Telehealth Enhanced Asthma Management

NCT03414177 | Completed

• 1 other identifier: 207015
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Telemedicine; Clinical follow up visits

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Routine Follow up Asthma Visit

  At baseline, 4 months, 8 months, 12 months

• Lung Function via Spirometry

  Baseline and 12 months

• Airway Inflammation via Spirometry

  Baseline and 12 months

• Healthcare Utilization

  At baseline, 4 months, 8 months, 12 months

• Medication Adherence

  At baseline, 4 months, 8 months, 12 months

Study Arms (2)

Telemedicine Group

ACTIVE COMPARATOR

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

In-Person Group

ACTIVE COMPARATOR

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

Interventions

Asthma Subspecialty Follow-up Visits OTHER

Pediatric patients with persistent asthma will be recruited to compare outcomes among patients with follow-up visits managed via telemedicine vs. in-person visits.

In-Person Group; Telemedicine Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Tamara T. Perry, MD

  Arkansas Children's Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 29, 2018
• Study Start: March 6, 2018
• Primary Completion: August 8, 2019
• Study Completion: October 1, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)