RESUMO
BACKGROUND: Poor adherence to inhaled corticosteroid medications for children with high-risk asthma is both well documented and poorly understood. It has a disproportionate prevalence and impact on children of minority demographics in urban settings. Financial incentives have been shown to be a compelling method to engage those in a high-risk asthma population, but whether adherence can be maintained by offering financial incentives and how these incentives can be used to sustain high adherence are unknown. OBJECTIVE: The aim of this study is to determine the marginal effects of a financial incentive-based intervention on inhaled corticosteroid adherence, health care system use, and costs. METHODS: Participants include children aged 5 to 12 years who have had either at least two hospitalizations or one hospitalization and one emergency department visit for asthma in the year prior to their enrollment (and their caregivers). Participants are given an electronic inhaler sensor in order to track their medication use over a period of 7 months. After a 1-month period of observation, participants are randomized to 1 of 3 arms for a 3-month period. Participants in arm 1 receive daily text message reminders, feedback, and gain-framed, nominal financial incentives; participants in arm 2 receive daily text message reminders and feedback only, and participants in arm 3 receive no reminders, feedback, or incentives. All participants are subsequently observed for an additional 3-month period with no reminders, feedback, or incentives to assess whether any sustained effects are apparent. RESULTS: Study enrollment began in September 2019 with a target sample size of N=125 children. As of June 2020, 61 children have been enrolled. Data collection is estimated to be completed in June 2022, and analyses will be completed by June 2023. CONCLUSIONS: This study will provide data that will help to determine whether a financial incentive-based mobile health intervention for promoting inhaled corticosteroid use can be effective in patients with high-risk asthma over longer periods. TRIAL REGISTRATION: Clinicaltrial.gov NCT03907410; https://clinicaltrials.gov/ct2/show/NCT03907410. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16711.
RESUMO
BACKGROUND: The use of inhaled corticosteroid (ICS) medications has been shown to improve asthma control and reduce asthma-related morbidity and mortality. Two recent randomized trials demonstrated dramatic improvements in ICS adherence by monitoring adherence with electronic sensors and providing automated reminders to participants to take their ICS medications. Given their lower levels of adherence and higher levels of asthma-related emergency department (ED) visits, hospitalizations, and death, urban minority populations could potentially benefit greatly from these types of interventions. OBJECTIVE: The principal objective of this study will be to evaluate the feasibility, acceptability, and limited efficacy of a text message (short message service, SMS) reminder intervention to enhance ICS adherence in an urban minority population of children with asthma. We will also assess trajectories of ICS adherence in the 2 months following asthma hospitalization. METHODS: Participants will include 40 children aged 2-13 years, who are currently admitted to the Children's Hospital of Philadelphia (CHOP) for asthma, and their parent or legal guardian. Participants will be assigned to intervention and control arms using a 1:1 randomization scheme. The intervention arm will receive daily text message reminders for a 30-day intervention phase following hospitalization. This will be followed by a 30-day follow-up phase, in which all participants may choose whether or not to receive the text messages. Feasibility will be assessed by measuring (1) retention of the participants through the study phases and (2) perceived usefulness, acceptability, and preferences regarding the intervention components. Limited efficacy outcomes will include percent adherence to prescribed ICS regimen measured using Propeller Health sensors and change in parent-reported asthma control. We will perform an exploratory analysis to assess for discrete trajectories of adherence using group-based trajectory modeling (GBTM). RESULTS: Study enrollment began in December 2015 and the intervention and follow-up phases are ongoing. Results of the data analysis are expected to be available by December 2016. CONCLUSIONS: This study will add to the literature by providing foundational feasibility data on which elements of a mobile health text-message reminder intervention may need to be modified to suit the needs and constraints of high-risk urban minority populations. TRIAL REGISTRATION: Clinicaltrials.gov NCT02615743; https://www.clinicaltrials.gov/ct2/show/study/NCT02615743 (Archived with WebCite at http://www.webcitation.org/6ji59rAXN).
RESUMO
BACKGROUND: Inner-city, minority children with asthma have the highest rates of morbidity and death from asthma and the lowest rates of asthma controller medication adherence. Some recent electronic medication monitoring interventions demonstrated dramatic improvements in adherence in lower-risk populations. The feasibility and acceptability of such an intervention in the highest-risk children with asthma has not been studied. OBJECTIVE: Our objective was to assess the feasibility and acceptability of a community health worker-delivered electronic adherence monitoring intervention among the highest utilizers of acute asthma care in an inner-city practice. METHODS: This was a prospective cohort pilot study targeting children with the highest frequency of asthma-related emergency department and hospital care within a local managed care Medicaid plan. The 3-month intervention included motivational interviewing, electronic monitoring of controller and rescue inhaler use, and outreach by a community health worker for predefined medication alerts. We measured acceptability by using a modified technology acceptability model and changes in asthma control using the Asthma Control Test (ACT). Given prominent feasibility issues, we describe qualitative patterns of medication use at baseline only. RESULTS: We enrolled 14 non-Hispanic black children with a median age of 3.5 years. Participants averaged 7.8 emergency or hospital visits in the year preceding enrollment. We observed three distinct patterns of baseline controller use: 4 patients demonstrated sustained use, 5 patients had periodic use, and 5 patients lapsed within 2 weeks. All participants initiated use of the electronic devices; however, no modem signal was transmitted for 5 or the 14 participants after a mean of 45 days. Of the 9 (64% of total) caregivers who completed the final study visit, all viewed the electronic monitoring device favorably and would recommend it to friends, and 5 (56%) believed that the device helped to improve asthma control. ACT scores improved by a mean of 2.7 points (P=.05) over the 3-month intervention. CONCLUSIONS: High-utilizer, minority families who completed a community health worker-delivered electronic adherence intervention found it generally acceptable. Prominent feasibility concerns, however, such as recruitment, data transmission failure, and lost devices, should be carefully considered when designing interventions in this setting.