Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function

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	Device: Implantable cardioverter-defibrillator with home monitoring	Phase IV

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

Primary Outcomes: Hospital Anxiety and Depression Scale (HADS) anxiety score
Secondary Outcomes: 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
Expected Total Enrollment:  150

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00325221

Sabine Mitzenheim, BS      +49 9131 8924 7823    sabine.mitzenheim@biotronik.com
Karsten Wallbrueck, BS      +49 9131 8924 7820    karsten.wallbrueck@biotronik.com

Austria
      Krankenhaus der Barmherzigen Schwestern Ried, Ried,  4910,  Austria; Not yet recruiting
      Hanusch-Krankenhaus, Wien,  1140,  Austria; Not yet recruiting
Germany
      Universitätsklinikum Erlangen, Erlangen,  91054,  Germany; Not yet recruiting
      Universitätsklinikum Tübingen, Tuebingen,  72076,  Germany; Not yet recruiting
      Krankenhaus Martha-Maria Nürnberg, Nuernberg,  90491,  Germany; Recruiting
Switzerland
      University Hospital Zürich, Zurich,  8091,  Switzerland; Not yet recruiting

Study chairs or principal investigators

Robert Krähner, Dr. Med.,  Principal Investigator,  Universitätsklinikum Erlangen, Medizinische Klinik 2 – Kardiologie und Angiologie, Ulmenweg 18, D-91054 Erlangen, Germany   

Study ID Numbers:  HS033
Last Updated:  August 29, 2006
Record first received:  May 11, 2006
ClinicalTrials.gov Identifier:  NCT00325221
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

 

Pacemakers and Implantable Defibrillators (National Library of Medicine)

Implantable Cardioverter Defibrillator (ICD)  (Food and Drug Administration)

Implantable Cardioverter-Defibrillator  (American Academy of Family Physicians)

ClinicalTrials.gov: Defibrillators, Implantable  (National Institutes of Health)

FDA Update Statement on Boston Scientific/Guidant Pacemakers and Defibrillators  (Food and Drug Administration)

Implantable Cardioverter-Defibrillators: Controlling a Chaotic Heart  (Mayo Foundation for Medical Education and Research)

Treatments for Arrhythmia  (Heart Rhythm Society)

Common Questions about ICDs  (Heart Rhythm Society)

Cardiac Pacemaker (Implanted)  (Food and Drug Administration)

Pacemakers: Generating Regular Heartbeats  (Mayo Foundation for Medical Education and Research)

Managing Your Pacemaker  (American Heart Association)

American Heart Association  (American Heart Association)

ClinicalTrials.gov: Pacemaker, Artificial  (National Institutes of Health)

Dual-Chamber Pacemakers Worth Extra Cost by Reducing Risk of Hospitalization and Disability  (American Heart Association)

Biventricular Pacing  (Mayo Foundation for Medical Education and Research)