Atrial Fibrillation
Conditions
Brief summary
Lifelong oral anticoagulant (OAC) therapy is the preferred treatment for the prevention of thromboembolic events in the majority of patients with Atrial Fibrillation (AF). Adherence to medication is essential for valid treatment for OAC therapy. The study aims to explore whether the advanced educational intervention would improve the adherence to dabigatran.
Interventions
DRUGDabigatran
Dabigatran
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
Patients can be included if ALL the following criteria are met: 1. Provide written informed consent prior to participation 2. Female or male adult patients aged ≥ 20 years and \< 75 years, newly diagnosed with non-valvular atrial fibrillation (NVAF) within 1 month and has newly prescribed with dabigatran on physician's decision before study enrolment.
Exclusion criteria
Patients should not be included if ANY ONE of the following criteria is met: 1. Contraindication to the use of dabigatran (i.e., active pathological bleeding, history of a serious hypersensitivity reaction to dabigatran \[e.g., anaphylactic reaction or anaphylactic shock\], severely impaired renal function \[Creatinine clearance rate (Ccr) \< 30 mL/min\], hemorrhagic manifestations, bleeding diathesis, mechanical prosthetic heart valve, congenital or acquired coagulation disorders, organic lesions with bleeding tendency, or concomitantly use systemic ketoconazole, cyclosporine, and itraconazole) 2. Participate in other interventional trials currently or in the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention | at 12 months | Number of patients with high adherence to dabigatran treatment at month 12 in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 3, 6, 9, and 12 months | Number of patients with medium adherence to dabigatran treatment at 3, 6, 9, and 12 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A medium adherence was defined as achieving a MMAS-8 score of 6 or 7 points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8. |
| Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 3, 6, 9, and 12 months | Number of patients with low adherence to dabigatran treatment at 3, 6, 9, and 12 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A low adherence was defined as achieving a MMAS-8 score of 0, 1, 2, 3, 4, or 5 points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8. |
| Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 3, 6, 9, and 12 months | Mean Morisky 8-Item Medication Adherence Questionnaire (MMAS-8) score at 3, 6, 9, and 12 months in patients with and without advanced educational intervention. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8. |
| Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention | at 3, 6, and 9 months | Number of patients with high adherence to dabigatran treatment at 3, 6, and 9 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8. |
| Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention | up to 12 months | Number of patients who discontinued treatment with dabigatran and reasons why they discontinued in patients with and without advanced educational intervention. |
| Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention | up to 12 months | Number of patients who switched treatment with dabigatran and reasons why they switched in patients with and without advanced educational intervention |
| Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention | up to 12 months | Number of patients who discontinued treatment with dabigatran in patients with and without advanced educational intervention. |
Countries
Taiwan
Participant flow
Recruitment details
A retrospective cohort data analysis was conducted to assess the impact of an advanced educational intervention on the adherence to dabigatran in newly diagnosed atrial fibrillation adult patients under 75 years old in Taiwan.
Pre-assignment details
Only participants that met all inclusion and none of the exclusion criteria were included. Participants were equally randomized in two cohorts: 'standard of care' and 'standard of care with advanced educational intervention'. Out of the 897 screened participants only 873 met the eligibility criteria and were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care (SOC) Only This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling. | 441 |
| SOC With Advanced Educational Intervention This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention.
