Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation
- Registration Number
- NCT03187197
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To describe the treatment perception from patients with non-valvular atrial fibrillation (NVAF) receiving Pradaxa® or VKA for stroke prevention by using the self-estimation questionnaire of PACT-Q during a 6-month study period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1315
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort A Pradaxa® consented patients with NVAF in Taiwan with a previous VKA therapy, followed by switching to Pradaxa® Cohort B Pradaxa® patients being newly diagnosed with NVAF and initiated on Pradaxa®
- Primary Outcome Measures
Name Time Method Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups Visit 2 (30-45 days after initiation on Pradaxa® or VKA) and Visit 3 (150-210 days after initiation on Pradaxa® or VKA). The PACT-Q2 was 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 were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching (PSM) method was used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group was summarized and used for comparison.
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 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®). The PACT-Q was 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 was 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 were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores were more favorable. The two dimension scores were presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
- Secondary Outcome Measures
Name Time Method Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment Visit 2 (30-45 days after initiation on Pradaxa®) and Visit 3 (150-210 days after initiation on Pradaxa®). The PACT-Q2 was 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 were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were 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 was 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 were: Q1: How confident are you that your anticoagulant treatment will prevent blood clots? Q2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? Q3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? Q4: How important is it for you to have an anticoagulant treatment that is easy to take? Q5: How concerned are you about making mistakes when taking your anticoagulant treatment? Q6: How important is it for you to take care of your anticoagulant treatment by yourself? Q7: 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 (24)
China Medical University Hospital
🇨🇳Taichung, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Show Chwan Memorial Hospital
🇨🇳Changhua, Taiwan
National Taiwan University Hospital-Hsin-Chu Branch
🇨🇳Hsinchu, Taiwan
Chang Gung Memorial Hospital(TaoYuan)
🇨🇳Taoyuan, Taiwan
Shin Kong International HealthCare Center
🇨🇳Taipei, Taiwan
Chia-Yi Christian Hospital
🇨🇳Chia-Yi City, Taiwan
Chang-Hua Christian Hospital
🇨🇳Changhua, Taiwan
Hsinchu MacKay Memorial Hospital
🇨🇳Hsinchu, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
E-Da Hospital
🇨🇳Kaohsiung, Taiwan
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taipei Medical University-Shuang Ho Hospital
🇨🇳New Taipei City, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
NCKUH
🇨🇳Tainan, Taiwan
Chi Mei Medical Center
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Tainan Municipal An-Nan Hospital
🇨🇳Tainan, Taiwan
Taipe Veterans General Hospital
🇨🇳Taipei City, Taiwan
Taipei Medical University Hospital
🇨🇳Taipei City, Taiwan
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
National Taiwan University Hospital Yun-Lin Branch
🇨🇳Yunlin County, Taiwan
Taipei Municipal Wanfang Hospital
🇨🇳Taipei, Taiwan