Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers

November 6, 2017 updated by: Antonio Lopez Villegas, University of Tromso

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Nordland
      • Bodo, Nordland, Norway, N - 8092
        • Nordland Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Hospital monitoring of pacemakers
Patients have to go to the hospital to be monitorized
Experimental: Remote monitoring of pacemakers

Telemedicine System:

Patients have not to go to the hospital to be monitorized
Device: Telemedicine System
Telemedicine System is used in remote monitoring group
Other Names:
  • Patients are monitorized from hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical features
Time Frame: 6 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life
Time Frame: 6 months
EuroQol-5Dimensions (EQ-5D)
6 months
Health-Related Quality of Life
Time Frame: 6 months
Minnesota Living With Heart Failure Questionnaire (MLHF)
6 months
Safety
Time Frame: 6 months
  • Number of patients with Adverse Events
  • Type of Adverse Events diagnosed
6 months
Consultations and Hospitalizations unscheduled
Time Frame: 6 months
Number of unscheduled visits and hospitalizations
6 months
Direct costs
Time Frame: 6 months

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
Indirect cost
Time Frame: 6 months

Maintenance of the medical consultation (hospital):

  • Electricity
  • Cleaning
  • Furniture
  • Health fungible
  • Equipment investment
6 months
Informal costs
Time Frame: 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tromso

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimate)

September 11, 2014

Study Record Updates

Last Update Posted (Actual)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 008WABELCMW2014A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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