AsthmaTEAMNCT03414177
Telehealth Enhanced Asthma Management
A study testing Asthma Subspecialty Follow-up Visits in people with Asthma, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Asthma Subspecialty Follow-up Visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2018to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
About this study
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.
Read the 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).
- Conditions
- Asthma
- Being tested
- Asthma Subspecialty Follow-up Visits
- Keywords
- Telemedicine, Clinical follow up visits
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma Subspecialty Follow-up VisitsOther
Pediatric patients with persistent asthma will be recruited to compare outcomes among patients with follow-up visits managed via telemedicine vs. in-person visits.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Asthma Subspecialty Follow-up Visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and 12 months
Secondary outcomes (8)
Routine Follow up Asthma Visit
Physical examination to assess current asthma problems, symptoms, medication and the child's overall health.
Measured: At baseline, 4 months, 8 months, 12 months
Lung Function via Spirometry
Spirometry
Measured: Baseline and 12 months
Airway Inflammation via Spirometry
Spirometry
Measured: Baseline and 12 months
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.
Measured: At baseline, 4 months, 8 months, 12 months
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.
Measured: At baseline, 4 months, 8 months, 12 months
Rescue Medication Use
Assessment of rescue medication use by caregiver report.
Measured: At baseline, 4 months, 8 months, 12 months
Clinic Visit Attendance Rate
Participant clinic attendance / Completion rate for Telemedicine and In-Person group.
Measured: At baseline, 4 months, 8 months, 12 months
Visit Satisfaction
Participant report of satisfaction with asthma follow up visit
Measured: At baseline, 4 months, 8 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start6 Mar 2018
- Primary completion8 Aug 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara T. Perry, MD, Principal investigator, Arkansas Children's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414177
- Sponsor's protocol ID
- 207015
- Acronym
- TEAM
- Status last verified
- Oct 2020
- First submitted
- 9 Jan 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Enhanced Asthma Management
- ClinicalTrials.gov ID
- NCT03414177
- Acronym / sponsor ID
- TEAM / 207015
- Conditions
- Asthma
- Keywords
- Telemedicine, Clinical follow up visits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Group | Active comparator | Other: Asthma Subspecialty Follow-up VisitsTelemedicine 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 Group | Active comparator | Other: Asthma Subspecialty Follow-up VisitsIn-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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asthma Subspecialty Follow-up VisitsPediatric patients with persistent asthma will be recruited to compare outcomes among patients with follow-up visits managed via telemedicine vs. in-person visits. | Other | In-Person Group, Telemedicine Group |
Primary outcome
Mean difference in ACT score at the final assessment (12 months) after adjusting for baseline
Time frame: At baseline and 12 months
ACT is used for symptoms monitoring as per guidelines and has been identified as an appropriate asthma control composite score in clinical research.
8 secondary outcomes
Routine Follow up Asthma Visit
Time frame: At baseline, 4 months, 8 months, 12 months
Lung Function via Spirometry
Time frame: Baseline and 12 months
Airway Inflammation via Spirometry
Time frame: Baseline and 12 months
Healthcare Utilization
Time frame: At baseline, 4 months, 8 months, 12 months
Medication Adherence
Time frame: At baseline, 4 months, 8 months, 12 months
Rescue Medication Use
Time frame: At baseline, 4 months, 8 months, 12 months
Clinic Visit Attendance Rate
Time frame: At baseline, 4 months, 8 months, 12 months
Visit Satisfaction
Time frame: At baseline, 4 months, 8 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara T. Perry, MD principal investigator
Arkansas Children's Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma Subspecialty Follow-up Visits in people with Asthma, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in ACT score at the final assessment (12 months) after adjusting for baseline (time frame: At baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.