このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Patient Convenience Study

2018年10月8日 更新者:Boehringer Ingelheim

Non-interventional Study Describing Patients' Perception on Anticoagulant Treatment and Treatment Convenience When Treated With Pradaxa or Vitamin K Antagonist for Stroke Prophylaxis in Atrial Fibrillation

The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).

調査の概要

状態

完了

条件

研究の種類

観察的

入学 (実際)

1852

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Amsterdam、オランダ
        • 1160.247.4004 Boehringer Ingelheim Investigational Site
      • Beugen、オランダ
        • 1160.247.4010 Boehringer Ingelheim Investigational Site
      • Capelle A/d Ijssel、オランダ
        • 1160.247.4013 Boehringer Ingelheim Investigational Site
      • Den Haag、オランダ
        • 1160.247.4002 Boehringer Ingelheim Investigational Site
      • EDE、オランダ
        • 1160.247.4006 Boehringer Ingelheim Investigational Site
      • Goes、オランダ
        • 1160.247.4009 Boehringer Ingelheim Investigational Site
      • Groningen、オランダ
        • 1160.247.4001 Boehringer Ingelheim Investigational Site
      • Heerenveen、オランダ
        • 1160.247.4008 Boehringer Ingelheim Investigational Site
      • Heerlen、オランダ
        • 1160.247.4012 Boehringer Ingelheim Investigational Site
      • Nijmegen、オランダ
        • 1160.247.4005 Boehringer Ingelheim Investigational Site
      • Schiedam、オランダ
        • 1160.247.4011 Boehringer Ingelheim Investigational Site
      • Uden、オランダ
        • 1160.247.4007 Boehringer Ingelheim Investigational Site
      • Veldhoven、オランダ
        • 1160.247.4003 Boehringer Ingelheim Investigational Site
      • Agrinio、ギリシャ
        • 1160.247.3410 Boehringer Ingelheim Investigational Site
      • Alexandroupoli、ギリシャ
        • 1160.247.3306 Boehringer Ingelheim Investigational Site
      • Arta、ギリシャ
        • 1160.247.3411 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3100 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3101 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3102 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3103 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3104 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3105 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3106 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3107 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3108 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3109 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3110 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3111 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3113 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3114 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3116 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3118 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3119 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3120 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3121 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3122 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3200 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3202 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3203 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3204 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3206 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3207 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3208 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3211 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3212 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3213 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3214 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3217 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 1160.247.3218 Boehringer Ingelheim Investigational Site
      • Chalkidiki、ギリシャ
        • 1160.247.3316 Boehringer Ingelheim Investigational Site
      • Chania、ギリシャ
        • 1160.247.3219 Boehringer Ingelheim Investigational Site
      • Drama、ギリシャ
        • 1160.247.3315 Boehringer Ingelheim Investigational Site
      • Giannitsa、ギリシャ
        • 1160.247.3307 Boehringer Ingelheim Investigational Site
      • Glyfada, Athens、ギリシャ
