MedTrace Logo

Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)

NCT00325221 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2013-01-31

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

HM on

Home Monitoring activated after implantation

DEVICE

HM Off

Home Monitoring activated 9 months after implantation

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Matthias Wilhelm, Dr. Med. · Insel Gruppe AG, University Hospital Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2012-01-31
Completion
2012-10-31

Countries

  • Austria
  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00325221 on ClinicalTrials.gov