Quality of Life and Device Acceptance in Patients With ICD Undergoing Remote ICD FU

Study Overview
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Brief Summary
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This study investigates whether an additional remote follow-up of patients with implantable cardioverter-defibrillators (ICDs) has beneficial effects on Quality of life (QoL), levels of anxiety and depression and device acceptance. Patients are randomized to either conventional in-office FU only or additional remote surveillance, follow-up duration is 12 months. The influence of other variables (age, sex,..) is evaluated regarding their influence on study endpoints.

Detailed Description
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The rising number of implantable cardiac devices leads to an increasing amount of device-related workload, e.g. regular in-office follow-ups (FU). New means of ICD FU strategies are necessary to handle the increasing burden. ICD remote monitoring promises a time- and cost efficient alternative to conventional in-office FU strategies. Many studies have already shown benefits on FU burden reduction, on saving of costs and time, and recently on total mortality. The impact of remote ICD FU on Quality of life, anxiety and depression levels and device acceptance is still under discussion. The aim of this trial is to investigate the influence of additional remote ICD surveillance on the primary endpoint health related quality of life (HRQoL), further on levels of anxiety and depression and on device acceptance.

Official Title
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Quality of Life and Device Acceptance in Patients With Implantable Cardioverter-defibrillators Undergoing Remote ICD Follow-up

Conditions
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Anxiety, Depression

Intervention / Treatment
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* Procedure: ICD remote monitoring
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients willing to participate Patients with new-implantation of an ICD or device replacement due to battery depletion between May 2011 and April 2013 Sufficient knowledge of the German language Expectancy of life >1 years at good clinical status Written informed consent Exclusion Criteria: Age <18 years Subjects not able to give written informed consent Subjects without sufficient German language skills

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICD remote monitoring<br>Active Comparator: ICD remote monitoring additionally to regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement | Procedure: ICD remote monitoring<br>* ICD remote monitoring additionally to regular in-office visits<br>|
| Other: Control group<br>Regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU | Other: Control group<br>* Regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of ICD remote monitoring on Quality of Life, measured by the EQ5D questionnaire |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of ICD remote monitoring on levels of anxiety and depression, measured by the HADS questionnaire (Hospital Anxiety and Depression scale) |  | 12 months | 
| Influence of ICD remote monitoring on device acceptance, measured by the Florida Patient acceptance scale (FPAS) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote ICD follow-up, HRQoL, Health related Quality of Life, Depression, anxiety, device acceptance, telemedicine, telemonitoring