Telehealth Enhanced Asthma Management

Arkansas Children's Hospital Research Institute15 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

Asthma Subspecialty Follow-up VisitsOTHER

Pediatric patients with persistent asthma will be recruited to compare outcomes among patients with follow-up visits managed via telemedicine vs. in-person visits.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

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.

Time frame: At baseline and 12 months

Secondary Outcomes

Routine Follow up Asthma Visit

Physical examination to assess current asthma problems, symptoms, medication and the child's overall health.

Time frame: At baseline, 4 months, 8 months, 12 months

Lung Function via Spirometry

Spirometry

Time frame: Baseline and 12 months

Airway Inflammation via Spirometry

Spirometry

Time frame: 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.

Time frame: 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.

Time frame: At baseline, 4 months, 8 months, 12 months

Rescue Medication Use

Assessment of rescue medication use by caregiver report.

Time frame: At baseline, 4 months, 8 months, 12 months

Data from ClinicalTrials.gov

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