Medication Self-Adjustment for Atrial Fibrillation

Overseen By Felix Alejandro Ayala Paredes, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Must be taking: Rate control

Disqualifiers: Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it seems you will continue taking your rate control medication and adjust it gradually with guidance.

What data supports the effectiveness of the treatment Self-adjustment of medication for Atrial Fibrillation?

Research shows that using technology, like smartphone apps, can help patients with atrial fibrillation manage their symptoms and medication better, which can improve their health outcomes. Additionally, individualized education on self-management has been shown to improve patients' knowledge and ability to manage their condition. ^{1 2 3 4 5}

Is medication self-adjustment for atrial fibrillation safe for humans?

The research does not provide specific safety data on medication self-adjustment for atrial fibrillation, but highlights the importance of adherence to prescribed treatments to prevent complications like strokes. ^{1 4 6 7 8}

How does the self-adjustment treatment for atrial fibrillation differ from other treatments?

The self-adjustment treatment for atrial fibrillation is unique because it empowers patients to actively manage their medication and symptoms using technology, such as a smartphone app, which can improve adherence and outcomes compared to traditional treatments that require regular monitoring and adjustments by healthcare providers. ^{1 5 9 10 11}

What is the purpose of this trial?

Patients with permanent or persistent atrial fibrillation require rate control medication to prevent excessive tachycardia. Since too much medication leads to a lower than expected heart rate (low output and symptoms) and too little leads to a fast heart rate (with associated symptoms), finding the ideal medication level (target that could fluctuate) is vital for patient's wellbeing. Clinicians adjust the medication each time patients come into the clinic (once or twice a year). In between those visits, medication is not changed even though patients would benefit for some incremental medication adjustment. Patients implanted with Biotronik devices have access to Home Monitoring® (HM), a user friendly remote monitoring system transmitting daily device and patient information to clinicians. Heart rate and activity hours can be tracked and this information could be used to adjust medication. In a step by step process, patients will gradually gain autonomy in the weekly adjustment of their rate control medication. In order to guide medication adjustment by patients, the research team will filter and simplify the information received by HM before sending it to patients. It is hypothesize that patient empowerment, understanding the dynamics of their heart rates in relation to the amount of medication used, will lead to better heart rate control, and it will improve the daily hours of patients activity.

Research Team

Felix Alejandro Ayala Paredes, MD PhD

Principal Investigator

Sherbrooke university medical school

Eligibility Criteria

This trial is for patients with permanent or persistent atrial fibrillation who have a Biotronik pacemaker and use the Home Monitoring system. They should be on stable rate control medication for at least six months. Those with heart failure requiring maximum beta blocker doses, or other conditions preventing medication changes cannot join.

Inclusion Criteria

You have a specific type of pacemaker made by Biotronik that is connected to a HM system.

I have had atrial fibrillation for over 6 months and am on stable medication.

Exclusion Criteria

I cannot change my current medications due to other health issues.

I need the highest dose of beta blocker for my heart failure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment and Monitoring

Participants receive weekly simplified information from the HM system, and physicians adjust rate control medication based on heart rate and activity data.

12 weeks

Weekly remote monitoring

Self-adjustment Phase

Participants self-adjust their rate control medication based on the information received from the HM system.

9 months

Weekly remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Self-adjustment of medication

Trial Overview The study tests if patients can self-adjust their heart rate control medications using data from their pacemakers transmitted via Home Monitoring. The goal is to see if this leads to better heart rate management and improves daily activity by empowering patients.

Participant Groups

Group I: Participants in gradual self-adjustment rate control medication Experimental Treatment 1 Intervention

Patients receive a weekly simplified version of the information transmitted by the HM system. In the first 3 months, using that information, the physician changes or not the rate control medication posology (i.e. if the mean heart rate is 60bpm, betablocker dose is cut to half, and another heart rate evaluation is done a week later, and if heart rate is now 120bpm the dose is increased to a 3/4 of the initial dose, and so on). After those three initial months where physician guide titration, the patient is allowed to make self-adjustment of their medication accordingly to the information received (i.e. increasing or decreasing their rate control medication depending on heart rates and activity hours per day.

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Findings from Research

A review of 555 atrial fibrillation self-management apps found only five that met the criteria for inclusion, indicating a significant lack of high-quality options for patients.

The included apps generally offered basic functions like educational content and medication tracking but were rated as poor to acceptable in quality, lacked intuitive design, and none had undergone clinical trials, highlighting the urgent need for better, clinically validated mHealth interventions for atrial fibrillation management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atrial fibrillation self-management: a mobile telephone app scoping review and content analysis. Pearsons, A., Hanson, CL., Gallagher, R., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Patient Perspectives on Performance of a Smartphone App for Atrial FibrillationSelf-Management. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Prognosis and guideline-adherent antithrombotic treatment in patients with atrial fibrillation and atrial flutter: implications of undertreatment and overtreatment in real-life clinical practice; the Loire Valley Atrial Fibrillation Project. [2017]

3. Australia pubmed.ncbi.nlm.nih.gov

Individualized education focusing on self-management improved the knowledge and self-management behaviour of elderly people with atrial fibrillation: A randomized controlled trial. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Differences and time trends in drug treatment of atrial fibrillation in men and women and doctors' adherence to warfarin therapy recommendations: a Swedish study of prescribed drugs in primary care in 2002 and 2007. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Adherence to warfarin treatment among patients with atrial fibrillation. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Atrial fibrillation self-management: a mobile telephone app scoping review and content analysis. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Limitations to antiarrhythmic drug use in patients with atrial fibrillation. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

New digital adherence devices could prevent millions of strokes from atrial fibrillation by the end of the next century. [2018]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

Quantitative assessment of adherence to treatment in patients with atrial fibrillation in real clinical practice. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Knowledge and self-management behaviors of patients with recently detected atrial fibrillation. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Benefits of once-daily dosing with non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. [2021]