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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Ried、オーストリア、4910
- Krankenhaus der Barmherzigen Schwestern Ried
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Wien、オーストリア、1140
- Hanusch-Krankenhaus
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Zürich、スイス
- Universitätsklinikum
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Coswig、ドイツ、06869
- Herzzentrum Coswig
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Erlangen、ドイツ、91054
- Universitätsklinikum Erlangen
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Nuernberg、ドイツ、90491
- Krankenhaus Martha-Maria Nürnberg
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Würzburg、ドイツ、97080
- Universitätsklinikum Würzburg
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Home Monitoring On
Home Monitoring activated after implantation (Intervention HM On)
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Home Monitoring activated after implantation
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Hospital Anxiety and Depression Scale (HADS) anxiety score
時間枠：9 and 18 months
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9 and 18 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
HADS depression score
時間枠：9 and 18 months
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9 and 18 months
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Quality of life (SF-12)
時間枠：9 and 18 months
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9 and 18 months
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Prevalence of Type D personality among ICD patients
時間枠：9 and 18 months
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9 and 18 months
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Frequency of contacts between patient and physician
時間枠：9 and 18 months
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9 and 18 months
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Patient's perception of ICD therapy
時間枠：9 and 18 months
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9 and 18 months
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Patient mobility
時間枠：9 and 18 months
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9 and 18 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Matthias Wilhelm, Dr. Med.、University Hospital Inselspital, Berne
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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