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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00325221
Recruitment Status : Completed
First Posted : May 12, 2006
Last Update Posted : January 31, 2013
Information provided by (Responsible Party):
Biotronik SE & Co. KG

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.

Condition or disease Intervention/treatment Phase
Arrhythmia Quality of Life Device: HM on Device: HM Off Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring
Study Start Date : August 2006
Actual Primary Completion Date : January 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Hospital Anxiety and Depression Scale (HADS) anxiety score [ Time Frame: 9 and 18 months ]

Secondary Outcome Measures :
  1. HADS depression score [ Time Frame: 9 and 18 months ]
  2. Quality of life (SF-12) [ Time Frame: 9 and 18 months ]
  3. Prevalence of Type D personality among ICD patients [ Time Frame: 9 and 18 months ]
  4. Frequency of contacts between patient and physician [ Time Frame: 9 and 18 months ]
  5. Patient's perception of ICD therapy [ Time Frame: 9 and 18 months ]
  6. Patient mobility [ Time Frame: 9 and 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00325221

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

Responsible Party: Biotronik SE & Co. KG Identifier: NCT00325221     History of Changes
Other Study ID Numbers: HS033
First Posted: May 12, 2006    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013

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