Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325221
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2006-05-11
Brief Title:
Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function QUANTUM
Sponsor:
Biotronik SE Co KG
Organization:
Biotronik SE Co KG
Study Overview
Official Title:
QUANTUM - Quality-of-Life Anxiety and Depression in ICD Patients Using Home Monitoring
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None