ArrhythmiaNCT00325221
Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)
A study testing HM on and HM Off in people with Arrhythmia and Quality of Life, run by Biotronik SE & Co. KG at 7 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia, Quality of Life
- What is being tested?
- HM on and HM Off
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Aug 2006to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for ICD implantation either as primary or secondary prevention
- Patient informed consent
Who cannot join
- 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
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Germany4 sites
Herzzentrum Coswig
Coswig, 06869
Universitätsklinikum Erlangen
Erlangen, 91054
Krankenhaus Martha-Maria Nürnberg
Nuremberg, 90491
Universitätsklinikum Würzburg
Würzburg, 97080
Austria2 sites
Krankenhaus der Barmherzigen Schwestern Ried
Ried, 4910
Hanusch-Krankenhaus
Vienna, 1140
About this study
Official title: QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring
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.
Read the 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.
- Conditions
- Arrhythmia, Quality of Life
- Being tested
- HM on, HM Off
- Keywords
- implantable cardioverter-defibrillator, telemedicine, Home Monitoring, psychosomatic, ventricular tachyarrhythmia, quality of life, Electric Countershock
- Medical subject headings
- Arrhythmias, Cardiac, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM onDevice
Home Monitoring activated after implantation
HM OffDevice
Home Monitoring activated 9 months after implantation
| Study group | Role | What they receive |
|---|---|---|
| Home Monitoring On | Experimental | Home Monitoring activated after implantation (Intervention HM On) Receives: Device: HM on |
| Home Monitoring Off | Experimental | Home Monitoring activated 9 months after implantation (Intervention HM Off) Receives: Device: HM Off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS) anxiety score
Measured: 9 and 18 months
Secondary outcomes (6)
HADS depression score
Measured: 9 and 18 months
Quality of life (SF-12)
Measured: 9 and 18 months
Prevalence of Type D personality among ICD patients
Measured: 9 and 18 months
Frequency of contacts between patient and physician
Measured: 9 and 18 months
Patient's perception of ICD therapy
Measured: 9 and 18 months
Patient mobility
Measured: 9 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2006 (estimated)
- Study startAug 2006
- Primary completionJan 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthias Wilhelm, Dr. Med., Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325221
- Sponsor's protocol ID
- HS033
- Status last verified
- Jan 2013
- First submitted
- 11 May 2006
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring
- ClinicalTrials.gov ID
- NCT00325221
- Acronym / sponsor ID
- HS033
- Conditions
- Arrhythmia, Quality of Life
- Keywords
- implantable cardioverter-defibrillator, telemedicine, Home Monitoring, psychosomatic, ventricular tachyarrhythmia, quality of life, Electric Countershock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 12 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Monitoring On | Experimental | Device: HM onHome Monitoring activated after implantation (Intervention HM On) |
| Home Monitoring Off | Experimental | Device: HM OffHome Monitoring activated 9 months after implantation (Intervention HM Off) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for ICD implantation either as primary or secondary prevention
- Patient informed consent
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HM onHome Monitoring activated after implantation | Device | Home Monitoring On |
| HM OffHome Monitoring activated 9 months after implantation | Device | Home Monitoring Off |
Primary outcome
Hospital Anxiety and Depression Scale (HADS) anxiety score
Time frame: 9 and 18 months
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Wilhelm, Dr. Med. principal investigator
Insel Gruppe AG, University Hospital Bern
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HM on and HM Off in people with Arrhythmia and Quality of Life, run by Biotronik SE & Co. KG at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) anxiety score (time frame: 9 and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.