Back to resultsTelehealth Enhanced Asthma Management (TEAM)
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma Subspecialty Follow-up Visits
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Telemedicine, Clinical follow up visits
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
Sites / Locations
- Arkansas Children's Hospital Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Telemedicine Group
In-Person Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Mean difference in ACT score at the final assessment (12 months) after adjusting for baseline
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
Routine Follow up Asthma Visit
Physical examination to assess current asthma problems, symptoms, medication and the child's overall health.
Lung Function via Spirometry
Spirometry
Airway Inflammation via Spirometry
Spirometry
Healthcare Utilization
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
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
Assessment of rescue medication use by caregiver report.
Clinic Visit Attendance Rate
Participant clinic attendance / Completion rate for Telemedicine and In-Person group.
Visit Satisfaction
Participant report of satisfaction with asthma follow up visit
Full Information
NCT ID
NCT03414177
First Posted
January 9, 2018
Last Updated
October 6, 2020
Sponsor
Arkansas Children's Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03414177
Brief Title
Telehealth Enhanced Asthma Management
Acronym
TEAM
Official Title
Telehealth Enhanced Asthma Management
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Children's Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Telemedicine, Clinical follow up visits
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemedicine Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
In-Person Group
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Asthma Subspecialty Follow-up Visits
Intervention Description
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 Measure Information:
Title
Mean difference in ACT score at the final assessment (12 months) after adjusting for baseline
Description
ACT is used for symptoms monitoring as per guidelines and has been identified as an appropriate asthma control composite score in clinical research.
Time Frame
At baseline and 12 months
Secondary Outcome Measure Information:
Title
Routine Follow up Asthma Visit
Description
Physical examination to assess current asthma problems, symptoms, medication and the child's overall health.
Time Frame
At baseline, 4 months, 8 months, 12 months
Title
Lung Function via Spirometry
Description
Spirometry
Time Frame
Baseline and 12 months
Title
Airway Inflammation via Spirometry
Description
Spirometry
Time Frame
Baseline and 12 months
Title
Healthcare Utilization
Description
Patient report of the number of acute exacerbation in the past 12 months resulting in hospitalizations, emergency room or sick visits or steroid use.
Time Frame
At baseline, 4 months, 8 months, 12 months
Title
Medication Adherence
Description
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.
Time Frame
At baseline, 4 months, 8 months, 12 months
Title
Rescue Medication Use
Description
Assessment of rescue medication use by caregiver report.
Time Frame
At baseline, 4 months, 8 months, 12 months
Title
Clinic Visit Attendance Rate
Description
Participant clinic attendance / Completion rate for Telemedicine and In-Person group.
Time Frame
At baseline, 4 months, 8 months, 12 months
Title
Visit Satisfaction
Description
Participant report of satisfaction with asthma follow up visit
Time Frame
At baseline, 4 months, 8 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara T. Perry, MD
Organizational Affiliation
Arkansas Children's Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Telehealth Enhanced Asthma Management
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