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

A Mobile Health Application to Improve Anticoagulation Care in Atrial Fibrillation: Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Anticoagulants; Circulating, Hemorrhagic Disorder
• Intervention / Treatment: Behavioral: MATCh AFib application

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tiago Luiz L Leiria, MD PhD; Phone Number: (+55) 51 85744494; Email: drleiria@gmail.com
• Study Contact Backup: Name: Laura S Stephan, MD MSc; Phone Number: (+55) 51 32303600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MATCh AFib; 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.	Behavioral: MATCh AFib application; The application comprehends five steps: (1) An educational video about how AF can cause stroke; (2) A calculator of risk scores (CHA2DS2-VASc, HAS-BLED and SAMe-TT2R2); (3) A screen with pictograms to allow better understanding of the scores by patients and to demonstrate how much each anticoagulant can decrease stroke risk or increase bleeding risk; (4) A summary about types of medications available, and (5) An output formulary in which the physician can register patient's contact to continue receiving information about atrial fibrillation and anticoagulation through SMS. Physicians can save patient's history of INR tests and previous doses of anticoagulation prescribed and also use a calculator to adjust the dose.
No Intervention: Standard Care; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral anticoagulant adherence	For patients on Non-vitamin K antagonists oral anticoagulants, a change from baseline in oral anticoagulant adherence at 6 months to achieve a percentage of days covered (PDC) from 50% to 80%.	6 months
Percent time in therapeutic INR (TTR)	For patients on Vitamin-K antagonists, a change from baseline in TTR at 6 months from 50% to 60%. TTR: percent time in therapeutic INR range calculated by Rosendaal method. An INR value of >2.0 was defined as subtherapeutic, and an INR value <3.0 was defined as supratherapeutic.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional Conflict Scale	Personal perception of decisional conflict measured by the Decisional Conflict Scale (DCS) of O'Connor	After decision about anticoagulant usually 30 minutes after consultation and on study completion (6 months)

Collaborators and Investigators

• Sponsor: Instituto de Cardiologia do Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: January 18, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): June 2, 2017
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Mobile Health
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Hematologic Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Hemorrhagic Disorders
• Other Study ID Numbers: 5043/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No