Skip to main content
OpenTrials
Completed

NCT Number: NCT03414177

Telehealth Enhanced Asthma Management

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Routine Follow up Asthma Visit

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

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

  2. Lung Function via Spirometry

    Time frame: Baseline and 12 months

    Spirometry

  3. Airway Inflammation via Spirometry

    Time frame: Baseline and 12 months

    Spirometry

  4. Healthcare Utilization

    Time frame: 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.

  5. Medication Adherence

    Time frame: 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.

  6. Rescue Medication Use

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

    Assessment of rescue medication use by caregiver report.

  7. Clinic Visit Attendance Rate

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

    Participant clinic attendance / Completion rate for Telemedicine and In-Person group.

  8. Visit Satisfaction

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

    Participant report of satisfaction with asthma follow up visit

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Acronym: TEAM

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 29, 2018
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.