NCT02888028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2014

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

2.9 years

First QC Date

July 3, 2014

Last Update Submit

June 20, 2018

Conditions

AnxietyDepression

Keywords

Remote ICD follow-upHRQoLHealth related Quality of LifeDepressionanxietydevice acceptancetelemedicinetelemonitoring

Outcome Measures

Primary Outcomes (1)

  • Influence of ICD remote monitoring on Quality of Life, measured by the EQ5D questionnaire

    12 months

Secondary Outcomes (2)

  • 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

Study Arms (2)

ICD remote monitoring

ACTIVE COMPARATOR

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

Control group

OTHER

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

Interventions

ICD remote monitoringPROCEDURE

ICD remote monitoring additionally to regular in-office visits

ICD remote monitoring
Control groupOTHER

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \<18 years
  • Subjects not able to give written informed consent
  • Subjects without sufficient German language skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bielefeld University, School of public health

Bielefeld, 33615, Germany

Location

Munich University Clinic, Campus Grosshadern

Munich, 81377, Germany

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Johannes Siebermair, MD

    Munich University Clinic, Campus Grosshadern, Munich, Germany

    PRINCIPAL INVESTIGATOR

  • Florian Leppert, MSc

    Bielefeld University, School of public health Bielefeld, Germany

    PRINCIPAL INVESTIGATOR

  • Stefan Kääb, MD

    Munich University Clinic, Campus Grosshadern, Munich, Germany

    PRINCIPAL INVESTIGATOR

  • Wolfgang Greiner, MD

    Bielefeld University, School of public health, Bielefeld, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Johannes Siebermair, MD

Study Record Dates

First Submitted

July 3, 2014

First Posted

September 2, 2016

Study Start

May 1, 2011

Primary Completion

April 1, 2014

Study Completion

June 1, 2014

Last Updated

June 21, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)