Kenyon 2019.
Study name | |
Methods |
Design: double‐blinded, parallel, randomised controlled trial Duration: endpoint at 3 weeks Setting: recruiting from the Childrens Hospital of Philadelphia; trial conducted in the United States Details of run‐in period: run‐in period to determine eligibility and collect baseline adherence data |
Participants |
Population: 125 participants will be randomised to intervention arm 1, 2, or the control arm Asthma severity: severe Inclusion criteria: 5 to 12 years with permission from parent or legal guardian if required. Caregivers with smartphone. Participants prescribed daily ICS or ICS + LABA. Minimum of 2 hospitalisations OR 1 hospitalisation + 1 emergency department visit in previous year. Exclusion criteria: controller inhaler not suitable for monitoring device. Smartphone with compatibility for trial‐specific application. Children with significant developmental delays or disability, chronic co‐morbidities with potential to impact asthma management. Families with Department of Human Services Involvement. Non‐English speaking. Parents or guardians with medical recommendation not to participate in trial. Allowed medication: none recorded Disallowed medication: none recorded |
Interventions |
Intervention arm 1: daily automated text message reminders or push notification reminders to use ICS and fixed‐ratio monetary incentives for each inhaled dose. Every 7 days an automated feedback summary is delivered to the participant by an electronic mobile platform. 90 intervention sessions (1 reminder daily for 90 days). Two‐way interactivity with patient. No co‐interventions. Intervention arm 2: daily automated text message reminders or push notification reminders to use ICS. Every 7 days an automated feedback summary is delivered to the participant by an electronic mobile platform. 90 intervention sessions (1 reminder daily for 90 days). Two‐way interactivity with patient. Arm 3: Control: no text message or push notification reminders to use ICS |
Outcomes | ICS medication adherence, adherence patterns, asthma control, asthma specific hospitalisations or emergency department visits and associated costs |
Starting date | 1 September 2019 |
Contact information | Chen Kenyon, MD Children's Hospital of Philadelphia |
Notes |
Type of publication: clinicaltrials.gov registry record only NCT03907410 Funding: Childrens Hospital of Philadelphia, National Institute of Health, National Heart, Lung, and Blood Institute |