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Telehealth Enhanced Asthma Management (TEAM)

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ClinicalTrials.gov Identifier: NCT03414177
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

January 9, 2018
January 29, 2018
April 10, 2018
March 6, 2018
October 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03414177 on ClinicalTrials.gov Archive Site
  • 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.
  • Lung Function via Spirometry [ Time Frame: Baseline and 12 months ]
    Spirometry
  • Airway Inflammation via Spirometry [ Time Frame: Baseline and 12 months ]
    Spirometry
  • 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.
  • 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.
  • Rescue Medication Use [ Time Frame: At baseline, 4 months, 8 months, 12 months ]
    Assessment of rescue medication use by caregiver report.
  • 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.
  • Visit Satisfaction [ Time Frame: At baseline, 4 months, 8 months, 12 months ]
    Participant report of satisfaction with asthma follow up visit
Same as current
Not Provided
Not Provided
 
Telehealth Enhanced Asthma Management
Telehealth Enhanced Asthma Management
This study will conduct a 12-month randomized trial with 84 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).
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Asthma
Other: Asthma Subspecialty Follow-up Visits
Pediatric patients with persistent asthma will be recruited to compare outcomes among patients with follow-up visits managed via telemedicine vs. in-person visits.
  • Active Comparator: Telemedicine Group
    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.
    Intervention: Other: Asthma Subspecialty Follow-up Visits
  • Active Comparator: In-Person Group
    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.
    Intervention: Other: Asthma Subspecialty Follow-up Visits
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
84
Same as current
January 2020
October 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 18 Years   (Child, Adult)
Yes
Contact: Tamara T. Perry, MD 501-364-1060 ext 1538 perrytamarat@uams.edu
Contact: Rita C. Hudson Brown, BS 501-364-1538 ext 1538 brownritac@uams.edu
United States
 
 
NCT03414177
207015
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Arkansas Children's Hospital Research Institute
Arkansas Children's Hospital Research Institute
Not Provided
Principal Investigator: Tamara T. Perry, MD Arkansas Children's Research Institute
Arkansas Children's Hospital Research Institute
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP