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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00325221
First received: May 11, 2006
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Arrhythmia
Quality of Life
Device: HM on
Device: HM Off

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Hospital Anxiety and Depression Scale (HADS) anxiety score [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HADS depression score [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
  • Quality of life (SF-12) [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
  • Prevalence of Type D personality among ICD patients [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
  • Frequency of contacts between patient and physician [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
  • Patient's perception of ICD therapy [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
  • Patient mobility [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: August 2006
Study Completion Date: October 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home Monitoring On
Home Monitoring activated after implantation (Intervention HM On)
Device: HM on
Home Monitoring activated after implantation
Experimental: Home Monitoring Off
Home Monitoring activated 9 months after implantation (Intervention HM Off)
Device: HM Off
Home Monitoring activated 9 months after implantation

Detailed Description:

Our study investigates the influence of automatic remote patient monitoring on quality of life (QOL), anxiety and depression in patients with implantable cardioverter-defibrillators (ICDs), and frequency of (un-)scheduled patient-physician contacts. The study also evaluates monitoring-induced changes in patient mobility and in patients' perceptions of ICD therapy.

The patients will receive BIOTRONIK Lexos-T or Lumos-T ICD models, with the integrated Home Monitoring capability. The latter allows wireless, everyday transfer of the essential status and therapy data from the ICD memory to a website accessible by the attending physicians. The website is managed by BIOTRONIK Home Monitoring Service Center.

Patients will be randomised into:

  • Group 1: Home Monitoring is established from the outset.
  • Group 2: Home Monitoring is introduced 9 months after ICD implantation.

Follow-up for both groups is 18 months.

Study Hypothesis: Home Monitoring improves the Hospital Anxiety Score in ICD patients.

Preoperatively, HADS (Hospital Anxiety and Depression Scale), Questionnaire on Type D personality (DS 14), and SF-12 Questionnaire will be applied. At follow-up visits every 3 months, HADS, SF-12 Questionnaire, Shock Sensation Questionnaire, number of shocks since preceding follow-up visit, and medications (cardiovascular drugs, psychopharmacological drugs and barbiturates) will be evaluated. Home Monitoring ICD Impact Questionnaire will be collected at the final 18-month follow-up.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325221

Locations
Austria
Krankenhaus der Barmherzigen Schwestern Ried
Ried, Austria, 4910
Hanusch-Krankenhaus
Wien, Austria, 1140
Germany
Herzzentrum Coswig
Coswig, Germany, 06869
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Krankenhaus Martha-Maria Nürnberg
Nuernberg, Germany, 90491
Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Switzerland
Universitätsklinikum
Zürich, Switzerland
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Principal Investigator: Matthias Wilhelm, Dr. Med. University Hospital Inselspital, Berne
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00325221     History of Changes
Other Study ID Numbers: HS033
Study First Received: May 11, 2006
Last Updated: January 30, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:
implantable cardioverter-defibrillator
telemedicine
Home Monitoring
psychosomatic
ventricular tachyarrhythmia
quality of life
Electric Countershock

ClinicalTrials.gov processed this record on October 20, 2014