Telehealth Enhanced Asthma Management (TEAM)

• ClinicalTrials.gov Identifier: NCT03414177
• Recruitment Status: Completed
• First Posted: January 29, 2018
• Last Update Posted: October 8, 2020
• Sponsor: Arkansas Children's Hospital Research Institute
• Information provided by (Responsible Party): Arkansas Children's Hospital Research Institute

Study Description

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.

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 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
• Actual Primary Completion Date: August 8, 2019
• Actual Study Completion Date: October 1, 2019

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Arkansas

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, United States, 72202

Sponsors and Collaborators

Arkansas Children's Hospital Research Institute

Investigators

• Principal Investigator: Tamara T. Perry, MD; Arkansas Children's Research Institute

More Information

• Responsible Party: Arkansas Children's Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT03414177
• Other Study ID Numbers: 207015
• First Posted: January 29, 2018
• Last Update Posted: October 8, 2020
• Last Verified: October 2020

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