The educational intervention was based on material of the Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients and Atrial Fibrillation Patient Care in Hospitals. The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit. | 432 |
| Total | 873 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative problems | 12 | 14 |
| Overall Study | Adverse Event | 12 | 17 |
| Overall Study | Death | 3 | 3 |
| Overall Study | Lost to Follow-up | 69 | 68 |
| Overall Study | Other | 38 | 46 |
| Overall Study | Participant stop Dabigatran during the 12-month study period | 22 | 24 |
| Overall Study | Withdrawal of consent | 16 | 17 |
Baseline characteristics
| Characteristic | SOC With Advanced Educational Intervention | Total | Standard of Care (SOC) Only |
|---|---|---|---|
| Age, Continuous | 64.7 Years STANDARD_DEVIATION 7.49 | 65.0 Years STANDARD_DEVIATION 7.6 | 65.3 Years STANDARD_DEVIATION 7.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Taiwanese | 430 Participants | 871 Participants | 441 Participants |
| Sex: Female, Male Female | 167 Participants | 348 Participants | 181 Participants |
| Sex: Female, Male Male | 265 Participants | 525 Participants | 260 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 441 | 5 / 432 |
| other Total, other adverse events | 0 / 441 | 0 / 432 |
| serious Total, serious adverse events | 4 / 441 | 5 / 432 |
Outcome results
Primary
Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention
Number of patients with high adherence to dabigatran treatment at month 12 in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
Time frame: at 12 months
Population: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention who had high adherence to dabigatran. Arms were mutually exclusive. Only patients with available data were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care (SOC) Only | Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention | 199 Participants |
| SOC With Advanced Educational Intervention | Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention | 181 Participants |
p-value: 0.9701Chi-squared
Secondary
Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
Mean Morisky 8-Item Medication Adherence Questionnaire (MMAS-8) score at 3, 6, 9, and 12 months in patients with and without advanced educational intervention. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
Time frame: At 3, 6, 9, and 12 months
Population: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention. Arms were mutually exclusive. Only patients with available data were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care (SOC) Only | Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 3 months | 7.0 Score on a scale | Standard Deviation 1.65 |
| Standard of Care (SOC) Only | Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 6 months | 7.2 Score on a scale | Standard Deviation 1.41 |
| Standard of Care (SOC) Only | Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 9 months | 7.4 Score on a scale | Standard Deviation 1.25 |
| Standard of Care (SOC) Only | Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 12 months | 7.4 Score on a scale | Standard Deviation 1.21 |
| SOC With Advanced Educational Intervention | Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 12 months | 7.5 Score on a scale | Standard Deviation 1.07 |
| SOC With Advanced Educational Intervention | Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 3 months | 7.0 Score on a scale | Standard Deviation 1.72 |
| SOC With Advanced Educational Intervention | Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 9 months | 7.3 Score on a scale | Standard Deviation 1.27 |
| SOC With Advanced Educational Intervention | Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 6 months | 7.3 Score on a scale | Standard Deviation 1.38 |
Comparison: At 3 months onlyp-value: 0.667Wilcoxon (Mann-Whitney)
Comparison: At 6 months onlyp-value: 0.1285Wilcoxon (Mann-Whitney)
Comparison: At 9 months onlyp-value: 0.7151Wilcoxon (Mann-Whitney)
Comparison: At 12 months onlyp-value: 0.803Wilcoxon (Mann-Whitney)
Secondary
Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention
Number of patients who discontinued treatment with dabigatran and reasons why they discontinued in patients with and without advanced educational intervention.
Time frame: up to 12 months
Population: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention. Arms were mutually exclusive. Only patients with available data were included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care (SOC) Only | Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention | Switched to other treatment | 60 Participants |
| Standard of Care (SOC) Only | Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention | Other | 107 Participants |
| SOC With Advanced Educational Intervention | Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention | Switched to other treatment | 70 Participants |
| SOC With Advanced Educational Intervention | Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention | Other | 111 Participants |
Secondary
Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention
Number of patients who discontinued treatment with dabigatran in patients with and without advanced educational intervention.
