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

QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Arrhythmia
• Intervention / Treatment: Device: HM on; Device: HM Off

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
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Ried, Austria, 4910
    • Krankenhaus der Barmherzigen Schwestern Ried
  • Wien, Austria, 1140
    • Hanusch-Krankenhaus
• Germany
  • Coswig, Germany, 06869
    • Herzzentrum Coswig
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen
  • Nuernberg, Germany, 90491
    • Krankenhaus Martha-Maria Nürnberg
  • Würzburg, Germany, 97080
    • Universitatsklinikum Wurzburg
• Switzerland
  • Zürich, Switzerland
    • Universitätsklinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospital Anxiety and Depression Scale (HADS) anxiety score	9 and 18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
HADS depression score	9 and 18 months
Quality of life (SF-12)	9 and 18 months
Prevalence of Type D personality among ICD patients	9 and 18 months
Frequency of contacts between patient and physician	9 and 18 months
Patient's perception of ICD therapy	9 and 18 months
Patient mobility	9 and 18 months

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Matthias Wilhelm, Dr. Med., University Hospital Inselspital, Berne

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: May 11, 2006
• First Submitted That Met QC Criteria: May 11, 2006
• First Posted (Estimate): May 12, 2006

Study Record Updates

• Last Update Posted (Estimate): January 31, 2013
• Last Update Submitted That Met QC Criteria: January 30, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: quality of life; telemedicine; implantable cardioverter-defibrillator; Home Monitoring; psychosomatic; Electric Countershock; ventricular tachyarrhythmia
• Other Study ID Numbers: HS033