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

Not Applicable

Completed

• Conditions: Arrhythmia; Quality of Life
• Interventions: Device: HM on; Device: HM Off

• Registration Number: NCT00325221
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2006-05-11
• Study First Submitted QC: 2006-05-11
• Study First Posted: 2006-05-12
• Study Start: 2006-08
• Primary Completion: 2012-01
• Study Completion: 2012-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-30
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home Monitoring On	HM on	Home Monitoring activated after implantation (Intervention HM On)
Home Monitoring Off	HM Off	Home Monitoring activated 9 months after implantation (Intervention HM Off)

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS) anxiety score	9 and 18 months

Secondary Outcome Measures

Name	Time	Method
Patient's perception of ICD therapy	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
HADS depression score	9 and 18 months
Frequency of contacts between patient and physician	9 and 18 months
Patient mobility	9 and 18 months

Trial Locations

Locations (7)

Krankenhaus der Barmherzigen Schwestern Ried; 🇦🇹 Ried, Austria

Krankenhaus Martha-Maria Nürnberg; 🇩🇪 Nuernberg, Germany

Hanusch-Krankenhaus; 🇦🇹 Wien, Austria

Herzzentrum Coswig; 🇩🇪 Coswig, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Germany

Universitätsklinikum; 🇨🇭 Zürich, Switzerland