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| ID | Type | Description | Link |
|---|---|---|---|
| R61HL144669 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Northeastern University | OTHER |
| Boston University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use. |
|
| Usual care arm | Active Comparator | Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relational Agent and heart rate and rhythm monitor | Behavioral | Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4, 8 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jared W Magnani, MD, MSc | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40545207 | Derived | Magnani JW, Lalama CM, Abebe KZ, Ferry D, Rollman BL, Lancet MQ, Kimani E, Olafsson S, Bickmore T, Paasche-Orlow MK. A mobile relational agent to enhance atrial fibrillation self-care: Primary and secondary outcomes of a randomized controlled trial. Am Heart J. 2025 Dec;290:115-128. doi: 10.1016/j.ahj.2025.06.009. Epub 2025 Jun 20. | |
| 36402276 | Derived | Althouse AD, Abebe KZ, Paasche-Orlow MK, Lalama CM, Ferry D, Lancet M, Swabe G, Bickmore T, Magnani JW. Design, rationale, and baseline characteristics of a randomized controlled trial evaluating a mobile relational agent to enhance atrial fibrillation self-care. Contemp Clin Trials. 2023 Jan;124:107015. doi: 10.1016/j.cct.2022.107015. Epub 2022 Nov 17. |
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The study team will share individual participant data that underlie the results reported in the study's central manuscripts after deidentification (text, tables, figures, and appendices).
Such data will be available beginning 9 months and ending 36 months following publication of the main manuscripts resulting from this clinical trial.
Data will be made available to those investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals may be submitted up to 36 months following article publication. Applicants requesting access to the data will be responsible for the minimal administrative costs to provide the data set.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Pharmacy data were not available for 8 intervention and 7 usual care participants. | Posted | Median | Inter-Quartile Range | Proportion of days covered | 12 months |
|
Data collection occurred from date of consent through the participants 12-month visit.
The study team learned of Adverse Events and Serious Adverse Events by participant interviews at the 4-, 8-, and 12-month assessments; direct contact by participants during scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants' providers; or contact with study team initiated by family or other participant surrogates.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart failure | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain-cardiac | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jared Magnani | University of Pittsburgh | (412)383-0611 | magnanij@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2023 | Mar 28, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 30, 2023 | Mar 28, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006339 | Heart Rate |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Usual Care | Behavioral | Use of the WebMD app and heart rate and rhythm monitor daily for 120 days. |
|
| 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. | 4, 8, and 12 months |
| 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. | 4, 8 and 12 months |
| Emergency Room (ER) Visits and Hospitalizations | The number of emergency room visits and hospitalizations quantified at 12 months. | 12 months |
| 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. | 12 months |
| Investigator withdrew |
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Total family income | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Type of medical insurance | Count of Participants | Participants |
|
| Approximate years with Atrial Fibrillation | Median | Inter-Quartile Range | years |
|
| Warfarin or Direct-acting oral anticoagulant | Count of Participants | Participants |
|
| Non-adherence to oral anticoagulation | Self-reported daily adherence to oral anticoagulation dichotomized as adherent or non-adherent. Three-item instrument each scaled 1-5. Individuals reporting 1 for all items classified as adherent; any individual reporting 2 or higher on any item classified as non-adherent. | Count of Participants | Participants |
|
| AF Effect on Quality of Life | AF Effect on Quality-of-Life questionnaire (AFEQT) Overall score and individual domain scores at baseline. Scores for the overall score and each subscale range from 0-100. For the overall score and the domains, 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). | Median | Inter-Quartile Range | units on a scale |
|
| Patient-Reported Outcomes Measurement Information System 29 item instrument (PROMIS-29)-29 | 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. Scores are transformed using a T-score for 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, and better health for the physical function and satisfaction domains. Pain Intensity item is scored 0 (No pain) to 10 (Worst imaginable pain) in the past 7 days. | Median | Inter-Quartile Range | Score on a scale |
|
| Health literacy | The Newest Vital Sign was used to assess health literacy. Scores range from 0 to 6, with limited limited health literacy defined by a score of 0 to 1; possibility of limited literacy by a score of 2 or 3; and adequate health literacy by a sore of 4, 5, or 6. | Count of Participants | Participants |
|
| Brief Health Literacy Screening Instrument | A 4-item, well-validated instrument for health literacy screening with each item scored from 1-5, with higher scores indicating adequate health literacy. Scores from 4-12 suggest limited health literacy; 13-16 moderate health literacy; 17-20 adequate health literacy. | Count of Participants | Participants |
|
| Patient Health Questionnaire-8 | The Patient Health Questionnaire-8 is an 8-item instrument for depression screening. Scores range from 0 to 24 with higher scores indicating greater likelihood of depression. Scores 5-9 indicate likelihood of mild depression; 10-14, moderate depression; 15-19, moderately severe depression; and 20-24, severe depression. | Median | Inter-Quartile Range | units on a scale |
|
| Underwent prior electrophysiologic procedure | History of prior electrophysiologic procedures. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Body Mass Index (BMI) recorded directly from the electronic health record. | Median | Inter-Quartile Range | Weight (kg) / Height^2(m^2) |
|
| General Health | Self-reported general health assessment, range 1-5, with higher scores indicating perception of better general health. | Count of Participants | Participants |
|
| Smoking History | Count of Participants | Participants |
|
| Montreal Cognitive Assessment | Scores for 76 participants in the intervention arm and 75 participants in the usual care arm were not assessed at baseline, survey was added part way through study recruitment. The score for 1 participant in the intervention arm was not assessed due to participant refusing to answer one section of the survey, therefore unable to score the survey. | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| 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). | 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) | Posted | Count of Participants | Participants | 4, 8 and 12 months |
|
|
|
| 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. | 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) | Posted | Median | Inter-Quartile Range | Score on a scale | 4, 8, and 12 months |
|
|
|
| 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. | 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) | Posted | Median | Inter-Quartile Range | score on a scale | 4, 8 and 12 months |
|
|
|
| Secondary | Emergency Room (ER) Visits and Hospitalizations | The number of emergency room visits and hospitalizations quantified at 12 months. | 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) | Posted | Number | ER visits or hospitalization events | 12 months |
|
|
|
| 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. | 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) | Posted | Number | days | 12 months |
|
|
|
| 2 |
| 123 |
| 30 |
| 123 |
| 18 |
| 123 |
| EG001 | 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. | 2 | 120 | 26 | 120 | 26 | 120 |
| Atrial fibrillation | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Chest pain-cardiac | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Aortic valve disease | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Atrial flutter | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Pericarditis | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| COVID-19 | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Death NOS | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Ambulatory dysfunction | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Colonic hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Acute upper GI bleed | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hematochezia | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Intracranial hemorrhage | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Stroke | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Transient ischemic attacks | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Movements involuntary | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
|
| Gun shot wound | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Intracranial hemorrhage | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hematruia | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Suprapubic catheter dislodged | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Renal calculi | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| INR increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Medication side effect | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Non-small cell lung cancer resection | Surgical and medical procedures | CTCAE (5.0) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Atrial flutter | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Elevated blood pressure | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
|
| Bleeding varicose vein | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Impaired mobility | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Right leg pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Shortness of breath | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Viral syndrome | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Transient ischemic attacks | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Bronchial infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Joint infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Floaters | Eye disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D006439 |
| Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| Prefer not to respond |
|
| Non-adherent |
|
| 8 Month |
|
|
| 12 Month |
|
|
| Physical Function: 8 month |
|
|
| Physical Function: 12 month |
|
|
| Anxiety: 4 month |
|
|
| Anxiety: 8 month |
|
|
| Anxiety: 12 month |
|
|
| Depression: 4 month |
|
|
| Depression:8 month |
|
|
| Depression: 12 month |
|
|
| Fatigue: 4 month |
|
|
| Fatigue: 8 month |
|
|
| Fatigue: 12 month |
|
|
| Sleep Disturbance: 4 month |
|
|
| Sleep Disturbance: 8 month |
|
|
| Sleep Disturbance: 12 month |
|
|
| Ability to Participate in Social Roles and Activities: 4 month |
|
|
| Ability to Participate in Social Roles and Activities: 8 month |
|
|
| Ability to Participate in Social Roles and Activities: 12 month |
|
|
| Pain Interference: 4 month |
|
|
| Pain Interference: 8 month |
|
|
| Pain Interference: 12 month |
|
|
| Pain Intensity (Global 07): 4 month |
|
|
| Pain Intensity (Global 07): 8 month |
|
|
| Pain Intensity (Global 07): 12 month |
|
|
| 8 Month |
|
|
| 12 Month |
|
|