Atrial Fibrillation Clinical Trial
— AFibLITTOfficial title:
A Mobile Relational Agent to Enhance Atrial Fibrillation Self-care
Verified date | November 2023 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 243 |
Est. completion date | August 1, 2023 |
Est. primary completion date | April 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: 1. Adult, age =21; 2. Diagnosis of AF, identified from the 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. CHA2DS2-VASc (heart failure, hypertension, age, diabetes, prior stroke/TIA, CD, female sex)=2; 4. Prescribed use of warfarin or DOAC (formerly NOAC) 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 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | Boston University, National Heart, Lung, and Blood Institute (NHLBI), Northeastern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Days Covered | Proportion of Days Covered (PDC) is obtained from electronic prescription and pharmacy fill data for oral anticoagulation. PDC is calculated as a percentage (0 to 100%) accounting for days of prescription and date of fill. PDC quantification accounts for days of hospitalization, switching to an alternative anticoagulant agent, and prescribing changes during 12-month follow-up. | 12 months | |
Secondary | Self-reported adherence | A three-item instrument to ascertain self-reported non-adherence. Items are scored with a Likert scale from 0 ("None fo the time.") to 5 ("Every time."). The score is scaled as a continuous measure (0 to 15) and dichotomous categorization. | Baseline, 4, 8 and 12 months | |
Secondary | Change from baseline Atrial Fibrillation Effect on QualiTy of life (AFEQT) at 4, 8 and 12 months | The 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. The AFEQT measure consists of a global score and 4 domains (symptoms, daily activities, treatment concerns, and treatment satisfaction). We prioritize the global score because of its specificity to AF, our experience with this measure in our preliminary and pilot studies, extensive validation, and ease of administration. The AFEQT subdomains (symptoms, daily activities, treatment concerns, and treatment satisfaction) constitute secondary outcomes. | Baseline, 4, 8 and 12 months | |
Secondary | Emergency room visits | The number of emergency room visits will be quantified at 4, 8 and 12 months. These data will be used to compare health care utilization between the two study arms. | 4, 8 and 12 months | |
Secondary | Urgent care visits | The number of urgent care visits will be quantified at 4, 8 and 12 months. These data will be used to compare health care utilization between the two study arms. | 4, 8 and 12 months | |
Secondary | Days of hospitalization | The number of days of hospitalization will be quantified at 4, 8 and 12 months. These data will be used to compare health care utilization between the two study arms. | 4, 8 and 12 months |
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