Clinical trial NCT00325221: Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)
Official title: QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Quality of Life
Keywords: implantable cardioverter-defibrillator
telemedicine
Home Monitoring
psychosomatic
ventricular tachyarrhythmia
quality of life
Electric Countershock
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2006-05-12
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS) anxiety score
timeFrame: 9 and 18 months
Secondary outcomes:
measure: HADS depression score
timeFrame: 9 and 18 months
measure: Quality of life (SF-12)
timeFrame: 9 and 18 months
measure: Prevalence of Type D personality among ICD patients
timeFrame: 9 and 18 months
measure: Frequency of contacts between patient and physician
timeFrame: 9 and 18 months
measure: Patient's perception of ICD therapy
timeFrame: 9 and 18 months
measure: Patient mobility
timeFrame: 9 and 18 months
Other outcomes:
Locations:
city: Ried
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Ried
city: Wien
country: Austria
facility: Hanusch-Krankenhaus
city: Coswig
country: Germany
facility: Herzzentrum Coswig
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Nuernberg
country: Germany
facility: Krankenhaus Martha-Maria Nürnberg
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Zürich
country: Switzerland
facility: Universitätsklinikum
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Matthias Wilhelm, Dr. Med.
role: PRINCIPAL_INVESTIGATOR
References: