Patient Convenience Study
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT02597920
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1852
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment 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).
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups 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.
Patient Characterization at Baseline - Categorical Parameters 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).
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score 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.
Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration Baseline Vitamin K Antagonist (VKA) treatment duration at baseline is only applicable for Cohort A patients and is one of the baseline patient characteristics.
Patient Characterization at Baseline - Creatinine Clearance Baseline Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.
- Secondary Outcome Measures
Name Time Method Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment 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).
Description of PACT-Q1 Items for Patients in Cohort B at Baseline 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).
Trial Locations
- Locations (148)
1160.247.1019 Boehringer Ingelheim Investigational Site
🇧🇪Braine-l'Alleud, Belgium
1160.247.1018 Boehringer Ingelheim Investigational Site
🇧🇪Brussel, Belgium
1160.247.1020 Boehringer Ingelheim Investigational Site
🇧🇪Brussels, Belgium
1160.247.1013 Boehringer Ingelheim Investigational Site
🇧🇪De Pinte, Belgium
1160.247.1001 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
1160.247.1010 Boehringer Ingelheim Investigational Site
🇧🇪Dendermonde, Belgium
1160.247.1011 Boehringer Ingelheim Investigational Site
🇧🇪Diest, Belgium
1160.247.1014 Boehringer Ingelheim Investigational Site
🇧🇪Edegem, Belgium
1160.247.1015 Boehringer Ingelheim Investigational Site
🇧🇪Meise, Belgium
1160.247.1007 Boehringer Ingelheim Investigational Site
🇧🇪Leuven, Belgium
1160.247.1021 Boehringer Ingelheim Investigational Site
🇧🇪Lier, Belgium
1160.247.1002 Boehringer Ingelheim Investigational Site
🇧🇪Maaseik, Belgium
1160.247.1008 Boehringer Ingelheim Investigational Site
🇧🇪Mol, Belgium
1160.247.1016 Boehringer Ingelheim Investigational Site
🇧🇪Mol, Belgium
1160.247.1005 Boehringer Ingelheim Investigational Site
🇧🇪Mons, Belgium
1160.247.1009 Boehringer Ingelheim Investigational Site
🇧🇪Nijlen, Belgium
1160.247.1003 Boehringer Ingelheim Investigational Site
🇧🇪Ottignies - Louvain-la-neuve, Belgium
1160.247.1012 Boehringer Ingelheim Investigational Site
🇧🇪Roeselare, Belgium
1160.247.1017 Boehringer Ingelheim Investigational Site
🇧🇪Tienen, Belgium
1160.247.2005 Boehringer Ingelheim Investigational Site
🇩🇰Nykøbing F, Denmark
1160.247.2009 Boehringer Ingelheim Investigational Site
🇩🇰Roskilde, Denmark
1160.247.2004 Boehringer Ingelheim Investigational Site
🇩🇰Svendborg, Denmark
1160.247.3410 Boehringer Ingelheim Investigational Site
🇬🇷Agrinio, Greece
1160.247.3306 Boehringer Ingelheim Investigational Site
🇬🇷Alexandroupoli, Greece
1160.247.3411 Boehringer Ingelheim Investigational Site
🇬🇷Arta, Greece
1160.247.3100 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3101 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3102 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3104 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3103 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3105 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3107 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3106 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3108 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3109 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3113 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3114 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3116 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3120 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3121 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3200 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3202 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3203 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3204 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3206 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3212 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3213 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3218 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3214 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3316 Boehringer Ingelheim Investigational Site
🇬🇷Chalkidiki, Greece
1160.247.3219 Boehringer Ingelheim Investigational Site
🇬🇷Chania, Greece
1160.247.3315 Boehringer Ingelheim Investigational Site
🇬🇷Drama, Greece
1160.247.3216 Boehringer Ingelheim Investigational Site
🇬🇷Glyfada, Athens, Greece
1160.247.3307 Boehringer Ingelheim Investigational Site
🇬🇷Giannitsa, Greece
1160.247.3215 Boehringer Ingelheim Investigational Site
🇬🇷Hrakleion ,Crete, Greece
1160.247.3400 Boehringer Ingelheim Investigational Site
🇬🇷Ioannina, Greece
1160.247.3408 Boehringer Ingelheim Investigational Site
🇬🇷Ioannina, Greece
1160.247.3402 Boehringer Ingelheim Investigational Site
🇬🇷Kalamata, Greece
1160.247.3407 Boehringer Ingelheim Investigational Site
🇬🇷Karditsa, Greece
1160.247.3317 Boehringer Ingelheim Investigational Site
🇬🇷Serres, Greece
1160.247.3416 Boehringer Ingelheim Investigational Site
🇬🇷Patra, Greece
1160.247.3300 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1160.247.3303 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1160.247.3305 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1160.247.3406 Boehringer Ingelheim Investigational Site
🇬🇷Trikala, Greece
1160.247.3403 Boehringer Ingelheim Investigational Site
🇬🇷Tripoli, Greece
