Telehealth Enhanced Asthma Management

Asthma Clinical Trial

— TEAM  

Official title:

Telehealth Enhanced Asthma Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414177
• Other study ID #: 207015
• Status: Completed
• Phase: N/A
• Start date: March 6, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: October 2020
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 1, 2019
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline and 12 months
Secondary	Routine Follow up Asthma Visit	Physical examination to assess current asthma problems, symptoms, medication and the child's overall health.	At baseline, 4 months, 8 months, 12 months
Secondary	Lung Function via Spirometry	Spirometry	Baseline and 12 months
Secondary	Airway Inflammation via Spirometry	Spirometry	Baseline and 12 months
Secondary	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.	At baseline, 4 months, 8 months, 12 months
Secondary	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.	At baseline, 4 months, 8 months, 12 months
Secondary	Rescue Medication Use	Assessment of rescue medication use by caregiver report.	At baseline, 4 months, 8 months, 12 months
Secondary	Clinic Visit Attendance Rate	Participant clinic attendance / Completion rate for Telemedicine and In-Person group.	At baseline, 4 months, 8 months, 12 months
Secondary	Visit Satisfaction	Participant report of satisfaction with asthma follow up visit	At baseline, 4 months, 8 months, 12 months