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| Name | Class |
|---|---|
| Pharmaceutical Research & Manufacturers Of America Foundation | UNKNOWN |
| Apple Inc. | INDUSTRY |
| Itamar-Medical, Israel | INDUSTRY |
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The overall objective of this proposal is to evaluate the effect on quality of life of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life.
Researchers plan to evaluate the effectiveness of this novel digital toolkit in improving quality of life and decreasing AFib burden in a randomized clinical trial (RCT). A pilot study assessing feasibility and retention of the intervention was previously conducted (NCT05400837)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Experimental | Multicomponent virtual atrial fibrillation management program |
|
| Usual Care | No Intervention | Receives usual care. Usual care is defined as care according to the patients care team's standard practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Combination Product | Intervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Freedom from documented atrial tachyarrhythmia | Freedom from documented atrial tachyarrhythmia (atrial fibrillation/atrial flutter/atrial tachycardia) episodes of ≥30 seconds between 91 and 365 days after catheter ablation, on or off antiarrhythmic drugs. | 91 to 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT) | Quality of Life, measured by validated Atrial Fibrillation Effect on Quality of Life (AFEQT) score. Score ranges from 0 to 100 with higher scores signifying better quality of life | 365 days |
| AFib burden (percentage of time) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nino Isakadze | Contact | 410-955-5999 | nisakad1@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nino Isakadze, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Recruiting | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Atrial fibrillation burden (expressed as a percentage of time in atrial fibrillation) between 91 days and 365 days after catheter ablation |
| 91 to 365 days |
| Participants Freedom from atrial tachyarrhythmia off medication | Freedom from atrial tachyarrhythmia episodes ≥30 seconds in duration between 91 days and 365 days after catheter ablation off medications. | 91 to 365 days |
| Participants Freedom from atrial tachyarrhythmia on or off medications | Freedom from atrial tachyarrhythmia episodes ≥30 seconds in duration between day 1 and day 365 after catheter ablation, on and off medications. | 1 day to 365 days |
| Incidence of hospitalizations, emergency room visits, deaths | Safety (composite of hospitalizations, emergency room visits, deaths) | 1 to 365 days |
| Johns Hopkins Outpatient Center | Recruiting | Baltimore | Maryland | 21287 | United States |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |