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

Completed

• Conditions: Arrythmia
• Interventions: Device: CareLinK

• Registration Number: NCT02401659
• Lead Sponsor: Medtronic Bakken Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-03-17
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-30
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-20
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
users of CareLink	CareLinK	patients with an implanted cardiac device who have used CareLink for more than one year
naïve with CareLink	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

Primary Outcome Measures

Name	Time	Method
Satisfaction with telemedicine measured by the questionnaire in evaluation	12 months

Secondary Outcome Measures

Name	Time	Method
Satisfaction with medical treatment measured by visual analog scale	12 months
Quality of Life measured by SF-36	12 months

Trial Locations

Locations (4)

Hospital Universitario de Araba; 🇪🇸 Vitoria, Basque Country, Spain

Hospital Santa Creu i Sant Pau; 🇪🇸 Barcelona, Catalonia, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain