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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02888028

Enrollment

182

Registered

2016-09-02

Start date

2011-05-31

Completion date

2014-06-30

Last updated

2018-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression

Keywords

Remote ICD follow-up, HRQoL, Health related Quality of Life, Depression, anxiety, device acceptance, telemedicine, telemonitoring

Brief summary

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

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.

Interventions

PROCEDUREICD remote monitoring

ICD remote monitoring additionally to regular in-office visits

OTHERControl group

Regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Influence of ICD remote monitoring on Quality of Life, measured by the EQ5D questionnaire	12 months

Secondary

Measure	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026