Arrythmia, Cardiac, Atrial Fibrillation, Familial Atrial Fibrillation, Heart Diseases, Pathologic Processes
Conditions
Keywords
Quality of Life (QoL), Adherence, Health Literacy
Brief summary
Atrial fibrillation (AF) is a common, morbid condition with increasing prevalence. Poor health-related quality of life is common in AF. Patients experience debilitating symptoms and challenging adherence to long-term (possibly lifelong) anticoagulation. The increased risks of stroke, heart failure and mortality associated with AF persist even with optimal treatment. Morbidity in AF is further exacerbated by social factors. Limited health literacy carries challenges of learning a specialized terminology and navigating specialized treatments. In multiple cardiovascular diseases, self-care has demonstrated improvement in self-efficacy, health-related quality of life, symptom burden, and health care utilization - essential components of patient success with AF. Selfcare can provide the critical skills to navigate a challenging chronic disease and improve patient-centered outcomes. Delivery of self-care as a mobile health intervention can complement standard care with a longitudinal intervention to improve patient-centered strategies for AF. While self-care interventions for AF have focused foremost on self-monitoring of anticoagulation,self-care has demonstrated its potential to meet the triple aim of improved patient experience, reduced health care utilization, and lower costs.
Detailed description
This is a randomized clinical trial to evaluate the effect of a smartphone-based intervention called a relational agent on health outcomes in people with atrial fibrillation. The study will enroll 240 patients who reside in Pittsburgh-area with this condition and will randomize them to the intervention or control. Intervention participants will receive a smartphone with the agent, which simulates conversation. In addition they will receive an AliveCor Kardia for heart rate and rhythm monitoring, an FDA-approved, widely used instrument that pairs with the smartphone. Control participants will receive a smartphone with WebMD, a brochure published by the American Heart Association that describes AF, and an AliveCor Kardia. 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 quality of life, medical adherence and health care utilization resulting from the intervention.
Interventions
BEHAVIORALRelational Agent and heart rate and rhythm monitor
Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.
BEHAVIORALUsual Care
Use of the WebMD app and heart rate and rhythm monitor 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 problem list and confirmed by 2 or more reports of AF from separate monitoring events at least 2 weeks apart (electrocardiogram, Holter or event monitor); 3. CHA2DS2-VASc (heart failure, hypertension, age, diabetes, prior stroke or transient ischemic attack, coronary heart disease, female sex)≥2; 4. Prescribed use of warfarin or direct-acting oral anticoagulant for AF stroke prevention; 5. English-speaking well enough to participate in informed consent and this study; 6. 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 nodal ablation or foreseen atrioventricular 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, here the period from the date of the baseline to the 12-month examination. PDC range is 0 to 1.00 with higher values indicating greater proportion of days with medication over the 12-month period of study participation as indicated by pharmacy records. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Non-adherence | 4, 8 and 12 months | Self-reported non-adherence to oral anticoagulation with a 3-item instrument with each item scored 1-5 and lower scores indicating adherence. Scores dichotomized to classify participants as adherent (indicated by reporting 1 on all 3 items) or as non-adherent (indicated by reporting ≥ 2 on any of the 3 items). |
| Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | 4, 8, and 12 months | Measure Description: 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. |
| Atrial Fibrillation Effect on Quality of Life (AFEQT) | 4, 8 and 12 months | The Atrial Fibrillation Effect on Quality of life (AFEQT) is a widely used measure of atrial fibrillation-specific health-related quality of life. Scores range from 0 to 100 with higher scores indicating superior health-related quality of life in AF. |
| Emergency Room (ER) Visits and Hospitalizations | 12 months | The number of emergency room visits and hospitalizations quantified at 12 months. |
| Days of Hospitalization | 12 months | The number of days of hospitalization ascertained from extraction of electronic health records through the 12 months of study duration. Total days spent in hospital over 12 months were summarized as a single count for each participant. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use.
Relational Agent and heart rate and rhythm monitor: Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days. | 123 |
| Usual Care Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use.