1160.247.3314 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1160.247.3401 Boehringer Ingelheim Investigational Site
🇬🇷Volos, Greece
1160.247.3405 Boehringer Ingelheim Investigational Site
🇬🇷Xanthi, Greece
1160.247.3310 Boehringer Ingelheim Investigational Site
🇬🇷Veroia, Greece
1160.247.3413 Boehringer Ingelheim Investigational Site
🇬🇷Xilokastro, Greece
1160.247.4002 Boehringer Ingelheim Investigational Site
🇳🇱Den Haag, Netherlands
1160.247.4009 Boehringer Ingelheim Investigational Site
🇳🇱Goes, Netherlands
1160.247.4001 Boehringer Ingelheim Investigational Site
🇳🇱Groningen, Netherlands
1160.247.4008 Boehringer Ingelheim Investigational Site
🇳🇱Heerenveen, Netherlands
1160.247.4012 Boehringer Ingelheim Investigational Site
🇳🇱Heerlen, Netherlands
1160.247.4011 Boehringer Ingelheim Investigational Site
🇳🇱Schiedam, Netherlands
1160.247.4003 Boehringer Ingelheim Investigational Site
🇳🇱Veldhoven, Netherlands
1160.247.4005 Boehringer Ingelheim Investigational Site
🇳🇱Nijmegen, Netherlands
1160.247.5005 Boehringer Ingelheim Investigational Site
🇳🇴Oslo, Norway
1160.247.6013 Boehringer Ingelheim Investigational Site
🇵🇹Horta, Portugal
1160.247.6006 Boehringer Ingelheim Investigational Site
🇵🇹Guimarães, Portugal
1160.247.6008 Boehringer Ingelheim Investigational Site
🇵🇹Viana do Castelo, Portugal
1160.247.6002 Boehringer Ingelheim Investigational Site
🇵🇹Matosinhos, Portugal
1160.247.6005 Boehringer Ingelheim Investigational Site
🇵🇹Vila Franca de Xira, Portugal
1160.247.7016 Boehringer Ingelheim Investigational Site
🇸🇪Bandhagen, Sweden
1160.247.7013 Boehringer Ingelheim Investigational Site
🇸🇪Broby, Sweden
1160.247.7006 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1160.247.7011 Boehringer Ingelheim Investigational Site
🇸🇪Hässleholm, Sweden
1160.247.7014 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1160.247.7005 Boehringer Ingelheim Investigational Site
🇸🇪Malmö, Sweden
1160.247.7002 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1160.247.7003 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1160.247.7004 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1160.247.7010 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1160.247.7017 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1160.247.7009 Boehringer Ingelheim Investigational Site
🇸🇪Värnamo, Sweden
1160.247.7015 Boehringer Ingelheim Investigational Site
🇸🇪Västerås, Sweden
1160.247.4004 Boehringer Ingelheim Investigational Site
🇳🇱Amsterdam, Netherlands
1160.247.4010 Boehringer Ingelheim Investigational Site
🇳🇱Beugen, Netherlands
1160.247.4013 Boehringer Ingelheim Investigational Site
🇳🇱Capelle A/d Ijssel, Netherlands
1160.247.4006 Boehringer Ingelheim Investigational Site
🇳🇱EDE, Netherlands
1160.247.4007 Boehringer Ingelheim Investigational Site
🇳🇱Uden, Netherlands
1160.247.3119 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3110 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3111 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3118 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3122 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3207 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3208 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3211 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3217 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1160.247.3201 Boehringer Ingelheim Investigational Site
🇬🇷Ierapetra, Crete, Greece
1160.247.3409 Boehringer Ingelheim Investigational Site
🇬🇷Ioannina, Greece
1160.247.3318 Boehringer Ingelheim Investigational Site
🇬🇷Katerini, Greece
1160.247.3312 Boehringer Ingelheim Investigational Site
🇬🇷Kavala, Greece
1160.247.3404 Boehringer Ingelheim Investigational Site
🇬🇷Kerkyra, Greece
1160.247.3320 V.Pavlou 21 , Komotini
🇬🇷Komotini, Greece
1160.247.3415 Boehringer Ingelheim Investigational Site
🇬🇷Larissa, Greece
1160.247.3412 Boehringer Ingelheim Investigational Site
🇬🇷Patra, Greece
1160.247.3301 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1160.247.3304 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1160.247.3308 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1160.247.3309 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1160.247.3313 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1160.247.3319 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1160.247.2006 Boehringer Ingelheim Investigational Site
🇩🇰Frederikssund, Denmark
1160.247.2008 Boehringer Ingelheim Investigational Site
🇩🇰Herning, Denmark
1160.247.2001 Sygehus Vendsyssel
🇩🇰Hjørring, Denmark
1160.247.2007 Hvidovre Hospital
🇩🇰Hvidovre, Denmark
1160.247.2003 Boehringer Ingelheim Investigational Site
🇩🇰Næstved, Denmark
1160.247.7007 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1160.247.7019 Boehringer Ingelheim Investigational Site
🇸🇪Kristianstad, Sweden
1160.247.7001 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1160.247.7008 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1160.247.7012 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1160.247.5007 Boehringer Ingelheim Investigational Site
🇳🇴Førde, Norway
1160.247.5008 Boehringer Ingelheim Investigational Site
🇳🇴Lierskogen, Norway
1160.247.6012 Boehringer Ingelheim Investigational Site
🇵🇹Angra do Heroísmo, Portugal
1160.247.6009 Boehringer Ingelheim Investigational Site
🇵🇹Penafiel, Portugal
1160.247.5009 Boehringer Ingelheim Investigational Site
🇳🇴Nesbru, Norway
1160.247.5004 Boehringer Ingelheim Investigational Site
🇳🇴Oslo, Norway
1160.247.5010 Boehringer Ingelheim Investigational Site
🇳🇴Stavanger, Norway
1160.247.5006 Boehringer Ingelheim Investigational Site
🇳🇴Svelvik, Norway
1160.247.5001 Boehringer Ingelheim Investigational Site
🇳🇴Bergen, Norway
1160.247.6003 Boehringer Ingelheim Investigational Site
🇵🇹Amadora, Portugal
1160.247.6007 Boehringer Ingelheim Investigational Site
🇵🇹Aveiro, Portugal
1160.247.6004 Boehringer Ingelheim Investigational Site
🇵🇹Braga, Portugal