Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring|
- Hospital Anxiety and Depression Scale (HADS) anxiety score [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
- HADS depression score [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
- Quality of life (SF-12) [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
- Prevalence of Type D personality among ICD patients [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
- Frequency of contacts between patient and physician [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
- Patient's perception of ICD therapy [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
- Patient mobility [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Study Completion Date:||October 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|