Usual Care: Use of the WebMD app and heart rate and rhythm monitor daily for 120 days. | 120 |
| Total | 243 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Investigator withdrew | 3 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 9 |
Baseline characteristics
| Characteristic | Intervention | Total | Usual Care |
|---|---|---|---|
| AF Effect on Quality of Life Daily Activities Score | 66.7 units on a scale | 66.7 units on a scale | 65.6 units on a scale |
| AF Effect on Quality of Life Overall Score | 74.1 units on a scale | 74.1 units on a scale | 73.6 units on a scale |
| AF Effect on Quality of Life Satisfaction with how well your current treatment controls your AF | 83.3 units on a scale | 83.3 units on a scale | 83.3 units on a scale |
| AF Effect on Quality of Life Satisfaction with the extent that treatment has relieved your symptoms of AF | 83.3 units on a scale | 83.3 units on a scale | 83.3 units on a scale |
| AF Effect on Quality of Life Symptoms Score | 87.5 units on a scale | 91.7 units on a scale | 91.7 units on a scale |
| AF Effect on Quality of Life Treatment Concerns Score | 83.3 units on a scale | 80.6 units on a scale | 80.6 units on a scale |
| Age, Continuous | 71.9 years | 71.7 years | 71.3 years |
| Approximate years with Atrial Fibrillation | 4 years | 4 years | 4 years |
| Body Mass Index (BMI) | 31.7 Weight (kg) / Height^2(m^2) | 31.2 Weight (kg) / Height^2(m^2) | 29.9 Weight (kg) / Height^2(m^2) |
| Brief Health Literacy Screening Instrument Adequate | 102 Participants | 187 Participants | 85 Participants |
| Brief Health Literacy Screening Instrument Limited | 7 Participants | 15 Participants | 8 Participants |
| Brief Health Literacy Screening Instrument Moderate | 14 Participants | 41 Participants | 27 Participants |
| Education Associate degree | 15 Participants | 30 Participants | 15 Participants |
| Education Bachelor degree | 20 Participants | 37 Participants | 17 Participants |
| Education Graduate/professional school | 29 Participants | 50 Participants | 21 Participants |
| Education High school graduate | 22 Participants | 47 Participants | 25 Participants |
| Education Some college with no degree | 20 Participants | 42 Participants | 22 Participants |
| Education Some high school with no certificate | 3 Participants | 7 Participants | 4 Participants |
| Education Some vocational/trade school with no certificate | 3 Participants | 5 Participants | 2 Participants |
| Education Unknown | 5 Participants | 12 Participants | 7 Participants |
| Education Vocational/trade certificate | 6 Participants | 13 Participants | 7 Participants |
| Employment Status Employed but temporarily laid off | 1 Participants | 2 Participants | 1 Participants |
| Employment Status Homemaker, not working outside the home | 3 Participants | 5 Participants | 2 Participants |
| Employment Status Retired from my usual job and not working | 82 Participants | 159 Participants | 77 Participants |
| Employment Status Retired from my usual job but working for pay | 11 Participants | 20 Participants | 9 Participants |
| Employment Status Sick or on leave for health reasons | 3 Participants | 6 Participants | 3 Participants |
| Employment Status Unemployed, looking for work | 0 Participants | 1 Participants | 1 Participants |
| Employment Status Unemployed, not looking for work | 3 Participants | 11 Participants | 8 Participants |
| Employment Status Working now, full time | 13 Participants | 27 Participants | 14 Participants |
| Employment Status Working now, part time | 7 Participants | 12 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 123 Participants | 240 Participants | 117 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| General Health Excellent | 5 Participants | 9 Participants | 4 Participants |
| General Health Fair | 34 Participants | 63 Participants | 29 Participants |
| General Health Good | 48 Participants | 95 Participants | 47 Participants |
| General Health Poor | 8 Participants | 16 Participants | 8 Participants |
| General Health Very Good | 28 Participants | 60 Participants | 32 Participants |
| Health literacy Adequate health literacy | 73 Participants | 143 Participants | 70 Participants |
| Health literacy High likelihood of limited health literacy | 20 Participants | 40 Participants | 20 Participants |
| Health literacy Possibility of limited health literacy | 30 Participants | 60 Participants | 30 Participants |
| Marital Status Married or living as such | 62 Participants | 121 Participants | 59 Participants |
| Marital Status Never married/never lived as married | 21 Participants | 44 Participants | 23 Participants |
| Marital Status Separated or divorced | 15 Participants | 33 Participants | 18 Participants |
| Marital Status Widowed | 25 Participants | 45 Participants | 20 Participants |
| Montreal Cognitive Assessment Not assessed | 77 Participants | 152 Participants | 75 Participants |
