Design, methods, and baseline characteristics of a pilot, randomized, controlled trial of the effects of an electronic monitoring device on medication adherence in children with asthma

• DOI: 10.1016/j.conctc.2021.100706
• Publication Date: 2021-02-07T07:36:00Z
• Authors: Jessica P. Hollen...; Tregony Simoneau; Ye Sun; Iris Becene; Sigrid Almeida; Christine Langton; Glenn Flores
• Keywords: Medicine (General); 03 medical and health sciences; R5-920; 0302 clinical medicine; Electronic monitoring device; Adherence; Mobile health; 16. Peace & justice; Children; Asthma; Article; 3. Good health

Current methods of assessing adherence are inaccurate. Electronic monitoring devices (EMDs) may more accurately assess adherence, but not currently used in practice. The design, methods, and participant baseline characteristics described for a pilot trial the effects an EMD on asthma medication pediatric population.This was pilot, randomized, controlled children with persistent managed daily inhaled corticosteroids (ICS). Seventy-five were randomized 2:1 to receive either two EMDs (one ICS one rescue) linked via Bluetooth mobile application (app) or standard care (controls). recorded dates times inhaler actuations app sent reminders participants. Controls provided care. Medication measured using pharmacy refill records self-report, whereas data measure intervention group. Secondary outcomes included control, pulmonary function, quality life.One hundred sixty screened eligibility, 123 individuals excluded. enrolled, 25 allocated control group 50 intervention. mean age participants is 12 years old (±2.9), equal proportions male female children; 45% Latinx 19% African-American; 77% report Medicaid CHIP coverage. Half have moderate 48% had marginally at time enrollment. There no significant inter-group differences sociodemographic characteristics.This successfully reached target populations met recruitment enrollment goals. It addressing important knowledge gap by evaluating rates, findings which could prove useful determining whether routine use clinical practice help achieve better outcomes.NCT03734861.