Telehealth Enhanced Asthma Management

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: Asthma Subspecialty Follow-up Visits

• Registration Number: NCT03414177
• Lead Sponsor: Arkansas Children's Hospital Research Institute

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).

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Study Start: 2018-03-06
• Primary Completion: 2019-08-08
• Study Completion: 2019-10-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-Person Group	Asthma Subspecialty Follow-up Visits	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.
Telemedicine Group	Asthma Subspecialty Follow-up Visits	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Airway Inflammation 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.
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
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.
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

Trial Locations

Locations (1)

Arkansas Children's Hospital Research Institute; 🇺🇸 Little Rock, Arkansas, United States