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

Quality of Life Clinical Trial

Official title:

QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325221
• Other study ID #: HS033
• Status: Completed
• Phase: N/A
• First received: May 11, 2006
• Last updated: January 30, 2013
• Start date: August 2006
• Est. completion date: October 2012

Study information

• Verified date: January 2013
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: October 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmia
• Quality of Life

Intervention

Device:
• HM on
Home Monitoring activated after implantation
• HM Off
Home Monitoring activated 9 months after implantation

Locations

Country	Name	City	State
Austria	Krankenhaus der Barmherzigen Schwestern Ried	Ried
Austria	Hanusch-Krankenhaus	Wien
Germany	Herzzentrum Coswig	Coswig
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Krankenhaus Martha-Maria Nürnberg	Nuernberg
Germany	Universitätsklinikum Würzburg	Würzburg
Switzerland	Universitätsklinikum	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression Scale (HADS) anxiety score		9 and 18 months	No
Secondary	HADS depression score		9 and 18 months	No
Secondary	Quality of life (SF-12)		9 and 18 months	No
Secondary	Prevalence of Type D personality among ICD patients		9 and 18 months	No
Secondary	Frequency of contacts between patient and physician		9 and 18 months	No
Secondary	Patient's perception of ICD therapy		9 and 18 months	No
Secondary	Patient mobility		9 and 18 months	No