Arrhythmia, Cardiac, Atrial Fibrillation, Familial Atrial Fibrillation, Heart Diseases, Pathologic Processes
Conditions
Keywords
Adherence, Health Literacy, quality of life
Brief summary
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.
Detailed description
This is a randomized clinical trial to evaluate the effect of an embodied conversational agent (ECA) on health outcomes in people with atrial fibrillation. The study will enroll 264 patients who reside in rural, Western Pennsylvania who have atrial fibrillation. Participants will be randomized to the intervention or usual care. Intervention participants will receive a contemporary mobile phone, commonly known and referred to herein as a smartphone, with a relational agent, which simulates conversation and provides coaching, guidance, and assistance with chronic disease self-management. In addition participants will receive an FDA-approved instrument for heart rate and rhythm monitoring, which is named the AliveCor KardiaMobile device (herein referred to as the AliveCor Kardia), that pairs with the relational agent. Usual care participants will receive a smartphone as well, which will have the general health application called WebMD. The intervention will last 4 months and participants will have visits at baseline, 4, 8 and 12 months. The study will evaluate the improvement in adherence to anticoagulation, quality of life, and health care utilization resulting from the intervention.
Interventions
BEHAVIORALRelational agent/AliveCor Kardia - Intervention
Use of the relational agent and Kardia daily for 120 days.
BEHAVIORALUsual Care
Use of the WebMD app daily for 120 days.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Northeastern University
Boston University
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult, age ≥21; 2. Diagnosis of AF, identified from the electronic health record (EHR) problem list and confirmed by 2 or more reports of AF from separate monitoring events at least 2 weeks apart (CG, Holter or event monitor); 3. Prescribed use of warfarin or direct-acting oral anticoagulant (DOAC) for AF stroke prevention; 4. English-speaking well enough to participate in informed consent and this study; 5. No plans to relocate from the area within 12 months of enrollment.
Exclusion criteria
1. Conditions other than AF that require anticoagulation, such as mechanical prosthetic valve, deep vein thrombosis, or pulmonary embolism; 2. History of pulmonary vein isolation or foreseen pulmonary vein isolation; 3. History of atrioventricular (AV) nodal ablation or foreseen AV nodal ablation; 4. Heart failure necessitating hospital admission ≤3 months prior to study inclusion; 5. Acute coronary syndrome (defined as at least 2 of the following: chest pain, ischemic electrocardiographic changes, or troponin ≥0.1 ng/mL) ≤3 months prior to study inclusion; 6. Untreated hyperthyroidism or ≤3 months euthyroidism before inclusion; 7. Foreseen pacemaker, internal cardioverter defibrillator, or cardiac resynchronization therapy; 8. Cardiac surgery ≤3 months before inclusion; 9. Planned cardiac surgery; 10. Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer); 11. Inability to comprehend the study protocol, defined as failing to answer correctly a set of questions on orientation and short-term memory during the consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Days Covered | 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. |
| Self-reported Adherence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atrial Fibrillation Effect on Quality of Life (AFEQT) | 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 questions answered). |
| Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | 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 function and satisfaction domains. The single Pain Intensity item is scored 0 (No pain) to 10 (Worst imaginable pain) in the past 7 days. Further details on PROMIS scoring are available at https://www.healthmeasures.net/images/PROMIS/manuals/PROMIS\_Adult\_Profile\_Scoring\_Manual.pdf. |
| Emergency Room Visits | 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. |
| Hospital Admissions | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited based on physician referral at numerous University of Pittsburgh Medical Center (UPMC) sites located in rural Pennsylvania counties. The first participant was enrolled on January 8th, 2020 and the last participant was enrolled in March 2022.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm Participants received the relational agent and the AliveCor Kardia to use for 120 days.
Participants were directed to use the relational agent and AliveCor Kardia daily.
Relational agent/AliveCor Kardia - Intervention Group: Use of the relational agent and Kardia daily for 120 days. | 135 |
| Usual Care Arm Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.
Participants were directed to use the WebMD application as often as they would like.
Usual Care: Use of the WebMD app daily for 120 days. | 135 |
| Total | 270 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 6 |
| Overall Study | Withdrawal by Subject | 12 | 8 |
Baseline characteristics
| Characteristic | Total | Usual Care Arm | Intervention Arm |
|---|---|---|---|
| AF Effect on Quality-of-Life questionnaire (AFEQT) Daily activities | 66.6 units on a scale STANDARD_DEVIATION 24.2 | 67.1 units on a scale STANDARD_DEVIATION 25 | 66.0 units on a scale STANDARD_DEVIATION 23.6 |
| AF Effect on Quality-of-Life questionnaire (AFEQT) Overall | 74.4 units on a scale STANDARD_DEVIATION 16.1 | 73.7 units on a scale STANDARD_DEVIATION 17 | 75.1 units on a scale STANDARD_DEVIATION 15.1 |
| AF Effect on Quality-of-Life questionnaire (AFEQT) Symptoms | 84.5 units on a scale STANDARD_DEVIATION 16.1 | 83.5 units on a scale STANDARD_DEVIATION 17.1 | 85.5 units on a scale STANDARD_DEVIATION 15 |
| AF Effect on Quality-of-Life questionnaire (AFEQT) Treatment concern | 78.2 units on a scale STANDARD_DEVIATION 18 | 76.1 units on a scale STANDARD_DEVIATION 19.1 | 80.4 units on a scale STANDARD_DEVIATION 16.6 |
| AF Effect on Quality-of-Life questionnaire (AFEQT) Treatment Satisfaction: How well treatment controls symptoms | 80.8 units on a scale STANDARD_DEVIATION 18.3 | 79.0 units on a scale STANDARD_DEVIATION 18.9 | 82.6 units on a scale STANDARD_DEVIATION 17.5 |
| AF Effect on Quality-of-Life questionnaire (AFEQT) Treatment satisfaction: Relief of symptoms | 79.3 units on a scale STANDARD_DEVIATION 20.4 | 77.7 units on a scale STANDARD_DEVIATION 21.6 | 81.0 units on a scale STANDARD_DEVIATION 19 |
| AF History | 6.4 years STANDARD_DEVIATION 7.7 | 7.0 years STANDARD_DEVIATION 8.7 | 5.8 years STANDARD_DEVIATION 6.7 |
| Age, Continuous | 73.1 years | 72.7 years | 73.6 years |
| Alcohol consumption, heavy No | 260 Participants | 130 Participants | 130 Participants |
| Alcohol consumption, heavy Yes | 10 Participants | 5 Participants | 5 Participants |
| Anticoagulant medication used for stroke prevention Direct acting oral anticoagulant | 226 Participants | 113 Participants | 113 Participants |
| Anticoagulant medication used for stroke prevention Warfarin | 44 Participants | 22 Participants | 22 Participants |
| Body Mass Index (BMI) | 33.1 kg/m^2 STANDARD_DEVIATION 8.4 | 33.5 kg/m^2 STANDARD_DEVIATION 8.7 | 32.8 kg/m^2 STANDARD_DEVIATION 8.1 |
| Cohabitation Resides alone | 89 Participants | 40 Participants | 49 Participants |
| Cohabitation Resides with others | 181 Participants | 95 Participants | 86 Participants |
| Education College (Bachelors or higher) | 66 Participants | 40 Participants | 26 Participants |
| Education High school, vocational or trade school or less | 128 Participants | 58 Participants | 70 Participants |
| Education Some College or associate degree | 76 Participants | 37 Participants | 39 Participants |
| Electrical Cardioversion No | 195 Participants | 100 Participants | 95 Participants |
| Electrical Cardioversion Yes | 75 Participants | 35 Participants | 40 Participants |
| Employment Status Currently Working, Part-time or Full-time | 35 Participants | 15 Participants | 20 Participants |
| Employment Status Not Currently Working | 24 Participants | 13 Participants | 11 Participants |
| Employment Status Retired | 211 Participants | 107 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 261 Participants | 130 Participants | 131 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 1 Participants |
| Health Literacy Adequate Health Literacy | 145 Participants | 73 Participants | 72 Participants |
| Health Literacy Limited Health Literacy | 125 Participants | 62 Participants | 63 Participants |
| History of any cardioversion No | 190 Participants | 98 Participants | 92 Participants |
| History of any cardioversion Yes | 80 Participants | 37 Participants | 43 Participants |
| Housing Buying, and Paying mortgage | 47 Participants | 25 Participants | 22 Participants |
| Housing Neither own nor pay rent | 6 Participants | 2 Participants | 4 Participants |
| Housing Own | 185 Participants | 93 Participants | 92 Participants |
| Housing Prefer not to respond | 1 Participants | 1 Participants | 0 Participants |
| Housing Renting | 31 Participants | 14 Participants | 17 Participants |
| Housing ownership status Ownership | 185 Participants | 93 Participants | 92 Participants |
| Housing ownership status Rent or other status | 85 Participants | 42 Participants | 43 Participants |
| Hypertension No | 36 Participants | 18 Participants | 18 Participants |
| Hypertension Yes | 234 Participants | 117 Participants | 117 Participants |
| Marital Status Married or living as married | 181 Participants | 95 Participants | 86 Participants |
| Marital Status Separated or divorced | 28 Participants | 10 Participants | 18 Participants |
| Marital Status Single, not married | 12 Participants | 5 Participants | 7 Participants |
| Marital Status Widowed | 49 Participants | 25 Participants | 24 Participants |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) Anxiety and fear | 50.4 units on a scale | 51.4 units on a scale | 48.2 units on a scale |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) Depression and sadness | 48.9 units on a scale | 48.9 units on a scale | 41.0 units on a scale |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) Fatigue | 51.0 units on a scale | 51.9 units on a scale | 51.0 units on a scale |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain interference | 54.8 units on a scale | 55.7 units on a scale | 53.9 units on a scale |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical function | 41.8 units on a scale | 42.9 units on a scale | 41.7 units on a scale |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) Satisfaction with participation in social roles and activities | 54.8 units on a scale | 55.7 units on a scale | 53.9 units on a scale |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) Sleep disturbance | 51.0 units on a scale | 50.8 units on a scale | 51.0 units on a scale |
| Pharmacologic cardioversion No | 263 Participants | 133 Participants | 130 Participants |
| Pharmacologic cardioversion Yes | 7 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 257 Participants | 128 Participants | 129 Participants |
| Self-reported adherence Adherent | 239 Participants | 119 Participants | 120 Participants |
| Self-reported adherence Non-adherent | 31 Participants | 16 Participants | 15 Participants |
| Sex: Female, Male Female | 163 Participants | 83 Participants | 80 Participants |
| Sex: Female, Male Male | 107 Participants | 52 Participants | 55 Participants |
| Smoking Current Smoker | 17 Participants | 5 Participants | 12 Participants |
| Smoking Never Smoke | 136 Participants | 74 Participants | 62 Participants |
| Smoking Past Smoker | 117 Participants | 56 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 135 | 6 / 135 |
| other Total, other adverse events | 32 / 135 | 40 / 135 |
| serious Total, serious adverse events | 35 / 135 | 31 / 135 |
Outcome results
Primary
Proportion of Days Covered
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.
Time frame: 12 months
Population: Initial data set included 270 participants. 7 cases of no pharmacy data, 12 cases with start date after end date, and 1 case where one fill was available before randomization. PDC was calculated for 250 participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Proportion of Days Covered | .97 Proportion of days covered |
| Usual Care | Proportion of Days Covered | 0.97 Proportion of days covered |
Comparison: Proportion of days covered (PDC) at 12 months. A sample size of 119 in each study arm enabled us to detect a minimum difference in PDC of 11.7% with 85% power (assuming a standard deviation=30%). Our power calculations assume use of 2-sided tests with 0.05 significance level.p-value: 0.99Wilcoxon (Mann-Whitney)
Comparison: Proportion of days covered (PDC) analyzed as a binary variable with optimal adherence determined as ≥0.80) variables using logistic regression and adjustment for trial stratification factors. Our power calculations assume use of 2-sided tests with 0.05 significance level.p-value: <0.05Regression, Logistic
Primary
Self-reported Adherence
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.
