Skip to main content
OpenTrials
Completed

NCT Number: NCT00325221

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krankenhaus der Barmherzigen Schwestern Ried, Ried, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HM on

Device

Home Monitoring activated after implantation

HM Off

Device

Home Monitoring activated 9 months after implantation

Primary outcomes

  1. Hospital Anxiety and Depression Scale (HADS) anxiety score

    Time frame: 9 and 18 months

Secondary outcomes

  1. HADS depression score

    Time frame: 9 and 18 months

  2. Quality of life (SF-12)

    Time frame: 9 and 18 months

  3. Prevalence of Type D personality among ICD patients

    Time frame: 9 and 18 months

  4. Frequency of contacts between patient and physician

    Time frame: 9 and 18 months

  5. Patient's perception of ICD therapy

    Time frame: 9 and 18 months

  6. Patient mobility

    Time frame: 9 and 18 months

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
May 12, 2006
Registry last updated
Jan 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.