Time frame: up to 12 months
Population: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention. Arms were mutually exclusive. Only patients with available data were included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care (SOC) Only | Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention | Yes | 167 Participants |
| Standard of Care (SOC) Only | Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention | No | 225 Participants |
| Standard of Care (SOC) Only | Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention | Not done | 48 Participants |
| SOC With Advanced Educational Intervention | Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention | Yes | 181 Participants |
| SOC With Advanced Educational Intervention | Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention | No | 213 Participants |
| SOC With Advanced Educational Intervention | Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention | Not done | 37 Participants |
Secondary
Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention
Number of patients who switched treatment with dabigatran and reasons why they switched in patients with and without advanced educational intervention
Time frame: up to 12 months
Population: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention and then switched treatment. Arms were mutually exclusive. Only patients with available data were included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care (SOC) Only | Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention | Cost | 1 Participants |
| Standard of Care (SOC) Only | Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention | Inconvenience | 3 Participants |
| Standard of Care (SOC) Only | Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention | Treatment failure | 4 Participants |
| Standard of Care (SOC) Only | Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention | Other reasons | 40 Participants |
| Standard of Care (SOC) Only | Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention | Adverse event | 12 Participants |
| SOC With Advanced Educational Intervention | Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention | Other reasons | 46 Participants |
| SOC With Advanced Educational Intervention | Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention | Adverse event | 13 Participants |
| SOC With Advanced Educational Intervention | Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention | Inconvenience | 3 Participants |
| SOC With Advanced Educational Intervention | Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention | Cost | 0 Participants |
| SOC With Advanced Educational Intervention | Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention | Treatment failure | 8 Participants |
Secondary
Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention
Number of patients with high adherence to dabigatran treatment at 3, 6, and 9 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
Time frame: at 3, 6, and 9 months
Population: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention who had high adherence to dabigatran. Arms were mutually exclusive. Only patients with available data were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care (SOC) Only | Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention | At 3 months | 224 Participants |
| Standard of Care (SOC) Only | Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention | At 6 months | 199 Participants |
| Standard of Care (SOC) Only | Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention | At 9 months | 204 Participants |
| SOC With Advanced Educational Intervention | Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention | At 3 months | 229 Participants |
| SOC With Advanced Educational Intervention | Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention | At 6 months | 218 Participants |
| SOC With Advanced Educational Intervention | Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention | At 9 months | 184 Participants |
Comparison: At 3 months onlyp-value: 0.7376Chi-squared
Comparison: At 6 months onlyp-value: 0.1356Chi-squared
Comparison: At 9 months onlyp-value: 0.68Chi-squared
Secondary
Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
Number of patients with low adherence to dabigatran treatment at 3, 6, 9, and 12 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A low adherence was defined as achieving a MMAS-8 score of 0, 1, 2, 3, 4, or 5 points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
Time frame: At 3, 6, 9, and 12 months
Population: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention who had low adherence to dabigatran. Arms were mutually exclusive. Only patients with available data were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care (SOC) Only | Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 3 months | 56 Participants |
| Standard of Care (SOC) Only | Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 6 months | 35 Participants |
| Standard of Care (SOC) Only | Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 9 months | 28 Participants |
| Standard of Care (SOC) Only | Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 12 months | 22 Participants |
| SOC With Advanced Educational Intervention | Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 12 months | 14 Participants |
| SOC With Advanced Educational Intervention | Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 3 months | 58 Participants |
| SOC With Advanced Educational Intervention | Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 9 months | 25 Participants |
| SOC With Advanced Educational Intervention | Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 6 months | 28 Participants |
Comparison: At 3 months onlyp-value: 0.8509Chi-squared
Comparison: At 6 months onlyp-value: 0.3302Chi-squared
Comparison: At 9 months onlyp-value: 0.9005Chi-squared
Comparison: At 12 months onlyp-value: 0.2789Chi-squared
Secondary
Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
Number of patients with medium adherence to dabigatran treatment at 3, 6, 9, and 12 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A medium adherence was defined as achieving a MMAS-8 score of 6 or 7 points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
Time frame: At 3, 6, 9, and 12 months
Population: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention who had medium adherence to dabigatran. Arms were mutually exclusive. Only patients with available data were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care (SOC) Only | Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 3 months | 83 Participants |
| Standard of Care (SOC) Only | Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 6 months | 66 Participants |
| Standard of Care (SOC) Only | Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 9 months | 52 Participants |
| Standard of Care (SOC) Only | Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 12 months | 50 Participants |
| SOC With Advanced Educational Intervention | Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 12 months | 51 Participants |
| SOC With Advanced Educational Intervention | Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 3 months | 77 Participants |
| SOC With Advanced Educational Intervention | Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 9 months | 53 Participants |
| SOC With Advanced Educational Intervention | Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | At 6 months | 57 Participants |
Comparison: At 12 months onlyp-value: 0.5135Chi-squared
Comparison: At 3 months onlyp-value: 0.5777Chi-squared
Comparison: At 6 months onlyp-value: 0.3313Chi-squared
Comparison: At 9 months onlyp-value: 0.5697Chi-squared