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

Arrythmia Clinical Trial

— VALIOSA  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401659
• Other study ID #: T431 v 2.0
• Status: Completed
• Phase: N/A
• First received: March 17, 2015
• Last updated: November 20, 2017
• Start date: May 2014
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrythmia

Intervention

Device:
• CareLinK

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction with telemedicine measured by the questionnaire in evaluation		12 months
Secondary	Satisfaction with medical treatment measured by visual analog scale		12 months
Secondary	Quality of Life measured by SF-36		12 months