Telehealth Enhanced Asthma Management

Study Overview
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Brief Summary
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This study will conduct a 12-month randomized trial with 48 pediatric patients (aged 6-18 years) with persistent asthma to compare outcomes among patients with follow-up visits managed via telemedicine (TM) vs. in-person (IP) visits.

Detailed Description
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The overarching hypothesis is that utilization of TM for asthma follow-up will result in improved clinical outcomes such as Asthma Control Test (ACT) scores, lung function and medication adherence compared to participants receiving IP follow-up care. The Investigator also hypothesize that TM follow-up will result in higher caregiver satisfaction because families will be able to receive quality subspecialty care in their community (TM) compared to those who travel a distance to receive care (IP).

Official Title
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Telehealth Enhanced Asthma Management

Conditions
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Asthma

Intervention / Treatment
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* Other: Asthma Subspecialty Follow-up Visits


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥6- and ≤18 years persistent asthma as defined by national guidelines standards receives care at an ACH asthma subspecialty clinic reside ≤1.5 hour drive from Jonesboro, Springdale, Texarkana, or Fort Smith, AR Exclusion Criteria: Significant underlying respiratory disease other than asthma, such as cystic fibrosis significant co-morbid conditions, such as individuals with developmental or physical impairments that could interfere with the ability to communicate via interactive video current smoker severe asthma exacerbation requiring intubation in the past 12 months no access to a smartphone or internet

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group will receive asthma follow up care via telemedicine at a remote clinical sites. The second group will receive in-person asthma follow-up care at a specialty clinic.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telemedicine Group<br>Telemedicine participants will have asthma subspecialty follow-up visits conducted via real-time audio and video conferencing in conjunction with electronic examination peripherals and remote pulmonary function testing (PFT). Participants will receive a survey link to complete an electronic survey to assess Asthma Control Test (ACT) score, healthcare utilization, and satisfaction. | Other: Asthma Subspecialty Follow-up Visits<br>* Pediatric patients with persistent asthma will be recruited to compare outcomes among patients with follow-up visits managed via telemedicine vs. in-person visits.<br>|
| Active Comparator: In-Person Group<br>In-Person participants will have asthma subspecialty follow-up visits at a subspecialty clinic. They will receive pulmonary function testing (PFT). Participants will receive a survey link to complete an electronic survey to assess Asthma Control Test (ACT) score, healthcare utilization, and satisfaction. | Other: Asthma Subspecialty Follow-up Visits<br>* Pediatric patients with persistent asthma will be recruited to compare outcomes among patients with follow-up visits managed via telemedicine vs. in-person visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in ACT score at the final assessment (12 months) after adjusting for baseline | ACT is used for symptoms monitoring as per guidelines and has been identified as an appropriate asthma control composite score in clinical research. | At baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Routine Follow up Asthma Visit | Physical examination to assess current asthma problems, symptoms, medication and the child's overall health. | At baseline, 4 months, 8 months, 12 months | 
| Lung Function via Spirometry | Spirometry | Baseline and 12 months | 
| Airway Inflammation via Spirometry | Spirometry | Baseline and 12 months | 
| Healthcare Utilization | Patient report of the number of acute exacerbation in the past 12 months resulting in hospitalizations, emergency room or sick visits or steroid use. | At baseline, 4 months, 8 months, 12 months | 
| Medication Adherence | Adherence will be defined as receiving ≥3 controller medication refills/6 months or achieving an Asthma Medication Ratio (AMR) of ≥0.5 based on national asthma guidelines. | At baseline, 4 months, 8 months, 12 months | 
| Rescue Medication Use | Assessment of rescue medication use by caregiver report. | At baseline, 4 months, 8 months, 12 months | 
| Clinic Visit Attendance Rate | Participant clinic attendance / Completion rate for Telemedicine and In-Person group. | At baseline, 4 months, 8 months, 12 months | 
| Visit Satisfaction | Participant report of satisfaction with asthma follow up visit | At baseline, 4 months, 8 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Clinical follow up visits