Clinical trial NCT03414177: Telehealth Enhanced Asthma Management
Official title: Telehealth Enhanced Asthma Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Telemedicine
Clinical follow up visits
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Mean difference in ACT score at the final assessment (12 months) after adjusting for baseline
timeFrame: At baseline and 12 months
Secondary outcomes:
measure: Routine Follow up Asthma Visit
timeFrame: At baseline, 4 months, 8 months, 12 months
measure: Lung Function via Spirometry
timeFrame: Baseline and 12 months
measure: Airway Inflammation via Spirometry
timeFrame: Baseline and 12 months
measure: Healthcare Utilization
timeFrame: At baseline, 4 months, 8 months, 12 months
measure: Medication Adherence
timeFrame: At baseline, 4 months, 8 months, 12 months
measure: Rescue Medication Use
timeFrame: At baseline, 4 months, 8 months, 12 months
measure: Clinic Visit Attendance Rate
timeFrame: At baseline, 4 months, 8 months, 12 months
measure: Visit Satisfaction
timeFrame: At baseline, 4 months, 8 months, 12 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
Study officials:
affiliation: Arkansas Children's Research Institute
name: Tamara T. Perry, MD
role: PRINCIPAL_INVESTIGATOR
References: