Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Patients Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation Impact of Conventional Oral Anticoagulant (OAC) Compared With Novel Oral Anticoagulant (NOAC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03187197
• Other study ID #: 1160-0286
• Status: Completed
• Start date: June 20, 2017
• Est. completion date: January 11, 2019

Study information

• Verified date: February 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1315
• Est. completion date: January 11, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion criteria:

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.

Exclusion criteria:

• 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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Pradaxa®
Dabigatran etexilate

Locations

Country	Name	City	State
Taiwan	Chang-Hua Christian Hospital	Changhua
Taiwan	Show Chwan Memorial Hospital	Changhua
Taiwan	Chia-Yi Christian Hospital	Chia-Yi City
Taiwan	Hsinchu MacKay Memorial Hospital	Hsinchu
Taiwan	National Taiwan University Hospital-Hsin-Chu Branch	Hsinchu
Taiwan	E-Da Hospital	Kaohsiung
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	Taipei Medical University-Shuang Ho Hospital	New Taipei City
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chi Mei Medical Center	Tainan
Taiwan	NCKUH	Tainan
Taiwan	Tainan Municipal An-Nan Hospital	Tainan
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Shin Kong International HealthCare Center	Taipei
Taiwan	Taipei Municipal Wanfang Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Taipe Veterans General Hospital	Taipei City
Taiwan	Taipei Medical University Hospital	Taipei City
Taiwan	Chang Gung Memorial Hospital(TaoYuan)	Taoyuan
Taiwan	National Taiwan University Hospital Yun-Lin Branch	Yunlin County

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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®).
Primary	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	Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment	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).	Visit 2 (30-45 days after initiation on Pradaxa®) and Visit 3 (150-210 days after initiation on Pradaxa®).
Secondary	Description of PACT-Q1 Items for Patients in Cohort B at 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).	Baseline

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