NCT00325221

Brief Summary

Quality of life (QOL) and psychological well-being of patients with implantable cardioverter-defibrillators (ICDs) are significantly influenced by the experience of shock therapies. A close therapeutic relationship between patients and physicians, resulting in short reaction times to ICD-treated arrhythmic events and, in an optimised antiarrhythmic therapy, may help the patients to deal with their situations in the best possible way. The researchers investigate the influence of automatic remote patient monitoring on QOL, anxiety, and depression in ICD patients, and kind and frequency of (un-)scheduled patient-physician contacts. They also evaluate monitoring-induced changes in patient mobility and in patients' perceptions of ICD therapy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
3 countries

7 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

First Submitted

Initial submission to the registry

May 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

5.4 years

First QC Date

May 11, 2006

Last Update Submit

January 30, 2013

Conditions

ArrhythmiaQuality of Life

Keywords

implantable cardioverter-defibrillatortelemedicineHome Monitoringpsychosomaticventricular tachyarrhythmiaquality of lifeElectric Countershock

Outcome Measures

Primary Outcomes (1)

  • Hospital Anxiety and Depression Scale (HADS) anxiety score

    9 and 18 months

Secondary Outcomes (6)

  • HADS depression score

    9 and 18 months

  • Quality of life (SF-12)

    9 and 18 months

  • Prevalence of Type D personality among ICD patients

    9 and 18 months

  • Frequency of contacts between patient and physician

    9 and 18 months

  • Patient's perception of ICD therapy

    9 and 18 months

  • +1 more secondary outcomes

Study Arms (2)

Home Monitoring On

EXPERIMENTAL

Home Monitoring activated after implantation (Intervention HM On)

Device: HM on

Home Monitoring Off

EXPERIMENTAL

Home Monitoring activated 9 months after implantation (Intervention HM Off)

Device: HM Off

Interventions

HM onDEVICE

Home Monitoring activated after implantation

Home Monitoring On
HM OffDEVICE

Home Monitoring activated 9 months after implantation

Home Monitoring Off

Eligibility Criteria

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

You may qualify if:

  • Indication for ICD implantation either as primary or secondary prevention
  • Patient informed consent

You may not qualify if:

  • ICD replacement indication
  • Indication for cardiac resynchronisation therapy
  • Inability to fully understand psychosomatic questionnaires, especially cognitive impairment or German language deficits
  • Co-morbidities with a resulting life expectancy of less than one year
  • Psychosomatic disease (requiring psychiatric therapy)
  • Age \<18 years
  • Patients who are already enrolled in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Krankenhaus der Barmherzigen Schwestern Ried

Ried, 4910, Austria

Location

Hanusch-Krankenhaus

Vienna, 1140, Austria

Location

Herzzentrum Coswig

Coswig, 06869, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Krankenhaus Martha-Maria Nürnberg

Nuremberg, 90491, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Universitätsklinikum

Zurich, Switzerland

Location

MeSH Terms

Conditions

Arrhythmias, CardiacTachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardiaCardiac Conduction System Disease

Study Officials

  • Matthias Wilhelm, Dr. Med.

    Insel Gruppe AG, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2006

First Posted

May 12, 2006

Study Start

August 1, 2006

Primary Completion

January 1, 2012

Study Completion

October 1, 2012

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

CH(1)AU(2)DE(4)