Clinical trial NCT03174093: Mhealth Application for anTicoagulation Care in Atrial Fibrillation
Official title: A Mobile Health Application to Improve Anticoagulation Care in Atrial Fibrillation: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Anticoagulants; Circulating, Hemorrhagic Disorder
Keywords: Mobile Health
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oral anticoagulant adherence
timeFrame: 6 months
measure: Percent time in therapeutic INR (TTR)
timeFrame: 6 months
Secondary outcomes:
measure: Decisional Conflict Scale
timeFrame: After decision about anticoagulant usually 30 minutes after consultation and on study completion (6 months)
Other outcomes:
Locations:
Study officials:
References: