Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation
Patients Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation Impact of Conventional Oral Anticoagulant (OAC) Compared With Novel Oral Anticoagulant (NOAC)
1 other identifier
observational
1,315
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedStudy Start
First participant enrolled
June 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2019
CompletedResults Posted
Study results publicly available
February 24, 2020
CompletedFebruary 24, 2020
February 1, 2020
1 year
June 13, 2017
January 8, 2020
February 11, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
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).
Baseline, Visit 2 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®).
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
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.
Visit 2 (30-45 days after initiation on Pradaxa® or VKA) and Visit 3 (150-210 days after initiation on Pradaxa® or VKA).
Secondary Outcomes (2)
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®).
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
Baseline
Study Arms (2)
Cohort A
consented patients with NVAF in Taiwan with a previous VKA therapy, followed by switching to Pradaxa®
Cohort B
patients being newly diagnosed with NVAF and initiated on Pradaxa®
Interventions
Eligibility Criteria
Patients 20 years of age or older with a diagnosis of non-valvular atrial fibrillation (NVAF).
You may qualify if:
- Cohort A (patients switched from VKA to Pradaxa)
- Written informed consent prior to participation.
- Female or male patients ≥ 20 years of age with a diagnosis of non-valvular atrial fibrillation (NVAF).
- At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
- Patients switched to Pradaxa prior to baseline assessment according to the physician's discretion and the Summary of Product Characteristics (SmPCs)/reimbursement criteria.
- OR Cohort B (patients newly initiated Pradaxa or VKA)
- Written informed consent prior to participation.
- Female or male patients ≥ 20 years of age, newly diagnosed with NVAF, and no previous treatment for stroke prevention (no use of any OAC within 1 year prior to enrolment).
- Patients initiated stroke prevention treatment with Pradaxa or VKA according to the physician's discretion and the SmPCs/reimbursement criteria.
You may not qualify if:
- Contraindication to the use of Pradaxa® or VKA as described in the SmPCs.
- Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in NVAF.
- Current participation in any clinical trial of a drug or device.
- Current participation in an AF-related registry, e.g. the Gloria AF program.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Chang-Hua Christian Hospital
Changhua, 500, Taiwan
Show Chwan Memorial Hospital
Changhua, Taiwan
Chia-Yi Christian Hospital
Chia-Yi City, 40705, Taiwan
Hsinchu MacKay Memorial Hospital
Hsinchu, Taiwan
National Taiwan University Hospital-Hsin-Chu Branch
Hsinchu, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
E-Da Hospital
Kaohsiung City, 824, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Far Eastern Memorial Hospital
New Taipei City, 220, Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 235, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
NCKUH
Tainan, 704, Taiwan
Chi Mei Medical Center
Tainan, 710, Taiwan
Tainan Municipal An-Nan Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Mackay Memorial Hospital
Taipei, 10449, Taiwan
Taipei Medical University Hospital
Taipei, 110, Taiwan
Taipe Veterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
Shin Kong International HealthCare Center
Taipei, Taiwan
Taipei Municipal Wanfang Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital(TaoYuan)
Taoyuan District, 330, Taiwan
National Taiwan University Hospital Yun-Lin Branch
Yunlin County, 632, Taiwan
Related Publications (1)
Lee CW, Liu ME, Lee TM, Chang RY, Huang CY, Hu YF, Yeh HI. Patient satisfaction with dabigatrean and warfarin for stroke prevention in atrial fibrillation: Taiwan PASSION study. J Chin Med Assoc. 2021 Apr 1;84(4):375-382. doi: 10.1097/JCMA.0000000000000496.
PMID: 33784265DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2017
First Posted
June 14, 2017
Study Start
June 20, 2017
Primary Completion
June 30, 2018
Study Completion
January 11, 2019
Last Updated
February 24, 2020
Results First Posted
February 24, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share