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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Zürich, Sveits
- 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, Østerrike, 4910
- Krankenhaus der Barmherzigen Schwestern Ried
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Wien, Østerrike, 1140
- Hanusch-Krankenhaus
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Home Monitoring On
Home Monitoring activated after implantation (Intervention HM On)
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Home Monitoring activated after implantation
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Eksperimentell: Home Monitoring Off
Home Monitoring activated 9 months after implantation (Intervention HM Off)
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Home Monitoring activated 9 months after implantation
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Hospital Anxiety and Depression Scale (HADS) anxiety score
Tidsramme: 9 and 18 months
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9 and 18 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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HADS depression score
Tidsramme: 9 and 18 months
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9 and 18 months
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Quality of life (SF-12)
Tidsramme: 9 and 18 months
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9 and 18 months
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Prevalence of Type D personality among ICD patients
Tidsramme: 9 and 18 months
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9 and 18 months
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Frequency of contacts between patient and physician
Tidsramme: 9 and 18 months
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9 and 18 months
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Patient's perception of ICD therapy
Tidsramme: 9 and 18 months
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9 and 18 months
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Patient mobility
Tidsramme: 9 and 18 months
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9 and 18 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Matthias Wilhelm, Dr. Med., University Hospital Inselspital, Berne
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- HS033
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