| Montreal Cognitive Assessment Score greater than or equal to 19 | 33 Participants | 70 Participants | 37 Participants |
| Montreal Cognitive Assessment Score less than 19 | 13 Participants | 21 Participants | 8 Participants |
| Non-adherence to oral anticoagulation No | 107 Participants | 210 Participants | 103 Participants |
| Non-adherence to oral anticoagulation Yes | 16 Participants | 33 Participants | 17 Participants |
| Patient Health Questionnaire-8 | 3 units on a scale | 3 units on a scale | 3 units on a scale |
| Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Ability to Participate in Social Roles and Activities (T-score) | 51.9 Score on a scale | 51.9 Score on a scale | 51.9 Score on a scale |
| Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Anxiety (T-score) | 40.3 Score on a scale | 48.0 Score on a scale | 48.0 Score on a scale |
| Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Depression (T-score) | 41.0 Score on a scale | 41.0 Score on a scale | 41.0 Score on a scale |
| Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Fatigue (T-score) | 51.0 Score on a scale | 51.0 Score on a scale | 51.0 Score on a scale |
| Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Pain Intensity (Global07) | 3 Score on a scale | 3 Score on a scale | 3 Score on a scale |
| Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Pain Interference (T-score) | 55.6 Score on a scale | 53.9 Score on a scale | 53.9 Score on a scale |
| Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Physical Function (T-score) | 40.5 Score on a scale | 41.9 Score on a scale | 43.5 Score on a scale |
| Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 Sleep Disturbance (T-score) | 50.5 Score on a scale | 50.5 Score on a scale | 50.5 Score on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants | 74 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 84 Participants | 161 Participants | 77 Participants |
| Sex: Female, Male Female | 87 Participants | 156 Participants | 69 Participants |
| Sex: Female, Male Male | 36 Participants | 87 Participants | 51 Participants |
| Smoking History Currently smoke No | 114 Participants | 221 Participants | 107 Participants |
| Smoking History Currently smoke Prefer not to respond | 1 Participants | 1 Participants | 0 Participants |
| Smoking History Currently smoke Yes | 8 Participants | 21 Participants | 13 Participants |
| Smoking History Ever smoked cigarettes No | 49 Participants | 107 Participants | 58 Participants |
| Smoking History Ever smoked cigarettes Prefer not to respond | 1 Participants | 1 Participants | 0 Participants |
| Smoking History Ever smoked cigarettes Yes | 73 Participants | 135 Participants | 62 Participants |
| Total family income $20,000 to $34,999 | 15 Participants | 35 Participants | 20 Participants |
| Total family income $35,000 to $49,999 | 14 Participants | 32 Participants | 18 Participants |
| Total family income $50,000 to $74,999 | 22 Participants | 39 Participants | 17 Participants |
| Total family income $75,000 to $99,999 | 14 Participants | 27 Participants | 13 Participants |
| Total family income Don't know | 13 Participants | 22 Participants | 9 Participants |
| Total family income Greater than or equal to $100,000 | 16 Participants | 34 Participants | 18 Participants |
| Total family income Less than or equal to $19,999 | 17 Participants | 29 Participants | 12 Participants |
| Total family income Prefer not to respond | 12 Participants | 25 Participants | 13 Participants |
| Type of medical insurance Great than 2 types | 6 Participants | 8 Participants | 2 Participants |
| Type of medical insurance Medicaid | 3 Participants | 4 Participants | 1 Participants |
| Type of medical insurance Medicaid/Medicare | 11 Participants | 19 Participants | 8 Participants |
| Type of medical insurance Medicaid/Private | 2 Participants | 3 Participants | 1 Participants |
| Type of medical insurance Medicaid/Tricare | 1 Participants | 1 Participants | 0 Participants |
| Type of medical insurance Medicare | 13 Participants | 25 Participants | 12 Participants |
| Type of medical insurance Medicare/Other | 1 Participants | 3 Participants | 2 Participants |
| Type of medical insurance Medicare/Private | 52 Participants | 107 Participants | 55 Participants |
| Type of medical insurance Medicare/Tricare | 0 Participants | 1 Participants | 1 Participants |
| Type of medical insurance None | 0 Participants | 1 Participants | 1 Participants |
| Type of medical insurance Other | 0 Participants | 1 Participants | 1 Participants |
| Type of medical insurance Private | 32 Participants | 68 Participants | 36 Participants |
| Type of medical insurance Private/Other | 1 Participants | 1 Participants | 0 Participants |
| Type of medical insurance Tricare/Private | 1 Participants | 1 Participants | 0 Participants |
| Underwent prior electrophysiologic procedure Underwent a defibrillator insertion No | 115 Participants | 225 Participants | 110 Participants |
