Smoking Cessation Interventions in Stroke Patients
Comparison of Smoking Cessation Interventions of Different Intensities in Patients With First Ever Ischemic Stroke.
調査の概要
状態
条件
詳細な説明
BACKGROUND: It is well known, that continued smoking after stroke increases the risk of death and stroke recurrence within a few years after the first stroke. Searching for more efficient methods of antismoking interventions is therefore justified.
OBJECTIVES: The primary objective of the present study is to compare the effectiveness of three anti-smoking interventions of different intensities.
DESIGN: Randomized, controlled trial.
METHODS: Study participants will be recruited among patients of neurological clinics of Institute of Psychiatry and Neurology, hospitalized because of their first in a lifetime ischemic stroke. All stroke patients will be screened regarding their smoking status. The subjects will be patients smoking cigarettes immediately before their first-ever stroke, able to understand the research protocol procedures and able to cooperate during the investigation.
Antismoking interventions will be based on the "5A's" method. Study participants will be randomized to one of three interventions differing in follow-up intensity.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Warsaw、ポーランド、02-957
- 募集
- Institute of Psychiatry and Neurology
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コンタクト：
- Will
- 電話番号：+48224582548
- メール：neurol1@ipin.edu.pl
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主任研究者：
- Halina Sienkiewicz-Jarosz, M.D., PhD
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副調査官：
- Przemysław Bienkowski, M.D., Prof.
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副調査官：
- Magdalena Restel, M.D.
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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:
- Patients smoking immediately prior to stroke
- The first in the lifetime ischemic stroke
- Ability to understand the research protocol procedures and cooperation during the investigation
- Reported availability of and declaration to participate in follow-up
- Informed consent to participate in the study
Exclusion Criteria:
- Severe stroke
- Stroke onset more than 3 weeks before admission
- History of previous stroke with clinical symptoms
- Hemorrhagic stroke
- Diagnosis of dementia or presence of other neurological disease (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, Huntington's chorea, a previous subarachnoid haemorrhage, meningitis, cerebral trauma in an interview)
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：防止
- 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：Antismoking intervention with minimal early follow-up
an intervention according to the "5A's" model with one follow-up visit within one week after discharge from the hospital; follow-up assessment will include two visits: 3 and 12 months after stroke
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Anti-smoking intervention in line with the "5A's" method (Ask, Advice, Assess, Assist, Arrange follow-up.
The intervention will be carried out 5-7 days after stroke, before the planned discharge from the hospital.
Seven days after discharge from a stroke unit a brief telephone/personal advice will be given aimed to motivate patients to quit smoking; follow-up assessment will include two visits: 3 and 12 months after stroke
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アクティブコンパレータ：Antismoking intervention with no early follow-up
an anti-smoking intervention in line with the "5A's" method without early follow-up; follow-up assessment will be limited to two visits: 3 and 12 months after stroke
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an anti-smoking intervention in line with the "5A's" method without early follow-up; follow-up assessment will be limited to two visits: 3 and 12 months after stroke
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実験的：Antismoking intervention with intensive early follow-up
an anti-smoking intervention in line with the "5A's" method will be given, including four follow-up visits within 6 weeks after discharge from the hospital (week 1, week 2, week 4, week 6 after stroke); follow-up assessment will include two visits: 3 and 12 months after stroke
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an anti-smoking intervention in line with the "5A's" method will be given, including four follow-up visits within 6 weeks after discharge from the hospital (week 1, week 2, week 4, week 6 after stroke); follow-up assessment will include two visits: 3 and 12 months after stroke
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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 |
|---|---|
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Smoking cessation rate
時間枠：12 months
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12 months
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協力者と研究者
捜査官
- 主任研究者：Halina Sienkiewicz-Jarosz, M.D., PhD、1st Department of Neurology, Institute of Psychiatry and Neurology, 9 Sobieskiego Str., 02-957 Warsaw, Poland
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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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