NCT02234245

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
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

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

October 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

August 28, 2014

Last Update Submit

May 9, 2023

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

    12 months

Secondary Outcomes (7)

  • Health-Related Quality of Life

    5 years

  • Functional capacity

    5 years

  • Direct costs

    5 years

  • Indirect cost

    5 years

  • Informal costs

    5 years

  • +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)

Hospital de Poniente

El Ejido, Almeria, 04700, Spain

Location

Related Publications (4)

  • Catalan-Matamoros D, Lopez-Villegas A, Leal Costa C, Bautista-Mesa R, Robles-Musso E, Rocamora Perez P, Lopez-Liria R. A non-randomized clinical trial to examine patients' experiences and communication during telemonitoring of pacemakers after five years follow-up. PLoS One. 2021 Dec 23;16(12):e0261158. doi: 10.1371/journal.pone.0261158. eCollection 2021.

    PMID: 34941904DERIVED

  • Bautista-Mesa RJ, Lopez-Villegas A, Peiro S, Catalan-Matamoros D, Robles-Musso E, Lopez-Liria R, Leal-Costa C. Long-term cost-utility analysis of remote monitoring of older patients with pacemakers: the PONIENTE study. BMC Geriatr. 2020 Nov 16;20(1):474. doi: 10.1186/s12877-020-01883-3.

    PMID: 33198629DERIVED

  • Lopez-Villegas A, Catalan-Matamoros D, Robles-Musso E, Peiro S. Workload, time and costs of the informal cares in patients with tele-monitoring of pacemakers: the PONIENTE study. Clin Res Cardiol. 2016 Apr;105(4):307-13. doi: 10.1007/s00392-015-0921-5. Epub 2015 Sep 30.

    PMID: 26423396DERIVED

  • Lopez-Villegas A, Catalan-Matamoros D, Robles-Musso E, Peiro S. [Comparative Effectiveness of Remote Monitoring of People with Cardiac Pacemaker versus Conventional: quality of Life at the 6 Months]. Rev Esp Salud Publica. 2015 Apr;89(2):149-58. doi: 10.4321/S1135-57272015000200004. Spanish.

    PMID: 26121625DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON 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 28, 2014

First Posted

September 9, 2014

Study Start

October 1, 2012

Primary Completion

November 1, 2013

Study Completion

October 1, 2018

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

ES(1)