Time frame: 4, 8, and 12 months
Population: Intervention 4-month: n=117 (11 withdrawals \[w/d\], 1 death; 4 discontinued \[d/c\] oral anticoagulation \[OAC\]; 2 missed visit) 8-month: n=114 (total 12 w/d, 4 deaths; 3 d/c OAC; 2 missed visit) 12-month: n=114 (total 12 w/d, 4 deaths, 5 d/c OAC)~Control 4-month: n=121 (8 w/d, 4 deaths; 1 d/c OAC; 1 missed visit) 8-month: n=118 (total 8 w/d, 6 deaths; 3 d/c OAC) 12-month: n=115 (total 8 w/d, 6 deaths; 4 d/c OAC; 2 missed visit)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | Self-reported Adherence | Adherence-4 Months | Non-adherent | 5 Participants |
| Intervention | Self-reported Adherence | Adherence-8 Months | Non-adherent | 8 Participants |
| Intervention | Self-reported Adherence | Adherence-12 Months | Adherent | 104 Participants |
| Intervention | Self-reported Adherence | Adherence-8 Months | Adherent | 106 Participants |
| Intervention | Self-reported Adherence | Adherence-12 Months | Non-adherent | 10 Participants |
| Intervention | Self-reported Adherence | Adherence-4 Months | Adherent | 112 Participants |
| Usual Care | Self-reported Adherence | Adherence-12 Months | Non-adherent | 17 Participants |
| Usual Care | Self-reported Adherence | Adherence-4 Months | Adherent | 107 Participants |
| Usual Care | Self-reported Adherence | Adherence-4 Months | Non-adherent | 14 Participants |
| Usual Care | Self-reported Adherence | Adherence-8 Months | Adherent | 93 Participants |
| Usual Care | Self-reported Adherence | Adherence-8 Months | Non-adherent | 25 Participants |
| Usual Care | Self-reported Adherence | Adherence-12 Months | Adherent | 98 Participants |
Comparison: Difference in self-reported adherence reported across baseline, 4-, 8-, and 12-month visits using generalized estimating equations and adjusted for trial stratification factors.p-value: <0.05Regression, Logistic
Secondary
Atrial Fibrillation Effect on Quality of Life (AFEQT)
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 questions answered).
Time frame: 4, 8, and 12 months
Population: Intervention arm:~4-month visit, n=121 (11 withdrawals, 1 death; 2 missed this visit) 8-month visit, n=117 (total 12 withdrawals, 4 deaths; 2 missed this visit) 12-month visit, n=119 (no additional withdrawals, no additional deaths, no missed visit)~Control arm:~4-month visit, n=122 (8 withdrawals, 4 deaths; 1 missed this visit) 8-month visit, n=121 (total 6 deaths; no missed this visit) 12-month visit, n=119 (no additional withdrawals, no additional deaths; 2 missed this visit)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Overall Score : 8-month | 81.5 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Treatment Concern : 4-month | 83.3 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Symptoms : 8-month | 91.7 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Treatment Concern : 8-month | 88.9 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Overall Score : 4-month | 77.8 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Treatment Concern : 12-month | 88.9 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Symptoms : 12-month | 91.7 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Overall Score: 12-month | 80.6 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Satisfaction: Relief of Symptoms: 8-month | 83.3 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Satisfaction: Relief of Symptoms: 4-month | 83.0 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Satisfaction: Relief of Symptoms: 12-month | 83.3 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Daily Activities : 8-month | 75.0 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Satisfaction: Control of Symptoms: 4-month | 83.3 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Symptoms : 4-month | 87.5 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Satisfaction: Control of Symptoms: 8-month | 83.3 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Daily Activities : 12-month | 70.8 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Satisfaction: Control of Symptoms: 12-month | 83.3 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Daily Activities : 4-month | 70.8 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Satisfaction: Control of Symptoms: 12-month | 83.3 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Overall Score : 4-month | 75.9 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Overall Score : 8-month | 79.6 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Overall Score: 12-month | 77.8 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Symptoms : 4-month | 91.7 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Symptoms : 8-month | 91.7 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Symptoms : 12-month | 91.7 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Daily Activities : 4-month | 68.8 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Daily Activities : 8-month | 75.00 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Daily Activities : 12-month | 72.9 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Treatment Concern : 4-month | 83.3 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Treatment Concern : 8-month | 86.1 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Treatment Concern : 12-month | 86.1 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Satisfaction: Relief of Symptoms: 4-month | 83.0 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Satisfaction: Relief of Symptoms: 8-month | 83.3 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Satisfaction: Relief of Symptoms: 12-month | 83.3 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Satisfaction: Control of Symptoms: 4-month | 83.3 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | Satisfaction: Control of Symptoms: 8-month | 83.3 score on a scale |
Secondary
Emergency Room Visits
