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Clinical Trials/NCT03414177
NCT03414177
Completed
Not Applicable

Telehealth Enhanced Asthma Management

Arkansas Children's Hospital Research Institute1 site in 1 country15 target enrollmentMarch 6, 2018
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Arkansas Children's Hospital Research Institute
Enrollment
15
Locations
1
Primary Endpoint
Mean difference in ACT score at the final assessment (12 months) after adjusting for baseline
Status
Completed
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 6, 2018
End Date
October 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mean difference in ACT score at the final assessment (12 months) after adjusting for baseline

Time Frame: 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 Outcomes

  • Airway Inflammation via Spirometry(Baseline and 12 months)
  • Healthcare Utilization(At baseline, 4 months, 8 months, 12 months)
  • Routine Follow up Asthma Visit(At baseline, 4 months, 8 months, 12 months)
  • Lung Function via Spirometry(Baseline and 12 months)
  • Medication Adherence(At baseline, 4 months, 8 months, 12 months)
  • Rescue Medication Use(At baseline, 4 months, 8 months, 12 months)
  • Clinic Visit Attendance Rate(At baseline, 4 months, 8 months, 12 months)
  • Visit Satisfaction(At baseline, 4 months, 8 months, 12 months)

Study Sites (1)

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