Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices

Study Overview
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Brief Summary
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A relatively new and promising development in the area of cardiovascular implantable electronic device therapy is remote patient monitoring (RPM). RPM systems can interrogate the device automatically and send the data from the patients' home to the physician, thereby reducing in-clinic follow-ups. The purpose of this study is to evaluate the effect of RPM + in-clinic follow-up versus in-clinic follow-up only on patient-reported health status and device-acceptance after implantation with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization defibrillator (CRT-D). Secondary objectives are (1) to identify subgroups of patients who prefer RPM over in-clinic visits or vice versa due to specific clinical and psychological factors and (2) To investigate the cost-effectiveness of RPM + in-clinic follow-up compared to in-clinic follow-up only.

Official Title
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Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Device: Remote patient monitoring
* Other: In-Clinic check-ups


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first time ICD/CRT-D implanted at one of the participating centers left ventricular ejection fraction <35% NYHA functional class II or III symptoms ICD/CRT-D device compatible with the LATITUDE(r) RPM system from Boston Scientific Exclusion Criteria: On the waiting list for heart transplantation History of psychiatric illness others than affective/anxiety disorders Cognitive impairments Insufficient knowledge of the language to fill in the questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote patient management<br>Remote patient management system + yearly in-clinic follow-up | Device: Remote patient monitoring<br>* Remote monitoring of ICD and heart failure data<br>* Other names: Boston Scientific LATITUDE system;Other: In-Clinic check-ups<br>* Calender-based In-Clinic ICD check-up<br>|
| Other: In-Clinic follow-up<br>In-clinic follow-up according to standard practice (every 3-6 months) | Other: In-Clinic check-ups<br>* Calender-based In-Clinic ICD check-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported health status | 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ) | 24 months | 
| Patient-reported device acceptance | 12-item Florida Patient Acceptance Scale (FPAS) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported satisfaction with care | Visual Analogue Scale ranging from 0-100 (with higher score representing more satisfaction with care) 26-item self-made questionnaire to assess satisfaction with RPM | 24 months | 
| Cost-effectiveness | Data regarding health care utilization is gathered from hospitals and patients. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implantable defibrillators, remote patient monitoring, patient-reported outcomes, cost-effectiveness