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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine Group | Active Comparator | 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. |
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| In-Person Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asthma Subspecialty Follow-up Visits | Other | Pediatric patients with persistent asthma will be recruited to compare outcomes among patients with follow-up visits managed via telemedicine vs. in-person visits. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamara T. Perry, MD | Arkansas Children's Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital Research Institute | Little Rock | Arkansas | 72202 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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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.
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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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |