Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Zürich, Schweiz
- Universitätsklinikum
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Coswig, Tyskland, 06869
- Herzzentrum Coswig
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Erlangen, Tyskland, 91054
- Universitätsklinikum Erlangen
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Nuernberg, Tyskland, 90491
- Krankenhaus Martha-Maria Nürnberg
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Würzburg, Tyskland, 97080
- Universitätsklinikum Würzburg
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Ried, Österrike, 4910
- Krankenhaus der Barmherzigen Schwestern Ried
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Wien, Österrike, 1140
- Hanusch-Krankenhaus
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Home Monitoring On
Home Monitoring activated after implantation (Intervention HM On)
|
Home Monitoring activated after implantation
|
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Experimentell: Home Monitoring Off
Home Monitoring activated 9 months after implantation (Intervention HM Off)
|
Home Monitoring activated 9 months after implantation
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Hospital Anxiety and Depression Scale (HADS) anxiety score
Tidsram: 9 and 18 months
|
9 and 18 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
HADS depression score
Tidsram: 9 and 18 months
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9 and 18 months
|
|
Quality of life (SF-12)
Tidsram: 9 and 18 months
|
9 and 18 months
|
|
Prevalence of Type D personality among ICD patients
Tidsram: 9 and 18 months
|
9 and 18 months
|
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Frequency of contacts between patient and physician
Tidsram: 9 and 18 months
|
9 and 18 months
|
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Patient's perception of ICD therapy
Tidsram: 9 and 18 months
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9 and 18 months
|
|
Patient mobility
Tidsram: 9 and 18 months
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9 and 18 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Matthias Wilhelm, Dr. Med., University Hospital Inselspital, Berne
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- HS033
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