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

NCT ID: NCT00325221

Last Updated: 2013-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2012-10-31

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.

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.

Conditions

Arrhythmia; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home Monitoring On

Home Monitoring activated after implantation (Intervention HM On)

Group Type: EXPERIMENTAL

HM on

Intervention Type: DEVICE

Home Monitoring activated after implantation

Home Monitoring Off

Home Monitoring activated 9 months after implantation (Intervention HM Off)

Group Type: EXPERIMENTAL

HM Off

Intervention Type: DEVICE

Home Monitoring activated 9 months after implantation

Interventions

HM on

Home Monitoring activated after implantation

Intervention Type: DEVICE

HM Off

Home Monitoring activated 9 months after implantation

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias Wilhelm, Dr. Med.

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

Krankenhaus der Barmherzigen Schwestern Ried

Ried, , Austria

Hanusch-Krankenhaus

Vienna, , Austria

Herzzentrum Coswig

Coswig, , Germany

Universitätsklinikum Erlangen

Erlangen, , Germany

Krankenhaus Martha-Maria Nürnberg

Nuremberg, , Germany

Universitätsklinikum Würzburg

Würzburg, , Germany

Universitätsklinikum

Zurich, , Switzerland

Countries

Austria; Germany; Switzerland

Other Identifiers

HS033

Identifier Type: -

Identifier Source: org_study_id