Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM) - Full Text View

Sponsor:	Biotronik SE & Co. KG
Information provided by:	Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:	NCT00325221

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	Phase
Arrhythmia Quality of Life	Device: BIOTRONIK Lexos-T implantable cardioverter-defibrillator with home monitoring Device: Lumos-T implantable cardioverter-defibrillator with home monitoring	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Anxiety Arrhythmia Depression Pacemakers and Implantable Defibrillators

U.S. FDA Resources

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

Primary Outcome Measures:

Hospital Anxiety and Depression Scale (HADS) anxiety score

Secondary Outcome Measures:

HADS depression score
Quality of life (SF-12)
Prevalence of Type D personality among ICD patients
Frequency of contacts between patient and physician
Patient's perception of ICD therapy
Patient mobility

Estimated Enrollment:	150
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2010

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

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

Contacts

Contact: Sabine Mitzenheim, BS	+49 9131 8924 7823	sabine.mitzenheim@biotronik.com
Contact: Petra Maier, PhD	+49 9131 8924 7820	petra.maier@biotronik.com

Locations

Austria
Krankenhaus der Barmherzigen Schwestern Ried	Recruiting
Ried, Austria, 4910
Principal Investigator: Christopher Nimeth, OA Dr.
Hanusch-Krankenhaus	Recruiting
Wien, Austria, 1140
Principal Investigator: Michael Gruska, OA Dr.
Germany
Universitätsklinikum Erlangen	Recruiting
Erlangen, Germany, 91054
Principal Investigator: Matthias Wilhelm, OA Dr.
Krankenhaus Martha-Maria Nürnberg	Completed
Nuernberg, Germany, 90491
Herzzentrum Coswig	Active, not recruiting
Coswig, Germany, 06869
Universitätsklinikum Würzburg	Recruiting
Würzburg, Germany, 97080
Principal Investigator: Wolfgang Bauer, Prof. Dr.
Switzerland
Universitätsklinikum	Active, not recruiting
Zürich, Switzerland

Sponsors and Collaborators

Biotronik SE & Co. KG

Investigators

Principal Investigator:

Matthias Wilhelm, Dr. Med.

Universitätsklinikum Erlangen, Medizinische Klinik 2 - Kardiologie und Angiologie, Ulmenweg 18, D-91054 Erlangen, Germany

More Information

No publications provided

Study ID Numbers:	HS033
Study First Received:	May 11, 2006
Last Updated:	August 21, 2009
ClinicalTrials.gov Identifier:	NCT00325221 History of Changes
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

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010