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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Coswig, Alemanha, 06869
- Herzzentrum Coswig
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Erlangen, Alemanha, 91054
- Universitätsklinikum Erlangen
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Nuernberg, Alemanha, 90491
- Krankenhaus Martha-Maria Nürnberg
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Würzburg, Alemanha, 97080
- Universitätsklinikum Würzburg
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Zürich, Suíça
- Universitätsklinikum
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Ried, Áustria, 4910
- Krankenhaus der Barmherzigen Schwestern Ried
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Wien, Áustria, 1140
- Hanusch-Krankenhaus
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Home Monitoring On
Home Monitoring activated after implantation (Intervention HM On)
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Home Monitoring activated after implantation
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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Hospital Anxiety and Depression Scale (HADS) anxiety score
Prazo: 9 and 18 months
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9 and 18 months
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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HADS depression score
Prazo: 9 and 18 months
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9 and 18 months
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Quality of life (SF-12)
Prazo: 9 and 18 months
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9 and 18 months
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Prevalence of Type D personality among ICD patients
Prazo: 9 and 18 months
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9 and 18 months
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Frequency of contacts between patient and physician
Prazo: 9 and 18 months
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9 and 18 months
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Patient's perception of ICD therapy
Prazo: 9 and 18 months
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9 and 18 months
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Patient mobility
Prazo: 9 and 18 months
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9 and 18 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Matthias Wilhelm, Dr. Med., University Hospital Inselspital, Berne
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- HS033
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