A mobile relational agent to enhance atrial fibrillation self-care: Primary and secondary outcomes of a randomized controlled trial.

BACKGROUND

Atrial fibrillation (AF) requires long-term adherence to oral anticoagulation and self-care.

METHODS

We conducted a randomized controlled trial of a smartphone-based relational agent and heart rhythm monitor with the primary outcome of anticoagulation adherence and secondary outcomes of quality of life (QOL) and health care utilization. The trial enrolled individuals with Atrial fibrillation (AF) taking anticoagulation. Intervention participants received a smartphone-based relational agent for disease education, adherence monitoring, and self-care, and a heart rate and rhythm monitor. Attention control participants received a smartphone health education application and the same heart monitor. Participants had baseline and 4-, 8-, and 12-month visits. The primary outcome was 12-month proportion of days covered (PDC) ascertained with pharmacy claims.

RESULTS

From January, 2020 to April, 2022, the trial enrolled 243 participants (age 70.8 ± 9.8 years; 64.2% female; 30.5% Black race). The adjusted mean PDC at 12 months in the intervention arm was 0.88 (95% Confidence Interval [CI], 0.84-0.93) and in the attention control 0.85 (95% CI, 0.81-0.90) with no difference in odds of PDC ≥ 0.80 in intervention compared to the control (Odds Ratio, 1.26 [95% CI, 0.66-2.38]). Self-reported nonadherence and QOL did not differ by study arm. The event rates for health care utilization were significantly less for intervention than attention control participants as measured by emergency room visits and hospitalizations (P < .001) and number of days hospitalized (P = .004).

CONCLUSION

The smartphone-based relational agent intervention did not achieve its primary endpoint of increased anticoagulation adherence but did yield decreased health care utilization.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04075994.