Atrial FibrillationMATCh AFibNCT03174093
Mhealth Application for anTicoagulation Care in Atrial Fibrillation
A study testing MATCh AFib application in people with Atrial Fibrillation and Anticoagulants; Circulating, Hemorrhagic Disorder, run by Instituto de Cardiologia do Rio Grande do Sul.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Anticoagulants; Circulating, Hemorrhagic Disorder
- What is being tested?
- MATCh AFib application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Physical impairments that prevent completion of the intervention, cognitive impairments that jeopardize informed consent and/or intervention comprehension and not fluent in Portuguese.
Trial locations and contacts
No sites are listed yet.
Laura S Stephan, MD MSc contact
About this study
Official title: 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.
Read the 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.
- Being tested
- MATCh AFib application
- Keywords
- Mobile Health
- Medical subject headings
- Atrial Fibrillation, Hemorrhagic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MATCh AFib applicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
Decisional Conflict Scale
Personal perception of decisional conflict measured by the Decisional Conflict Scale (DCS) of O'Connor
Measured: After decision about anticoagulant usually 30 minutes after consultation and on study completion (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study startJun 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174093
- Sponsor's protocol ID
- 5043/14
- Acronym
- MATCh AFib
- Status last verified
- Jun 2017
- First submitted
- 18 Jan 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Health Application to Improve Anticoagulation Care in Atrial Fibrillation: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03174093
- Acronym / sponsor ID
- MATCh AFib / 5043/14
- Keywords
- Mobile Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MATCh AFib | Experimental | Behavioral: MATCh AFib applicationParticipants 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. |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Physical impairments that prevent completion of the intervention, cognitive impairments that jeopardize informed consent and/or intervention comprehension and not fluent in Portuguese.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MATCh AFib applicationThe 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. | Behavioural | MATCh AFib |
Primary outcome
Oral anticoagulant adherence
Time frame: 6 months
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%.
Percent time in therapeutic INR (TTR)
Time frame: 6 months
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.
1 secondary outcome
Decisional Conflict Scale
Time frame: After decision about anticoagulant usually 30 minutes after consultation and on study completion (6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura S Stephan, MD MSc contact
Questions about this trial
What is this clinical trial studying?
A study testing MATCh AFib application in people with Atrial Fibrillation and Anticoagulants; Circulating, Hemorrhagic Disorder, run by Instituto de Cardiologia do Rio Grande do Sul.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiago Luiz L Leiria, MD PhD ((+55) 51 85744494, drleiria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral anticoagulant adherence (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.