Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-04 @ 2:47 AM
Study NCT ID:
NCT03174093
Status:
UNKNOWN
Last Update Posted:
2017-06-02
First Post:
2017-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mhealth Application for anTicoagulation Care in Atrial Fibrillation
Sponsor:
Instituto de Cardiologia do Rio Grande do Sul
Organization:
Study Overview
Official Title:
A Mobile Health Application to Improve Anticoagulation Care in Atrial Fibrillation: Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2017-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MATCh AFib
Brief Summary:
This study will assess the benefits of using a mobile health application designed for shared decision aid in anticoagulation therapy in patients with Atrial Fibrillation (AF). The aim is to improve their treatment adherence and time in therapeutic International Normalized Ratio (INR) range. The results of this study have the potential to lead to a sustainable and resource-efficient strategy for better prevent thromboembolic events in patients with atrial fibrillation.
Detailed Description:
Atrial Fibrillation is a common disease, with important burden on morbidity and mortality and a challenging management. Its incidence and healthcare costs have increased over the decades. One of the most important features of this arrhythmia is its stroke risk, which can be reduced with the use of anticoagulants. Deciding about anticoagulation therapy is complicated due to frequent competing comorbidities and potential harms of the therapy itself. To achieve better outcomes in preventing stroke, it is paramount that decisions about atrial fibrillation treatment be shared between providers and patients.
Mobile health is empowering individuals to assume a more active role in monitoring and managing their chronic conditions and therapeutic regimens. Also, health professionals are being provided with fast and point-of-care information, which can facilitate decision-making.
Therefore, this study will investigate the effects of an mHealth application idealized to aid shared decision and improve anticoagulation care in atrial fibrillation.
Adults with atrial fibrillation will be recruited from anticoagulation outpatient clinics and Basic Health Units and randomized to either (1) an intervention group in which the mHealth application will be used during the consultations or (2) a control group receiving the usual care with anticoagulation.
It is hypothesized that the intervention group will achieve better anticoagulation outcomes.
Mobile health is empowering individuals to assume a more active role in monitoring and managing their chronic conditions and therapeutic regimens. Also, health professionals are being provided with fast and point-of-care information, which can facilitate decision-making.
Therefore, this study will investigate the effects of an mHealth application idealized to aid shared decision and improve anticoagulation care in atrial fibrillation.
Adults with atrial fibrillation will be recruited from anticoagulation outpatient clinics and Basic Health Units and randomized to either (1) an intervention group in which the mHealth application will be used during the consultations or (2) a control group receiving the usual care with anticoagulation.
It is hypothesized that the intervention group will achieve better anticoagulation outcomes.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: