Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings (BATMAN)
Predischarge Bundle for Patients in Dual Antiplatelet Therapy to Minimize the Negative Impact of Nuisance Bleedings on Quality of Life: a Randomized Controlled Trial.
調査の概要
詳細な説明
Recent studies suggest that bleeding complications have a strong influence on quality of life. During DAPT regimen bleeding complications occur from 5% to 15% of patients. Nuisance bleedings (BARC 1 bleeding) occur more frequently and show a strong influence on quality of life, depression, anxiety and compliance to the treatment.
The aim of the study is to establish if a specific counseling programme might minimize the negative quality of life impact of nuisance bleedings. A computer-generated list will be used to randomize patients in a 1:1 ratio, stratified by age, sex, renal failure and P2Y12 inhibitor, to either the bundle or the control group.
All patients randomized to the control group (standard of care) will receive education from physician regarding dual antiplatelet therapy (DAPT) as part of the routine discharge process.
All patients randomized to the bundle group will receive:
i) a 15-min visit by a member of the research team 24 h prior to the anticipated discharge day. During this visit, a core set of DAPT risks will be addressed. Advantages and side effects of DAPT will be described. The importance of compliance will be discussed. The correct management of side effects (especially BARC 1 bleedings) will be discussed.
ii) a 15-min visit by a member of the research team with a family member living near/with the patient. Advantages and side effects of DAPT will be described. The importance of compliance will be discussed. The correct management of side effects (especially BARC 1 bleedings) will be discussed.
iii) brochure describing advantages, side effects and management of dual antiplatelet therapy. Contemporaneously, the investigators of the study will contact directly by phone and/or mail the general practionnaire of the patient to describe and explain the same topics and the clinical problem of her patient.
iv) availability of phone number to discuss potential side effects of DAPT. In addition, the study coordinator of the study will contact two times by month the patient by phone to assess DAPT compliance and potential BARC 1 bleedings.
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
-
-
Ferrara
-
Cona、Ferrara、イタリア、44124
- University Hospital Of Ferrara
-
-
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:
- signed written informed consent
- hospital admission for ischemic heart disease with clinical indication to coronary artery angiography
- percutaneous coronary intervention and drug eluting stent implantation
- indication to dual antiplatelet therapy for at least 6 months
Exclusion Criteria:
- oral anticoagulant therapy
- bleeding event in the 30 days before the enrolment
- planned surgery
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：支持療法
- 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 |
|---|---|
|
他の：good clinical practice
all patients will receive education from physician regarding management of dual antiplatelet therapy as part of the routine discharge process
|
education from physician regarding dual antiplatelet therapy as part of the routine discharge process
他の名前：
|
|
実験的：bundle group
patients assigned to the bundle group will receive visits and materials as described by the protocol (counseling)
|
visits and materials describing advantages and side effects of dual antiplatelet therapy and their management
他の名前：
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
quality of life
時間枠：1 month
|
quality of life assessment in each patient by EQ-5D questionnaire
|
1 month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
emergency room admission
時間枠：1 month
|
number of access to emergency room service for bleeding
|
1 month
|
|
general practitioner visit
時間枠：1 month
|
number of access to general practitioner for bleeding
|
1 month
|
|
dyspnea occurrence
時間枠：1 month
|
number of patients suffering dyspnoea stratified according P2Y12 inhibitors
|
1 month
|
|
bleeding academic research consortium (BARC) 2-3
時間枠：1 month
|
occurrence of BARC 2-3 complications
|
1 month
|
|
bleeding academic research consortium (BARC) 1
時間枠：1 month
|
occurrence of BARC 1 complications
|
1 month
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ischemic adverse events
時間枠：1 year
|
cumulative incidence of the following ischemic adverse events: cardiac death, myocardial infarction, transient ischemic attack/stroke
|
1 year
|
|
all-cause mortality
時間枠：1 year
|
occurrence of all-cause death
|
1 year
|
|
BARC 1-3
時間枠：1 year
|
occurrence of BARC1-3 complications
|
1 year
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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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