Telehealth Enhanced Asthma Management

NCT ID: NCT03414177

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-06

Study Completion Date

2019-10-01

Brief Summary

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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

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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).

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Asthma Subspecialty Follow-up Visits

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Asthma Subspecialty Follow-up Visits

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tamara T. Perry, MD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Children's Research Institute

Locations

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Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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207015

Identifier Type: -

Identifier Source: org_study_id

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