SMART@Home Digital Platform for Asthma Management
Recruiting in Palo Alto (17 mi)
Overseen byKevin Hommel, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Children's Hospital Medical Center, Cincinnati
Disqualifiers: Pervasive developmental disorder, Serious mental illness
No Placebo Group
Trial Summary
What is the purpose of this trial?The proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients. Previous attempts have had poor clinical validity and suffered lack of patient engagement. The study team will deconstruct the previously implemented SMART platforms to create a roadmap, platform, and template to guide clinicians to create new tools.
Results from Phase 1 of this project highlighted the need for connectivity between the SMART@Home app and Bluetooth-enable devices to provide objective disease activity data as well as integration with Epic electronic health record so that providers can use the data to inform treatment planning and decision making. A subsequent pilot user validation trial is also needed to confirm development goals were met. Conducting a pilot user validation trial of the SMART@Home asthma tracker, spirometer, and action plan is the purpose of the next phases of this study.
A beta test the SMART@Home Asthma Tracker and asthma action plan algorithm will take place with approximately 8 participants. Beta testing will have participants record simulated increases in symptoms to ensure appropriate levels of care is communicated via the app. Then, a group of 40 adolescent (ages 12-17) patients with asthma for a 6-month pilot Randomized Control Trial (RCT). Participants will be randomized into either the IMAAP SMART@Home (n=20) or control (n=20) groups following the completion of baseline measures to test the interactive asthma action plan functionality and impact.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing a digital platform for asthma management, so it's likely you can continue your usual treatment, but please confirm with the trial coordinators.
What data supports the effectiveness of the SMART@Home treatment for asthma management?
Research shows that mobile health apps paired with inhaler sensors can help people manage their asthma better. Additionally, using mobile phones for asthma monitoring has been found to improve asthma control compared to traditional methods.
12345Is the SMART@Home Digital Platform for Asthma Management safe for humans?
The safety of asthma treatments has been studied, with some patients reporting tiredness and palpitations as common side effects. However, improving asthma control and patient education may help reduce these adverse effects.
678910How is the SMART@Home Digital Platform for Asthma Management different from other asthma treatments?
The SMART@Home Digital Platform is unique because it integrates digital tools like mobile apps and wearable sensors to help patients manage asthma at home. Unlike traditional treatments that focus on medication, this platform empowers patients with real-time data and self-assessment tools to improve asthma control.
34111213Eligibility Criteria
This trial is for young people aged 11-17 with asthma who need regular treatment. They and their caregivers must speak English fluently. It's not open to those with developmental disorders or serious mental illnesses like schizophrenia, as noted in medical records.Inclusion Criteria
I am between 11 and 17 years old.
English fluency for patient and caregiver
I have a chronic condition like asthma that needs regular treatment.
Exclusion Criteria
Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Beta Testing
Beta test of the SMART@Home Asthma Tracker and asthma action plan algorithm with approximately 8 participants, recording simulated increases in symptoms
4 weeks
Pilot Randomized Control Trial (RCT)
6-month pilot RCT with 40 adolescent patients with asthma, testing the interactive asthma action plan functionality and impact
6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The SMART@Home feasibility trial is testing a digital platform designed to help manage complex patient care remotely. It includes an app that connects to Bluetooth devices for tracking asthma and integrates with the Epic health record system.
2Treatment groups
Experimental Treatment
Active Control
Group I: SMART@HomeExperimental Treatment1 Intervention
Use of the SMART@Home app for medication and symptom tracking, spirometry feedback
Group II: ControlActive Control1 Intervention
Usual Care
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cincinnati Children's Hospital Medical CenterCincinnati, OH
Loading ...
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
References
Systematic Review of mHealth Applications That Interface with Inhaler Sensors in Asthma. [2021]A better understanding of outcomes associated with mobile health (mHealth) applications (apps) for asthma self-management that pair with inhaler sensor technology is needed for clinicians to practice evidence-based medicine.
Assessing the technical feasibility of a flexible, integrated Internet-of-things connected for asthma (C4A) system to support self-management: a mixed method study exploring patients and healthcare professionals perspectives. [2023]A connected system with smart devices could transform patient care and empower patients control of their asthma.
A Wearable IoT Aldehyde Sensor for Pediatric Asthma Research and Management. [2020]A cloud-based wearable IoT aldehyde sensor system for asthma research and management.
A mixed method observational study of strategies to promote adoption and usage of an application to support asthma self-management. [2021]Apps can potentially support asthma self-management, however attracting downloads and encouraging on-going adherence is challenging.