| Underwent prior electrophysiologic procedure Underwent a defibrillator insertion Yes | 8 Participants | 18 Participants | 10 Participants |
| Underwent prior electrophysiologic procedure Underwent a pacemaker insertion No | 107 Participants | 207 Participants | 100 Participants |
| Underwent prior electrophysiologic procedure Underwent a pacemaker insertion Yes | 16 Participants | 36 Participants | 20 Participants |
| Underwent prior electrophysiologic procedure Underwent a pulmonary vein isolation No | 123 Participants | 243 Participants | 120 Participants |
| Underwent prior electrophysiologic procedure Underwent a pulmonary vein isolation Yes | 0 Participants | 0 Participants | 0 Participants |
| Underwent prior electrophysiologic procedure Underwent electrical cardioversion No | 91 Participants | 172 Participants | 81 Participants |
| Underwent prior electrophysiologic procedure Underwent electrical cardioversion Yes | 32 Participants | 71 Participants | 39 Participants |
| Underwent prior electrophysiologic procedure Underwent medication cardioversion No | 121 Participants | 239 Participants | 118 Participants |
| Underwent prior electrophysiologic procedure Underwent medication cardioversion Yes | 2 Participants | 4 Participants | 2 Participants |
| Warfarin or Direct-acting oral anticoagulant Eliquis (Apixaban) | 73 Participants | 154 Participants | 81 Participants |
| Warfarin or Direct-acting oral anticoagulant Pradaxa (Dabigatran) | 1 Participants | 2 Participants | 1 Participants |
| Warfarin or Direct-acting oral anticoagulant Warfarin (also called Coumadin, Jantoven) | 19 Participants | 34 Participants | 15 Participants |
| Warfarin or Direct-acting oral anticoagulant Xarelto (Rivaroxaban) | 30 Participants | 53 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 123 | 2 / 120 |
| other Total, other adverse events | 18 / 123 | 26 / 120 |
| serious Total, serious adverse events | 30 / 123 | 26 / 120 |
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, here the period from the date of the baseline to the 12-month examination. PDC range is 0 to 1.00 with higher values indicating greater proportion of days with medication over the 12-month period of study participation as indicated by pharmacy records.
Time frame: 12 months
Population: Pharmacy data were not available for 8 intervention and 7 usual care participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Proportion of Days Covered | 1.0 Proportion of days covered |
| Usual Care | Proportion of Days Covered | 0.9 Proportion of days covered |
Comparison: Proportion of days covered assessed as a continuous measure (range 0-1) at 12 months between study arms adjusted for trial stratification factors (type of anticoagulant treatment). We determined that a sample size of 120 in the intervention group and 120 in the control group enables us to detect a minimum difference in PDC as small as 12.6% with 90% power. Power calculations assume use of 2-sided tests with 0.05 significance level.p-value: 0.22t-test, 2 sided
Secondary
Atrial Fibrillation Effect on Quality of Life (AFEQT)
The Atrial Fibrillation Effect on Quality of life (AFEQT) is a widely used measure of atrial fibrillation-specific health-related quality of life. Scores range from 0 to 100 with higher scores indicating superior health-related quality of life in AF.
Time frame: 4, 8 and 12 months
Population: Intervention arm:~4-month: n=111 (11 withdrawals \[w/d\]; 1 missed visit) 8-month: n=109 (total 13 w/d; 1 missed visit) 12-month: n=108 (total 13 w/d; 2 missed visit)~Usual Care:~4-month: n=107 (10 w/d; 3 missed visit) 8-month: n=107 (total 10 w/d; 3 missed visit) 12-month: n=103 (total 12 w/d; 5 missed visit)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | 12 Month | 76.9 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | 4 Month | 77.8 score on a scale |
| Intervention | Atrial Fibrillation Effect on Quality of Life (AFEQT) | 8 Month | 79.6 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | 4 Month | 79.6 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | 8 Month | 77.8 score on a scale |
| Usual Care | Atrial Fibrillation Effect on Quality of Life (AFEQT) | 12 Month | 82.4 score on a scale |
Secondary
Days of Hospitalization
The number of days of hospitalization ascertained from extraction of electronic health records through the 12 months of study duration. Total days spent in hospital over 12 months were summarized as a single count for each participant.
Time frame: 12 months
Population: Intervention:~n=112 (11 withdrawals prior to month-4 visit, date of first collection of this outcome)~Usual care n=110 (10 withdrawals prior to month-4 visit, date of first collection of this outcome)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Days of Hospitalization | 292 days |
| Usual Care | Days of Hospitalization | 638 days |
Secondary
Emergency Room (ER) Visits and Hospitalizations
The number of emergency room visits and hospitalizations quantified at 12 months.
