Mhealth Application for anTicoagulation Care in Atrial Fibrillation

NCT03174093 | Unknown DMC

• 1 other identifier: 5043/14
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation; Anticoagulants; Circulating, Hemorrhagic Disorder

Keywords

Mobile Health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Decisional Conflict Scale

  After decision about anticoagulant usually 30 minutes after consultation and on study completion (6 months)

Study Arms (2)

MATCh AFib

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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)

Interventions

MATCh AFib application BEHAVIORAL

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.

MATCh AFib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

MeSH Terms

Conditions

Atrial Fibrillation; Hemorrhagic Disorders

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Tiago Luiz L Leiria, MD PhD

CONTACT

(+55) 51 85744494; drleiria@gmail.com

Laura S Stephan, MD MSc

CONTACT

(+55) 51 32303600

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: June 2, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: November 1, 2018
• Last Updated: June 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share