Clinical and cost effectiveness of mobile phone supported self monitoring of asthma: multicentre randomised controlled trial. [2023]To determine whether mobile phone based monitoring improves asthma control compared with standard paper based monitoring strategies.
Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. [2021]As asthma medications are frequently prescribed for children, knowledge of the safety of these drugs in the paediatric population is important. Although spontaneous reports cannot be used to prove causality of adverse events, they are important in the detection of safety signals.
Reporting of the safety from allergic rhinitis trials registered on ClinicalTrials.gov and in publications: An observational study. [2022]Incomplete and inconsistent reporting of adverse events (AEs) through multiple sources can distort impressions of the overall safety of the medical interventions examined as well as the benefit-risk relationship. We aimed to assess completed allergic rhinitis (AR) trials registered in ClinicalTrials.gov for completeness and consistency of AEs reporting comparing ClinicalTrials.gov and corresponding publications.
Patient-reported adverse events under asthma therapy: a community pharmacy-based survey. [2015]The characteristics of patients who report adverse events (AEs) attributed to asthma therapy have been little investigated. Asthma patients aged 18-50 years were surveyed in pharmacies. Patients completed a questionnaire linked to computerized records of dispensed medications. Patients reported all AEs that they attributed to asthma therapy. The correlates of reporting 2+ AEs were identified. Almost 59% of the 1,351 patients (mean age: 37, 56% females) attributed AEs to asthma therapy, and 35% at least two. Most common AEs included tiredness (21.8%) and palpitations (21.1%). Poor asthma control and perception of asthma as a handicap were the major correlates of reporting 2+ AEs (odds ratio (OR)=2.5, 95% confidence interval (CI)=[1.7-3.7] and OR=1.9, 95% CI=[1.4-2.5]). Other significant correlates included age >30 years, female gender, and receiving psychotropic therapy. Inadequate control may partly account for AEs attributed by patients to asthma therapy. Improving patients' education may help to improve acceptability of asthma therapy.
Adverse Drug Events Related to Common Asthma Medications in US Hospitalized Children, 2000-2016. [2022]The reduction in adverse drug events is a priority in healthcare. Medications are frequently prescribed for asthmatic children, but epidemiological trends of adverse drug events related to anti-asthmatic medications have not been described in hospitalized children.
Post-market surveillance of consumer products: Framework for adverse event management. [2022]Analysis of spontaneous reports of adverse events is an important source of information that can be used to improve consumer products. Various agencies have adverse event reporting requirements and many companies collect such data directly from consumers. Nonetheless, a universal framework is absent that identifies and evaluates spontaneously reported adverse events, and, most important, assesses the potential association between exposure and adverse events. We are presenting a three-part framework: Phase I - Intake and Documentation of Original Incidents; Phase II - In Depth Review and Follow-up of Phase I Incidents (enhanced, tailored questionnaire); Phase III - Association Assessment. The basis for scoring the strength of association between exposure and adverse events requires assessment of standard factors of association including: temporality; biological, physiological, or pharmacological plausibility; results of de-challenge; results of re-challenge; and consideration of confounding factors. Scores tied to the answers to these questions are totaled for each incident to determine the strength of association between exposure and reported adverse event. We propose that consumer product companies come together to adopt such an association assessment framework to improve adverse event management, obtain maximum value from the data obtained, and use the knowledge derived to improve overall product safety for consumers.
Development of online diary and self-management system on e-Healthcare for asthmatic children in Taiwan. [2014]Many regional programs of the countries educate asthmatic children and their families to manage healthcare data. This study aims to establish a Web-based self-management system, eAsthmaCare, to promote the electronic healthcare (e-Healthcare) services for the asthmatic children in Taiwan. The platform can perform real time online functionality based upon a five-tier infrastructure with mutually supportive components to acquire asthma diaries, quality of life assessments and health educations.
Integrated Self-Management System for Improved Treatment of Asthma. [2018]A mobile, affordable product that provides clinicians and patients with comprehensive asthma assessment is needed to improve asthma control. Our solution is an integrated system consisting of a portable, inexpensive, easy-to-use spirometer and a mobile application that communicates wirelessly with the spirometer. Results demonstrated that the wireless asthma management solution meets recommended American Thoracic Society (ATS) and European Respiratory Society (ERS) standards. The device is expected to empower patients to accurately self-assess their asthma for better self-management at home, work, or leisure.
Biomedical REAl-Time Health Evaluation (BREATHE): toward an mHealth informatics platform. [2022]To describe a configurable mobile health (mHealth) framework for integration of physiologic and environmental sensors to be used in studies focusing on the domain of pediatric asthma.