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.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Emergency Room Visits | Participants with no ER visits | 92 Participants |
| Intervention | Emergency Room Visits | Participants with 1 or more ER visits | 43 Participants |
| Usual Care | Emergency Room Visits | Participants with no ER visits | 92 Participants |
| Usual Care | Emergency Room Visits | Participants with 1 or more ER visits | 43 Participants |
Secondary
Hospital Admissions
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.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Hospital Admissions | Participants with no hospital admission | 99 Participants |
| Intervention | Hospital Admissions | Participants with 1 or more hospital admissions | 36 Participants |
| Usual Care | Hospital Admissions | Participants with no hospital admission | 103 Participants |
| Usual Care | Hospital Admissions | Participants with 1 or more hospital admissions | 32 Participants |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
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 function and satisfaction domains. The single Pain Intensity item is scored 0 (No pain) to 10 (Worst imaginable pain) in the past 7 days. Further details on PROMIS scoring are available at https://www.healthmeasures.net/images/PROMIS/manuals/PROMIS\_Adult\_Profile\_Scoring\_Manual.pdf.
Time frame: 4, 8, and 12 months
Population: Intervention arm:~4-month visit, n=121 (11 withdrawals, 1 death; 2 missed this visit) 8-month visit, n=117 (total 12 withdrawals, 4 deaths; 2 missed this visit) 12-month visit, n=119 (no additional withdrawals, no additional deaths, no missed visit)~Control arm:~4-month visit, n=122 (8 withdrawals, 4 deaths; 1 missed this visit) 8-month visit, n=121 (total 6 deaths; no missed this visit) 12-month visit, n=119 (no additional withdrawals, no additional deaths; 2 missed this visit)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical Function: 4 month | 41.4 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical Function: 8 month | 41.9 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical Function: 12 month | 41.4 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression and Sadness: 4 month | 48.9 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression and Sadness: 8 month | 41.0 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression and Sadness: 12 month | 41.0 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference: 4 month | 55.7 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference: 8 month | 54.5 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference: 12 month | 53.9 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Ability to Participate: 4 month | 51.8 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Ability to Participate: 8 month | 51.8 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety and Fear: 12 month | 48.1 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Ability to Participate: 12 month | 51.8 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Fatigue: 4 month | 51.0 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Fatigue: 8 month | 51.0 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Fatigue: 12 month | 51.0 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety and Fear: 4 month | 48.1 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety and Fear: 8 month | 48.1 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance: 4 month | 51.4 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance: 8 month | 51.1 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance: 12 month | 51.1 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Intensity: 4 month | 3 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Intensity: 8 month | 2 score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Intensity: 12 month | 3 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Intensity: 8 month | 2 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical Function: 4 month | 41.8 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Ability to Participate: 12 month | 51.7 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical Function: 8 month | 42.1 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance: 4 month | 51.1 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical Function: 12 month | 41.7 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Fatigue: 4 month | 53.1 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression and Sadness: 4 month | 41.0 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Intensity: 4 month | 2 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression and Sadness: 8 month | 41.0 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Fatigue: 8 month | 51.0 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression and Sadness: 12 month | 41.0 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety and Fear: 8 month | 47.9 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance: 8 month | 51.0 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference: 4 month | 54.85 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Fatigue: 12 month | 51.3 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference: 8 month | 54.4 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Intensity: 12 month | 3 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference: 12 month | 53.9 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety and Fear: 4 month | 48.8 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Ability to Participate: 4 month | 48.3 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance: 12 month | 51.7 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety and Fear: 12 month | 47.9 score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Ability to Participate: 8 month | 51.8 score on a scale |