Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Location status: Recruiting
NCT Number: NCT06820593
A randomized controlled trial with parent-child pairs of children with persistent or uncontrolled asthma. An intervention group (n=40 parent-child pairs) will receive the mobile health (mHealth) app and digital sensors with enhanced support from a population health manager role, hereinafter referred to as an asthma coordinator, to provide remote patient monitoring (RPM). A comparison group (n=40 parent-child pairs) will receive the mHealth app and sensors without RPM support to silently collect inhaler use information without mHealth app features. The focus of this project is to evaluate the feasibility and acceptability of delivering a digital intervention for pediatric asthma with RPM in the outpatient setting.
Interested in participating?
Request Info4 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60611, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion into the study will not depend on sex, ethnicity, or race. We will monitor enrollment to ensure a diversity of sex and race/ethnicity are represented.
PARENT-CHILD PAIR INCLUSION CRITERIA
PARENT-CHILD PAIR EXCLUSION CRITERIA
a. With this trial, the intent is to first establish feasibility and broaden to different languages in future.
HEALTH CARE PROVIDER INCLUSION CRITERIA (IMPLEMENTATION OUTCOMES)
HEALTH CARE PROVIDER EXCLUSION CRITERIA (IMPLEMENTATION OUTCOMES)
The intervention consists of two main components-the mHealth app and sensors that is part of the Adherium's Hailie® Solution-and the remote patient monitoring (RPM), conducted in this intervention by an asthma coordinator.
Participants in the comparison group will receive the sensors for their ICS inhalers and a limited version of the app that only collects the sensor information by Bluetooth, without app features, and sends the information to the Hailie web portal. This passive adherence data collection will allow for comparison of the two groups' adherence rates without the mHealth app self-management support or RPM.
Time frame: Baseline, 12 months
Measured as the number and percentage of participants who complete the 12-month visit, between intervention and comparison group.
Time frame: 12 months
Measured as the number and percentage of participants who synced their ICS sensor >80% of enrolled days in the trial, comparing intervention and comparison groups.
Time frame: Baseline, 1, 3, 6, 9, and 12 months.
Investigators will use the validated childhood Asthma Control Test (c-ACT) for assessing asthma symptom control, or Asthma Control Test (ACT) if the child becomes 12 years old during the study.
Time frame: Continuously through the 12 months
Investigators will compare overall raw ICS adherence rates between intervention and comparison groups using two-sample tests for proportions of mean daily proportion of taken doses over prescribed doses of ICS by study month, measured by digital sensors on the ICS. Participants' data will be included if they had at least 1 ICS inhaler actuation during the trial.
Contact information is provided by the study sponsor or research team.
Ann & Robert H Lurie Children's Hospital of Chicago
Other
Technology-Enhanced Asthma Care in Children at Clinic and Home (TEACCCH) Study (Aim 2): A Feasibility Randomized Controlled Trial
Acronym: TEACCCH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07232550
Asthma, Asthma in Children
Warsaw, Poland
View Trial DetailsNCT06201494
Asthma, Asthma in Children
Prague, Czechia
View Trial DetailsNCT05004714
Asthma in Children, Implementation
District Heights, Maryland, United States
View Trial DetailsNCT06159127
Asthma, Asthma in Children
Cincinnati, Ohio, United States
View Trial Details