Patient Convenience Study- NIS RELATE
- Conditions
- Atrial Fibrillation
- Interventions
- Registration Number
- NCT02849509
- 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
- 1313
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Switch Patients / A Pradaxa (dabigatran) Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa. New Patients / B Vitamin K antagonist Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).
- Primary Outcome Measures
Name Time Method Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA) Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups.
Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome.
Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the last assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement.Patient Characterization at Baseline - Categorical Parameters Baseline (Visit1) Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).
Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A Baseline (Visit1) Duration of continuous VKA treatment for stroke prevention prior to baseline assessment (Cohort A)
Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA) Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at second assessment compared to baseline assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease \& treatment (2 items), \& anticoagulant treatment satisfaction (7 items). In this outcome the mean convenience \& satisfaction dimension scores of PACT-Q2 at second assessment (Visit 2) were compared with baseline assessment (Visit 1). Within the PACT-Q2, items for convenience \& for burden of disease and treatment were reversed (reversed score = 6 - item score), added together \& rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed \& rescaled on 0-100 scale to determine satisfaction score. High scores are more favorable.
PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from analysis.Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA) Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to baseline assessment. The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). Within the PACT-Q2, 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 were summed and rescaled on a 0-100 scale to determine the satisfaction score. High scores are more favorable.
PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA) Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome.
Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement.
PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.
- Secondary Outcome Measures
Name Time Method Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B Baseline (Visit1) For Cohort B, scores of PACT-Q1 at baseline were summarised descriptively.
The PACT-Q1 is composed of a single dimension (7 items) covering the expectations of patients regarding their anticoagulant treatment and is to be administered before treatment initiation.
The PACT-Q1 scores ranged from 1 (Not at all) to 5 (Extremely/Completely/ Very much).Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score Baseline (Visit1) 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.
CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.Patient Characteristics at Baseline - Creatinine Clearance Baseline (Visit1) Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.
Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score Baseline (Visit1) HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol.
HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome.Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment Second assessment - Visit 2 (7-124 days after initiation on Pradaxa or VKA) and last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA) Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to second assessment.
The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items).
The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3)were compared with the second assessment (Visit 2). Within the PACT-Q2, 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 were summed and rescaled on a 0-100 scale to determine the satisfaction score.
Trial Locations
- Locations (50)
Pusan National Univ. Hosp
🇰🇷Busan, Korea, Republic of
Sejong General Hospital
🇰🇷Bucheon, Korea, Republic of
Harapan Kita National Cardiovascular Center
🇮🇩Jakarta Barat, Indonesia
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
The Catholic University of Korea, Seoul St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Dankook University Hospital
🇰🇷Cheonan, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Korea, Republic of
Rumah Sakit Siloam Lippo Karawaci, Tangerang
🇮🇩Tangerang, Indonesia
Wonkwang University School of Medicine & Hospital
🇰🇷Iksan, Korea, Republic of
VHS Medical Center
🇰🇷Seoul, Korea, Republic of
Rumah Sakit Bina Waluya
🇮🇩Jakarta Timur, Indonesia
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Jeju National University Hospital
🇰🇷Jeju, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Institut Jantung Negara
🇲🇾Kuala Lumpur, Malaysia
Changi General Hospital
🇸🇬Singapore, Singapore
Ramathibodi Hospital
🇹🇭Bangkok, Thailand
Chiangmai University
🇹🇭Chiangmai, Thailand
National Heart Center
🇸🇬Singapore, Singapore
UiTM Sg Buloh Campus
🇲🇾Sg Buloh, Malaysia
King Chulalongkorn Hospital
🇹🇭Bangkok, Thailand
Pramongkutklao Hospital
🇹🇭Bangkok, Thailand
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Kyungpook National Univ. Hosp
🇰🇷Daegu, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejoen, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Wonju Severance Christian Hosp
🇰🇷Wonju, Korea, Republic of
Hospital Sultanah Bahiyah
🇲🇾Alor Setar, Malaysia
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Hospital University Kebangsaan Malaysia
🇲🇾Kuala Lumpur, Malaysia
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
🇲🇾Kuantan, Malaysia
Bhumibol Adulyadej Hospital
🇹🇭Bangkok, Thailand
Thammasat University Hospital
🇹🇭Pathum Tani, Thailand
Inha University Hospital
🇰🇷Incheon, Korea, Republic of