Time frame: 12 months
Population: Intervention:~n=112 (11 withdrawals prior to month-4 visit, date of first collection of this outcome)~Usual care n=110 (10 withdrawals prior to month-4 visit, date of first collection of this outcome)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Emergency Room (ER) Visits and Hospitalizations | 71 ER visits or hospitalization events |
| Usual Care | Emergency Room (ER) Visits and Hospitalizations | 163 ER visits or hospitalization events |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Measure Description: 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: n=111 (11 withdrawals \[w/d\]; 1 missed visit) 8-month: n=109 (total 13 w/d; 1 missed visit) 12-month: n=108 (total 13 w/d; 2 missed visit)~Usual Care:~4-month: n=107 (10 w/d; 3 missed visit) 8-month: n=107 (total 10 w/d; 3 missed visit) 12-month: n=103 (total 12 w/d; 5 missed visit)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression: 4 month | 41.0 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 | 41.9 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety: 4 month | 40.3 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety: 8 month | 40.3 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety: 12 month | 40.3 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical Function: 4 month | 41.9 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression:8 month | 41.0 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression: 12 month | 41.0 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 | 48.6 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance: 4 month | 48.4 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance: 8 month | 48.4 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance: 12 month | 48.4 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Ability to Participate in Social Roles and Activities: 4 month | 51.9 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Ability to Participate in Social Roles and Activities: 8 month | 51.9 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Ability to Participate in Social Roles and Activities: 12 month | 51.0 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference: 4 month | 57.1 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference: 8 month | 55.6 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference: 12 month | 55.6 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Intensity (Global 07): 4 month | 4 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Intensity (Global 07): 8 month | 3 Score on a scale |
| Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Intensity (Global 07): 12 month | 4 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Intensity (Global 07): 8 month | 3 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical Function: 4 month | 41.9 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance: 4 month | 50.5 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical Function: 8 month | 41.9 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference: 4 month | 55.6 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical Function: 12 month | 43.5 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance: 8 month | 50.5 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety: 4 month | 48.0 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Intensity (Global 07): 4 month | 3 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety: 8 month | 48.0 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance: 12 month | 50.5 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety: 12 month | 40.3 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference: 8 month | 55.6 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression: 4 month | 41.0 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Ability to Participate in Social Roles and Activities: 4 month | 51.9 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression:8 month | 41.0 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Intensity (Global 07): 12 month | 3 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression: 12 month | 41.0 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Ability to Participate in Social Roles and Activities: 8 month | 51.9 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 | Pain Interference: 12 month | 55.6 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 | Ability to Participate in Social Roles and Activities: 12 month | 51.9 Score on a scale |
| Usual Care | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Fatigue: 12 month | 48.6 Score on a scale |
Secondary
Self-reported Non-adherence
Self-reported non-adherence to oral anticoagulation with a 3-item instrument with each item scored 1-5 and lower scores indicating adherence. Scores dichotomized to classify participants as adherent (indicated by reporting 1 on all 3 items) or as non-adherent (indicated by reporting ≥ 2 on any of the 3 items).
Time frame: 4, 8 and 12 months
Population: Intervention 4-month: n=111 (11 withdrawals \[w/d\]; 1 missed visit) 8-month: n=109 (total 13 w/d; 1 missed visit) 12-month: n= 108 (total 13 w/d; 2 missed the visit)~Usual care 4-months: n=107 (10 w/d; 3 missed visit) 8 months: n=107 (total 10 w/d; 3 missed visit) 12-months: n=103 (total 12 w/d; 5 missed visit)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | Self-reported Non-adherence | 4 Month | Adherent | 99 Participants |
| Intervention | Self-reported Non-adherence | 4 Month | Non-adherent | 12 Participants |
| Intervention | Self-reported Non-adherence | 8 Month | Adherent | 99 Participants |
| Intervention | Self-reported Non-adherence | 8 Month | Non-adherent | 10 Participants |
| Intervention | Self-reported Non-adherence | 12 Month | Adherent | 94 Participants |
| Intervention | Self-reported Non-adherence | 12 Month | Non-adherent | 14 Participants |
| Usual Care | Self-reported Non-adherence | 12 Month | Adherent | 85 Participants |
| Usual Care | Self-reported Non-adherence | 4 Month | Adherent | 87 Participants |
| Usual Care | Self-reported Non-adherence | 8 Month | Non-adherent | 20 Participants |
| Usual Care | Self-reported Non-adherence | 4 Month | Non-adherent | 20 Participants |
| Usual Care | Self-reported Non-adherence | 12 Month | Non-adherent | 18 Participants |
| Usual Care | Self-reported Non-adherence | 8 Month | Adherent | 87 Participants |