Name	City	State
Norway	Nordland Hospital	Bodo	Nordland

Sponsors (1)

Lead Sponsor	Collaborator
University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	Health-Related Quality of Life	EuroQol-5Dimensions (EQ-5D)	6 months
Secondary	Health-Related Quality of Life	Minnesota Living With Heart Failure Questionnaire (MLHF)	6 months
Secondary	Safety	Number of patients with Adverse Events; Type of Adverse Events diagnosed	6 months
Secondary	Consultations and Hospitalizations unscheduled	Number of unscheduled visits and hospitalizations	6 months
Secondary	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	6 months
Secondary	Indirect cost	Maintenance of the medical consultation (hospital): Electricity; Cleaning; Furniture; Health fungible; Equipment investment	6 months
Secondary	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	6 months