Social-software iMproving wARfarin Therapy (SMART)
Randomized Evaluation of Social-software Improving Warfarin Therapy in Patients With Mechanical Heart Valve Replacement
調査の概要
詳細な説明
Social software is becoming a necessary of life. Wechat, powered by Tencent company, is the most popular social software in China. People can chat with others no matter how far away from each other.
Anticoagulation Quality is very important for patients receiving warfarin anticoagulation therapy, which is usually evaluated Time in therapeutic range (TTR). It is reported that TTR is very low (38.8%) in China patients. So we are planning to introduce the social software to set up a bridge for clinicians and their patients, to instruct warfarin therapy. We aim to investigate whether social software could be used to improve warfarin anticoagulation quality of Chinese patients.
We planned to enrol enough eligible patients receiving warfarin therapy due to the mechanical valves in a randomized controlled trial. Warfarin-treated patients were assigned to social software management group ( in which warfarin therapy was guided via the social platform by experienced clinicians) or to the traditional management control group (in which warfarin therapy was managed with traditional model). The primary outcomes the first time to bleeding or thrombotic events, the secondary outcomes were an elevation in time in therapeutic range (TTR) of international normalized ratio (INR), reduction in INR variation and number of extremely high INR results during 18 months.
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
-
-
Hubei
-
Wuhan、Hubei、中国、430000
- WAHH
-
-
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:
- Received mechanical valve replacement;
- Receiving warfarin anticoagulation therapy;
- Have smartphone and Know how to use wechat application and our mini-program;
- be expected to survive for the duration of the study;
- not be suffering from intracranial bleeding (intracranial haemorrhage, subarachnoid haemorrhage, hemorrhagic stroke) or any other contraindication described in the warfarin package insert;
- be willing to be randomized;
- sign the informed consent form;
- not be enrolled in another randomized clinical trial that involves a drug or device intervention.
Exclusion Criteria:
- subject has had an intracranial haemorrhage, subarachnoid haemorrhage, hemorrhagic stroke, or any other absolute/major contraindication described in the warfarin package insert within the last month
- subject enrolled in another randomized clinical trial that involves a drug or device intervention
- subject is not able to follow the protocol and all related instructions and does not have a caregiver with these skills
- Patients were considered being not suitable for this 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 |
|---|---|
|
実験的：Social-software management group
We set up a mini-program based on wechat application.
We instruct warfarin therapy via social-software including dose adjustment, answer questions, remind monitoring INR et.al.
|
Using Wechat application, a social platform, to manage warfarin therapy in patients with mechanical valve replacement.
|
|
介入なし：Routine management group
This is the control group, Warfarin therapy was managed via traditional style without social software intervention.
|
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 |
|---|---|---|
|
Time to First Event
時間枠：Up to 18 months
|
Thrombotic events, such as Valve thrombosis, Stroke, Peripheral embolism; Major bleeding, such as cerebral hemorrhage，gastrointestinal bleeding etc.
|
Up to 18 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time in therapeutic range
時間枠：Up to 18 months
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Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio
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Up to 18 months
|
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Individual variation of International Normalized Ratio (INR)
時間枠：Up to 18 months
|
Standard deviation (SD) of individual INR results
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Up to 18 months
|
|
Times of extremely high International Normalized Ratio (INR) values
時間枠：Up to 18 months
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Times of INR results above 4.0; Times of INR results above 12.0
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Up to 18 months
|
協力者と研究者
捜査官
- スタディディレクター：Zhenlu ZHANG, MD,PhD、Wuhan Asia Heart Hospital
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 (実際)
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
本研究に関する用語
キーワード
その他の研究ID番号
- 2017-P-033
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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