NCT02237404

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

August 25, 2014

Last Update Submit

November 6, 2017

Conditions

Cardiovascular Disease

Keywords

Follow-Up studiesBiological PacemakersTelemedicineEfficiency

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Health-Related Quality of Life

    6 months

  • Health-Related Quality of Life

    6 months

  • Safety

    6 months

  • Consultations and Hospitalizations unscheduled

    6 months

  • Direct costs

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Hospital monitoring of pacemakers

NO INTERVENTION

Patients have to go to the hospital to be monitorized

Remote monitoring of pacemakers

EXPERIMENTAL

Telemedicine System: Patients have not to go to the hospital to be monitorized

Device: Telemedicine System

Interventions

Telemedicine SystemDEVICE

Telemedicine System is used in remote monitoring group

Also known as: Patients are monitorized from hospital
Remote monitoring of pacemakers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordland Hospital

Bodø, Nordland, N - 8092, Norway

Location

Related Publications (3)

  • 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.

    PMID: 31995558DERIVED

  • 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.

    PMID: 31195650DERIVED

  • 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.

    PMID: 30241511DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

August 25, 2014

First Posted

September 11, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

November 1, 2017

Last Updated

November 7, 2017

Record last verified: 2017-11

Locations

NO(1)