Importance of Patient´s Satisfaction With Telemedicine Based on Monitoring Systems (VALIOSA)

November 20, 2017 updated by: Medtronic Bakken Research Center
Valiosa is a national, multicenter and prospective post market study. The objectives of the study are to generate and validate an instrument to evaluate patient and clinician's satisfaction with remote monitoring and to create awareness of the importance of remote monitoring among patients, physicians and decision makers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

187

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

  • Spain
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario Infanta Leonor
    • Basque Country
      • Vitoria, Basque Country, Spain
        • Hospital Universitario de Araba
    • Catalonia
      • Barcelona, Catalonia, Spain
        • Hospital Santa Creu i Sant Pau

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

Sampling Method

Non-Probability Sample

Study Population

Patients with an implantable cardiac device and using CareLink® program for the remote monitoring of the device.

Description

Inclusion Criteria:

  1. Patients- naïve in CareLink®:

    • First implant patients, who initiate in CareLink®
    • Replacements patients who initiate in CareLink.
  2. Long term users in CareLink®: patients in CareLink for more than a year.
  3. Both male and female
  4. More than 18 years old.
  5. Be at the disposal of using CareLink monitoring system.
  6. Complete informed consent and accept the conditions of CareLink system.

Exclusion Criteria:

  1. Less than 18 years old
  2. Suffer from any menthal pathology who prevents the patient to collaborate in the study.
  3. Be unable to understand or answer questionnaires in Spanish.
  4. Deny to continue in the study.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
naïve with CareLink
patients with a first implant of an implanted cardiac device naïve in CareLink or patients with a refill who have not used CareLink until the implant
Device: CareLinK
users of CareLink
patients with an implanted cardiac device who have used CareLink for more than one year
Device: CareLinK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Satisfaction with telemedicine measured by the questionnaire in evaluation
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Satisfaction with medical treatment measured by visual analog scale
Time Frame: 12 months
12 months
Quality of Life measured by SF-36
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Medtronic Bakken Research Center

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

May 1, 2014

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Actual)

November 22, 2017

Last Update Submitted That Met QC Criteria

November 20, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T431 v 2.0

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.

Clinical Trials on Arrythmia

Clinical Trials on CareLinK

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe