Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)
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|ClinicalTrials.gov Identifier: NCT00325221|
Recruitment Status : Completed
First Posted : May 12, 2006
Last Update Posted : January 31, 2013
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 or disease||Intervention/treatment||Phase|
|Arrhythmia Quality of Life||Device: HM on Device: HM Off||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||148 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||October 2012|
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
- Hospital Anxiety and Depression Scale (HADS) anxiety score [ Time Frame: 9 and 18 months ]
- HADS depression score [ Time Frame: 9 and 18 months ]
- Quality of life (SF-12) [ Time Frame: 9 and 18 months ]
- Prevalence of Type D personality among ICD patients [ Time Frame: 9 and 18 months ]
- Frequency of contacts between patient and physician [ Time Frame: 9 and 18 months ]
- Patient's perception of ICD therapy [ Time Frame: 9 and 18 months ]
- Patient mobility [ Time Frame: 9 and 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325221
|Krankenhaus der Barmherzigen Schwestern Ried|
|Ried, Austria, 4910|
|Wien, Austria, 1140|
|Coswig, Germany, 06869|
|Erlangen, Germany, 91054|
|Krankenhaus Martha-Maria Nürnberg|
|Nuernberg, Germany, 90491|
|Würzburg, Germany, 97080|
|Principal Investigator:||Matthias Wilhelm, Dr. Med.||University Hospital Inselspital, Berne|