21 and older, any sex, with Atrial Fibrillation or Familial Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Days CoveredPrimary· 12 months
Proportion of Days Covered (PDC), obtained from collection of electronic prescription and pharmacy fill data, and defined as the proportion of availability of medication for the period of interest. PDC range is 0 to 1.00 with higher values indicating greater proportion of days with medication as indicated by pharmacy records.
Group
Value
95% CI
Intervention
.97
0.89 – 1.00
Usual Care
0.97
0.92 – 1.00
Self-reported AdherencePrimary· 4, 8, and 12 months
Self-reported adherence to oral anticoagulation. 3-item instrument with range 1-5 such that lower scores indicate more frequent medication adherence. Here the score is dichotomized by classifying participants reporting 1 for all three items as adherent and those that reported ≥ 2 on any item as non-adherent.
Adherence-4 Months
Group
Value
95% CI
Intervention
112
Usual Care
107
Intervention
5
Usual Care
14
Adherence-8 Months
Group
Value
95% CI
Intervention
106
Usual Care
93
Intervention
8
Usual Care
25
Adherence-12 Months
Group
Value
95% CI
Intervention
104
Usual Care
98
Intervention
10
Usual Care
17
Atrial Fibrillation Effect on Quality of Life (AFEQT)Secondary· 4, 8, and 12 months
The AFEQT is a widely used measure of atrial fibrillation-specific health-related quality of life which consists of a global score and 4 domains (symptoms, daily activities, treatment concerns, and treatment satisfaction). Overall or subscale scores range from 0-100 with higher scores indicating superior health-related quality of life in AF. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all qu
Overall Score : 4-month
Group
Value
95% CI
Intervention
77.8
60.2 – 88.0
Usual Care
75.9
63.0 – 90.7
Overall Score : 8-month
Group
Value
95% CI
Intervention
81.5
63.9 – 92.6
Usual Care
79.6
66.7 – 93.5
Overall Score: 12-month
Group
Value
95% CI
Intervention
80.6
63.9 – 88.9
Usual Care
77.8
62.0 – 90.7
Symptoms : 4-month
Group
Value
95% CI
Intervention
87.5
70.8 – 95.8
Usual Care
91.7
75.0 – 100.0
Symptoms : 8-month
Group
Value
95% CI
Intervention
91.7
75.0 – 100.0
Usual Care
91.7
79.2 – 100.0
Symptoms : 12-month
Group
Value
95% CI
Intervention
91.7
70.8 – 100.0
Usual Care
91.7
75.0 – 100.0
Daily Activities : 4-month
Group
Value
95% CI
Intervention
70.8
41.7 – 85.4
Usual Care
68.8
50.0 – 89.6
Daily Activities : 8-month
Group
Value
95% CI
Intervention
75.0
54.2 – 91.7
Usual Care
75.00
54.2 – 93.8
Patient-Reported Outcomes Measurement Information System (PROMIS)-29Secondary· 4, 8, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 assesses 7 domains (physical function; depression and sadness; pain interference; satisfaction with participation in social roles and activities; fatigue; anxiety and fear; sleep disturbance), 4 questions each, and Pain Intensity with a single item. The 7 domain scores are transformed using a T-score with a mean of 50, standard deviation of 10, in a referent population. Higher scores indicate worse health for the depression, pain, fatigue, anxiety/sleep domains, while higher scores indicate better health for the physical func
Physical Function: 4 month
Group
Value
95% CI
Intervention
41.4
35.8 – 47.6
Usual Care
41.8
36.9 – 56.9
Physical Function: 8 month
Group
Value
95% CI
Intervention
41.9
37.6 – 56.9
Usual Care
42.1
37.6 – 48.1
Physical Function: 12 month
Group
Value
95% CI
Intervention
41.4
36.4 – 48.2
Usual Care
41.7
36.4 – 56.9
Depression and Sadness: 4 month
Group
Value
95% CI
Intervention
48.9
41.0 – 55.5
Usual Care
41.0
41.0 – 54.3
Depression and Sadness: 8 month
Group
Value
95% CI
Intervention
41.0
41.0 – 53.0
Usual Care
41.0
41.0 – 53.0
Depression and Sadness: 12 month
Group
Value
95% CI
Intervention
41.0
41.0 – 55.5
Usual Care
41.0
41.0 – 55.5
Pain Interference: 4 month
Group
Value
95% CI
Intervention
55.7
41.6 – 61.3
Usual Care
54.85
41.6 – 61.3
Pain Interference: 8 month
Group
Value
95% CI
Intervention
54.5
41.6 – 60.0
Usual Care
54.4
41.6 – 59.9
Emergency Room VisitsSecondary· 12 months
The number of participants with 1 or more emergency room visits will be quantified at 12 months. Data will be used to compare health care utilization between the two study arms.
Participants with no ER visits
Group
Value
95% CI
Intervention
92
Usual Care
92
Participants with 1 or more ER visits
Group
Value
95% CI
Intervention
43
Usual Care
43
Hospital AdmissionsSecondary· 12 months
The number of participants with one or more hospitalization will be quantified at 12 months. Data will be used to compare health care utilization between the two study arms.
Participants with no hospital admission
Group
Value
95% CI
Intervention
99
Usual Care
103
Participants with 1 or more hospital admissions
Group
Value
95% CI
Intervention
36
Usual Care
32
Adverse events — posted to ClinicalTrials.gov
Time frame: Data collection occurred from date of consent through the participants 12-month visit..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Atrial fibrillation (AF) is a highly prevalent, morbid condition. Anticoagulation to prevent thromboembolic strokes is a foremost priority in AF but adherence is challenging for patients and lapses in anticoagulation are common. Chronic disease self-management (CDSM) is a recognized program to enhance self-efficacy and improve adherence, quality of life, and patient-centered health outcomes. Rural patients with AF experience increased vulnerability to adverse outcomes due to geographic and social isolation, poor health care access, and limited health literacy. This study uses an innovative, scalable CDSM intervention to improve anticoagulation adherence in rural patients with AF.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
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· NA
· recruiting
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· NA
· recruiting
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· recruiting
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· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pittsburgh
Last refreshed: 30 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04076020.