        • 1160.247.3216 Boehringer Ingelheim Investigational Site
      • Hrakleion ,Crete、ギリシャ
        • 1160.247.3215 Boehringer Ingelheim Investigational Site
      • Ierapetra, Crete、ギリシャ
        • 1160.247.3201 Boehringer Ingelheim Investigational Site
      • Ioannina、ギリシャ
        • 1160.247.3400 Boehringer Ingelheim Investigational Site
      • Ioannina、ギリシャ
        • 1160.247.3408 Boehringer Ingelheim Investigational Site
      • Ioannina、ギリシャ
        • 1160.247.3409 Boehringer Ingelheim Investigational Site
      • Kalamata、ギリシャ
        • 1160.247.3402 Boehringer Ingelheim Investigational Site
      • Karditsa、ギリシャ
        • 1160.247.3407 Boehringer Ingelheim Investigational Site
      • Katerini、ギリシャ
        • 1160.247.3318 Boehringer Ingelheim Investigational Site
      • Kavala、ギリシャ
        • 1160.247.3312 Boehringer Ingelheim Investigational Site
      • Kerkyra、ギリシャ
        • 1160.247.3404 Boehringer Ingelheim Investigational Site
      • Komotini、ギリシャ
        • 1160.247.3320 V.Pavlou 21 , Komotini
      • Larissa、ギリシャ
        • 1160.247.3415 Boehringer Ingelheim Investigational Site
      • Patra、ギリシャ
        • 1160.247.3412 Boehringer Ingelheim Investigational Site
      • Patra、ギリシャ
        • 1160.247.3416 Boehringer Ingelheim Investigational Site
      • Serres、ギリシャ
        • 1160.247.3317 Boehringer Ingelheim Investigational Site
      • Thessaloniki、ギリシャ
        • 1160.247.3300 Boehringer Ingelheim Investigational Site
      • Thessaloniki、ギリシャ
        • 1160.247.3301 Boehringer Ingelheim Investigational Site
      • Thessaloniki、ギリシャ
        • 1160.247.3303 Boehringer Ingelheim Investigational Site
      • Thessaloniki、ギリシャ
        • 1160.247.3304 Boehringer Ingelheim Investigational Site
      • Thessaloniki、ギリシャ
        • 1160.247.3305 Boehringer Ingelheim Investigational Site
      • Thessaloniki、ギリシャ
        • 1160.247.3308 Boehringer Ingelheim Investigational Site
      • Thessaloniki、ギリシャ
        • 1160.247.3309 Boehringer Ingelheim Investigational Site
      • Thessaloniki、ギリシャ
        • 1160.247.3313 Boehringer Ingelheim Investigational Site
      • Thessaloniki、ギリシャ
        • 1160.247.3314 Boehringer Ingelheim Investigational Site
      • Thessaloniki、ギリシャ
        • 1160.247.3319 Boehringer Ingelheim Investigational Site
      • Trikala、ギリシャ
        • 1160.247.3406 Boehringer Ingelheim Investigational Site
      • Tripoli、ギリシャ
        • 1160.247.3403 Boehringer Ingelheim Investigational Site
      • Veroia、ギリシャ
        • 1160.247.3310 Boehringer Ingelheim Investigational Site
      • Volos、ギリシャ
        • 1160.247.3401 Boehringer Ingelheim Investigational Site
      • Xanthi、ギリシャ
        • 1160.247.3405 Boehringer Ingelheim Investigational Site
      • Xilokastro、ギリシャ
        • 1160.247.3413 Boehringer Ingelheim Investigational Site
      • Bandhagen、スウェーデン
        • 1160.247.7016 Boehringer Ingelheim Investigational Site
      • Broby、スウェーデン
        • 1160.247.7013 Boehringer Ingelheim Investigational Site
      • Göteborg、スウェーデン
        • 1160.247.7006 Boehringer Ingelheim Investigational Site
      • Göteborg、スウェーデン
        • 1160.247.7007 Boehringer Ingelheim Investigational Site
      • Göteborg、スウェーデン
        • 1160.247.7014 Boehringer Ingelheim Investigational Site
      • Hässleholm、スウェーデン
        • 1160.247.7011 Boehringer Ingelheim Investigational Site
      • Kristianstad、スウェーデン
        • 1160.247.7019 Boehringer Ingelheim Investigational Site
      • Malmö、スウェーデン
        • 1160.247.7005 Boehringer Ingelheim Investigational Site
      • Stockholm、スウェーデン
        • 1160.247.7001 Boehringer Ingelheim Investigational Site
      • Stockholm、スウェーデン
        • 1160.247.7002 Boehringer Ingelheim Investigational Site
      • Stockholm、スウェーデン
        • 1160.247.7003 Boehringer Ingelheim Investigational Site
      • Stockholm、スウェーデン
        • 1160.247.7004 Boehringer Ingelheim Investigational Site
      • Stockholm、スウェーデン
        • 1160.247.7008 Boehringer Ingelheim Investigational Site
      • Stockholm、スウェーデン
        • 1160.247.7010 Boehringer Ingelheim Investigational Site
      • Stockholm、スウェーデン
        • 1160.247.7012 Boehringer Ingelheim Investigational Site
      • Stockholm、スウェーデン
