Importance of Patient´s Satisfaction With Telemedicine Based on Monitoring Systems
VALIOSA
1 other identifier
observational
187
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2014
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 17, 2015
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedJuly 3, 2025
November 1, 2017
3.4 years
March 17, 2015
June 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Satisfaction with telemedicine measured by the questionnaire in evaluation
12 months
Secondary Outcomes (2)
Satisfaction with medical treatment measured by visual analog scale
12 months
Quality of Life measured by SF-36
12 months
Study Arms (2)
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
users of CareLink
patients with an implanted cardiac device who have used CareLink for more than one year
Interventions
Eligibility Criteria
Patients with an implantable cardiac device and using CareLink® program for the remote monitoring of the device.
You may qualify if:
- Patients- naïve in CareLink®:
- First implant patients, who initiate in CareLink®
- Replacements patients who initiate in CareLink.
- Long term users in CareLink®: patients in CareLink for more than a year.
- Both male and female
- More than 18 years old.
- Be at the disposal of using CareLink monitoring system.
- Complete informed consent and accept the conditions of CareLink system.
You may not qualify if:
- Less than 18 years old
- Suffer from any menthal pathology who prevents the patient to collaborate in the study.
- Be unable to understand or answer questionnaires in Spanish.
- Deny to continue in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hospital Universitario de Araba
Vitoria-Gasteiz, Basque Country, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2015
First Posted
March 30, 2015
Study Start
May 1, 2014
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
July 3, 2025
Record last verified: 2017-11