Mhealth Application for anTicoagulation Care in Atrial Fibrillation (MATCh AFib)

Instituto de Cardiologia do Rio Grande do Sul

Status: Unknown

Conditions: Atrial Fibrillation; Anticoagulants; Circulating, Hemorrhagic Disorder

Treatments: Behavioral: MATCh AFib application

Study type: Interventional

Funder types: Other

Identifiers

NCT03174093

5043/14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults >=18 years
• Diagnostic of atrial fibrillation
• Indication of oral anticoagulation by their physician, based on risk scores
• Ability to speak, hear and understand Portuguese
• Able to receive and read text messages through a cell phone

Exclusion criteria

Physical impairments that prevent completion of the intervention, cognitive impairments that jeopardize informed consent and/or intervention comprehension and not fluent in Portuguese.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

MATCh AFib

Experimental group

Description:

Participants assigned to the intervention group will have the support of the MATCh AFib application during the consultations with their physician and receive individual text messaging targeting knowledge about atrial fibrillation, medication adherence and monitoring during months 1-3.

Treatment:

Behavioral: MATCh AFib application

Standard Care

No Intervention group

Description:

Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment, INR monitoring and consultations with their physician without mHealth support)