        • 1160.247.7017 Boehringer Ingelheim Investigational Site
      • Värnamo、スウェーデン
        • 1160.247.7009 Boehringer Ingelheim Investigational Site
      • Västerås、スウェーデン
        • 1160.247.7015 Boehringer Ingelheim Investigational Site
      • Frederikssund、デンマーク
        • 1160.247.2006 Boehringer Ingelheim Investigational Site
      • Herning、デンマーク
        • 1160.247.2008 Boehringer Ingelheim Investigational Site
      • Hjørring、デンマーク
        • 1160.247.2001 Sygehus Vendsyssel
      • Hvidovre、デンマーク
        • 1160.247.2007 Hvidovre Hospital
      • Nykøbing F、デンマーク
        • 1160.247.2005 Boehringer Ingelheim Investigational Site
      • Næstved、デンマーク
        • 1160.247.2003 Boehringer Ingelheim Investigational Site
      • Roskilde、デンマーク
        • 1160.247.2009 Boehringer Ingelheim Investigational Site
      • Svendborg、デンマーク
        • 1160.247.2004 Boehringer Ingelheim Investigational Site
      • Bergen、ノルウェー
        • 1160.247.5001 Boehringer Ingelheim Investigational Site
      • Førde、ノルウェー
        • 1160.247.5007 Boehringer Ingelheim Investigational Site
      • Lierskogen、ノルウェー
        • 1160.247.5008 Boehringer Ingelheim Investigational Site
      • Nesbru、ノルウェー
        • 1160.247.5009 Boehringer Ingelheim Investigational Site
      • Oslo、ノルウェー
        • 1160.247.5004 Boehringer Ingelheim Investigational Site
      • Oslo、ノルウェー
        • 1160.247.5005 Boehringer Ingelheim Investigational Site
      • Stavanger、ノルウェー
        • 1160.247.5010 Boehringer Ingelheim Investigational Site
      • Svelvik、ノルウェー
        • 1160.247.5006 Boehringer Ingelheim Investigational Site
      • Braine-l'Alleud、ベルギー
        • 1160.247.1019 Boehringer Ingelheim Investigational Site
      • Brussel、ベルギー
        • 1160.247.1018 Boehringer Ingelheim Investigational Site
      • Brussels、ベルギー
        • 1160.247.1020 Boehringer Ingelheim Investigational Site
      • Bruxelles、ベルギー
        • 1160.247.1001 Boehringer Ingelheim Investigational Site
      • De Pinte、ベルギー
        • 1160.247.1013 Boehringer Ingelheim Investigational Site
      • Dendermonde、ベルギー
        • 1160.247.1010 Boehringer Ingelheim Investigational Site
      • Diest、ベルギー
        • 1160.247.1011 Boehringer Ingelheim Investigational Site
      • Edegem、ベルギー
        • 1160.247.1014 Boehringer Ingelheim Investigational Site
      • Leuven、ベルギー
        • 1160.247.1007 Boehringer Ingelheim Investigational Site
      • Lier、ベルギー
        • 1160.247.1021 Boehringer Ingelheim Investigational Site
      • Maaseik、ベルギー
        • 1160.247.1002 Boehringer Ingelheim Investigational Site
      • Meise、ベルギー
        • 1160.247.1015 Boehringer Ingelheim Investigational Site
      • Mol、ベルギー
        • 1160.247.1008 Boehringer Ingelheim Investigational Site
      • Mol、ベルギー
        • 1160.247.1016 Boehringer Ingelheim Investigational Site
      • Mons、ベルギー
        • 1160.247.1005 Boehringer Ingelheim Investigational Site
      • Nijlen、ベルギー
        • 1160.247.1009 Boehringer Ingelheim Investigational Site
      • Ottignies - Louvain-la-neuve、ベルギー
        • 1160.247.1003 Boehringer Ingelheim Investigational Site
      • Roeselare、ベルギー
        • 1160.247.1012 Boehringer Ingelheim Investigational Site
      • Tienen、ベルギー
        • 1160.247.1017 Boehringer Ingelheim Investigational Site
      • Amadora、ポルトガル
        • 1160.247.6003 Boehringer Ingelheim Investigational Site
      • Angra do Heroísmo、ポルトガル
        • 1160.247.6012 Boehringer Ingelheim Investigational Site
      • Aveiro、ポルトガル
        • 1160.247.6007 Boehringer Ingelheim Investigational Site
      • Braga、ポルトガル
        • 1160.247.6004 Boehringer Ingelheim Investigational Site
      • Guimarães、ポルトガル
        • 1160.247.6006 Boehringer Ingelheim Investigational Site
      • Horta、ポルトガル
        • 1160.247.6013 Boehringer Ingelheim Investigational Site
      • Matosinhos、ポルトガル
        • 1160.247.6002 Boehringer Ingelheim Investigational Site
      • Penafiel、ポルトガル
        • 1160.247.6009 Boehringer Ingelheim Investigational Site
      • Viana do Castelo、ポルトガル
        • 1160.247.6008 Boehringer Ingelheim Investigational Site
      • Vila Franca de Xira、ポルトガル
        • 1160.247.6005 Boehringer Ingelheim Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

European patients with non valvular atrial fibrillation

説明

Inclusion criteria:

Cohort A:

  1. A. Written informed consent prior to participation
  2. A. Female and male patients >= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
  3. A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
  4. A. Patients switched to Pradaxa® according Summary of Product Characteristics and physician's discretion.

OR

Cohort B:

  1. B. Written informed consent prior to participation.
  2. B. Female and male patients >= 18 years of age newly diagnosed with non-valvular atrial fibrillation and no previous treatment for stroke prevention (no use of any oral anticoagulant (OAC) within one year prior to enrolment).
  3. B. Stroke prevention treatment initiated with Pradaxa® or VKA according to Summary of Product Characteristics and physician's discretion.

Exclusion criteria:

  1. Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC).
  2. Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in atrial fibrillation.
  3. Current participation in any clinical trial of a drug or device.
  4. Current participation in an European registry on the use of oral anticoagulation in AF.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:コホート
  • 時間の展望:見込みのある

コホートと介入

グループ/コホート
Switch patients / A
Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.
New AF patients / B
Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).

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
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
時間枠:Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
The PACT-Q is a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores are more favorable. The two dimension scores are presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
時間枠:Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching method is used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group are summarized and used for comparison.
Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
Patient Characterization at Baseline - Categorical Parameters
時間枠:Baseline
Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history and at baseline (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).
Baseline
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score
時間枠:Baseline
CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. CHA2DS2-VASc stroke risk score and HAS-BLED bleeding risk score at baseline are patient characteristics.
Baseline
Patient Characterization at Baseline - Creatinine Clearance
時間枠:Baseline
Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.
Baseline
Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration
時間枠:Baseline
Vitamin K Antagonist (VKA) treatment duration at baseline is only applicable for Cohort A patients and is one of the baseline patient characteristics.
Baseline

二次結果の測定

結果測定
メジャーの説明
時間枠
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
時間枠:Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
時間枠:Baseline
The PACT-Q1 is composed of a single dimension (7 items), covering the expectations of patients regarding their anticoagulant treatment, and was to be administered before treatment initiation. The 7 items are: A1: How confident are you that your anticoagulant treatment will prevent blood clots? A2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? A3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? A4: How important is it for you to have an anticoagulant treatment that is easy to take? A5: How concerned are you about making mistakes when taking your anticoagulant treatment? A6: How important is it for you to take care of your anticoagulant treatment by yourself? A7: How concerned are you about how much you pay for your anticoagulant treatment? Responses ranged from 1 (Not at all) to 5 (Extremely/ Completely/ Very much).
Baseline

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2015年11月11日

一次修了 (実際)

2017年1月30日

研究の完了 (実際)

2017年1月30日

試験登録日

最初に提出

2015年11月4日

QC基準を満たした最初の提出物

2015年11月4日

最初の投稿 (見積もり)

2015年11月5日

学習記録の更新

投稿された最後の更新 (実際)

2019年2月21日

QC基準を満たした最後の更新が送信されました

2018年10月8日

最終確認日

2018年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 1160.247

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。

3
購読する