Asthma
Conditions
Keywords
Telemedicine, Clinical follow up visits
Brief summary
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
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).
Interventions
OTHERAsthma Subspecialty Follow-up Visits
Pediatric patients with persistent asthma will be recruited to compare outcomes among patients with follow-up visits managed via telemedicine vs. in-person visits.
Sponsors
Arkansas Children's Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. age ≥6- and ≤18 years 2. persistent asthma as defined by national guidelines standards 3. receives care at an ACH asthma subspecialty clinic 4. reside ≤1.5 hour drive from Jonesboro, Springdale, Texarkana, or Fort Smith, AR
Exclusion criteria
1. Significant underlying respiratory disease other than asthma, such as cystic fibrosis 2. significant co-morbid conditions, such as individuals with developmental or physical impairments that could interfere with the ability to communicate via interactive video 3. current smoker 4. severe asthma exacerbation requiring intubation in the past 12 months 5. no access to a smartphone or internet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean difference in ACT score at the final assessment (12 months) after adjusting for baseline | At baseline and 12 months | ACT is used for symptoms monitoring as per guidelines and has been identified as an appropriate asthma control composite score in clinical research. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Routine Follow up Asthma Visit | At baseline, 4 months, 8 months, 12 months | Physical examination to assess current asthma problems, symptoms, medication and the child's overall health. |
| Lung Function via Spirometry | Baseline and 12 months | Spirometry |
| Healthcare Utilization | At baseline, 4 months, 8 months, 12 months | Patient report of the number of acute exacerbation in the past 12 months resulting in hospitalizations, emergency room or sick visits or steroid use. |
| Airway Inflammation via Spirometry | Baseline and 12 months | Spirometry |
| Rescue Medication Use | At baseline, 4 months, 8 months, 12 months | Assessment of rescue medication use by caregiver report. |
| Clinic Visit Attendance Rate | At baseline, 4 months, 8 months, 12 months | Participant clinic attendance / Completion rate for Telemedicine and In-Person group. |
| Visit Satisfaction | At baseline, 4 months, 8 months, 12 months | Participant report of satisfaction with asthma follow up visit |
| Medication Adherence | At baseline, 4 months, 8 months, 12 months | 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. |
Countries
United States
Outcome results
None listed