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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Other: Asthma Subspecialty Follow-up Visits Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
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
Official Title: Telehealth Enhanced Asthma Management
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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.
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: 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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414177


Contacts
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

Locations
United States, Arkansas
Arkansas Children's Hospital Research Institute Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Rita C Hudson Brown, BS    501-364-1538 ext 41538    brownritac@uams.edu   
Principal Investigator: Tamara T. Perry, M.D.         
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: Tamara T. Perry, MD Arkansas Children's Research Institute

Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03414177     History of Changes
Other Study ID Numbers: 207015
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arkansas Children's Hospital Research Institute:
Telemedicine
Clinical follow up visits

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases