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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Coswig, 독일, 06869
- Herzzentrum Coswig
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Erlangen, 독일, 91054
- Universitätsklinikum Erlangen
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Nuernberg, 독일, 90491
- Krankenhaus Martha-Maria Nürnberg
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Würzburg, 독일, 97080
- Universitätsklinikum Würzburg
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Zürich, 스위스
- Universitätsklinikum
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Ried, 오스트리아, 4910
- Krankenhaus der Barmherzigen Schwestern Ried
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Wien, 오스트리아, 1140
- Hanusch-Krankenhaus
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Home Monitoring On
Home Monitoring activated after implantation (Intervention HM On)
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Home Monitoring activated after implantation
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Hospital Anxiety and Depression Scale (HADS) anxiety score
기간: 9 and 18 months
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9 and 18 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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HADS depression score
기간: 9 and 18 months
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9 and 18 months
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Quality of life (SF-12)
기간: 9 and 18 months
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9 and 18 months
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Prevalence of Type D personality among ICD patients
기간: 9 and 18 months
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9 and 18 months
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Frequency of contacts between patient and physician
기간: 9 and 18 months
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9 and 18 months
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Patient's perception of ICD therapy
기간: 9 and 18 months
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9 and 18 months
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Patient mobility
기간: 9 and 18 months
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9 and 18 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Matthias Wilhelm, Dr. Med., University Hospital Inselspital, Berne
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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