AsthmaNCT03036982
Remote Use of the Asthma Control Test (ACT) to Improve Care of Children With Asthma
An observational study of Asthma, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study will assess whether adaption of the Asthma Control Test (ACT) and childhood Asthma Control Test (cACT) for mobile devices improves rate of completion and improves control of asthma in children and adolescents Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Asthma
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 31 Dec 2017
- Phase
- Observational
- 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 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with asthma seen in one of the clinics caring for patients with asthma at Boston Children's Hospital Age 4-21
Who may be able to join
- Diagnosis of asthma
- Cared for at Boston Children's Hospital (Primary or secondary care)
Who cannot join
- Age <4 or >21
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Childrens Hospital
Boston, Massachusetts, 02115
About this study
This study will assess whether adaption of the Asthma Control Test (ACT) and childhood Asthma Control Test (cACT) for mobile devices improves rate of completion and improves control of asthma in children and adolescents
Read the detailed description
Asthma is the most prevalent chronic disease of childhood with an overall prevalence of 10%. While effective therapies exist to control symptoms and prevent exacerbations, many asthma patients experience significant morbidity including limitations on daily activities as well as asthma exacerbations that lead to missed school (and work for care givers) and necessitate emergency department visits and hospitalizations. Among children from lower socioeconomic statues and in black and Hispanic families, asthma incidence and severity are even greater. Reasons for this disparity included decreased access to effective asthma care, increased exposure to tobacco smoke and environmental allergens, and underutilization of controller medicines. These groups have significantly increased resource utilization due to emergency department visits and hospitalizations. Optimal care for asthma patients, especially those with at highest risk, will therefore require new strategies for evaluating ongoing control and providing direct feedback to patients.
We propose to transform the way asthma care is provided through the use of an innovative patient centered technology -Trivox Asthma - to improve quality of care and outcomes for asthma patients while reducing the cost of care. Specifically we will extend Trivox Health to facilitate closer monitoring of patients with asthma through the existing web platform and a new mobile interface. This will allow asthma patients, their parents and school nurses to remotely input data on asthma control through smartphones and/or tablets. We will use the ACT+, an expansion of a validated measure currently utilized in both primary care and specialty clinics, to measure both asthma control and risk.
Effectiveness of this intervention will be measured by examining resource utilization and ongoing asthma control.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Use of Mobile ACT | Will answer ACT (or cACT) and other asthma questions using mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-controlled asthma
Percent of ACT scores with value of 20 or greater
Measured: Each month for one calendar year
Secondary outcomes (1)
Asthma Emergency Department visits and hospitalizations
Asked every 3 months
Measured: Total Emergency Department Visits and hospitalizations with asthma as one of top diagnosis in one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Jan 2016
- Primary completion30 Apr 2017
- Study completion31 Dec 2017
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.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew MacGinnitie, Boston Children's Hospital
- Investigators
- Andrew MacGinnitie, MD PhD, Principal investigator, Boston Children's Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036982
- Sponsor's protocol ID
- FP01013808
- Status last verified
- Mar 2018
- First submitted
- 27 Jul 2015
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Will make deidentified data available for other researchers
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Use of the Asthma Control Test (ACT) to Improve Care of Children With Asthma
- ClinicalTrials.gov ID
- NCT03036982
- Acronym / sponsor ID
- FP01013808
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 31 Jan 2017 (estimated)
- 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 assess whether adaption of the Asthma Control Test (ACT) and childhood Asthma Control Test (cACT) for mobile devices improves rate of completion and improves control of asthma in children and adolescents
Detailed description
Asthma is the most prevalent chronic disease of childhood with an overall prevalence of 10%. While effective therapies exist to control symptoms and prevent exacerbations, many asthma patients experience significant morbidity including limitations on daily activities as well as asthma exacerbations that lead to missed school (and work for care givers) and necessitate emergency department visits and hospitalizations. Among children from lower socioeconomic statues and in black and Hispanic families, asthma incidence and severity are even greater. Reasons for this disparity included decreased access to effective asthma care, increased exposure to tobacco smoke and environmental allergens, and underutilization of controller medicines. These groups have significantly increased resource utilization due to emergency department visits and hospitalizations. Optimal care for asthma patients, especially those with at highest risk, will therefore require new strategies for evaluating ongoing control and providing direct feedback to patients.
We propose to transform the way asthma care is provided through the use of an innovative patient centered technology -Trivox Asthma - to improve quality of care and outcomes for asthma patients while reducing the cost of care. Specifically we will extend Trivox Health to facilitate closer monitoring of patients with asthma through the existing web platform and a new mobile interface. This will allow asthma patients, their parents and school nurses to remotely input data on asthma control through smartphones and/or tablets. We will use the ACT+, an expansion of a validated measure currently utilized in both primary care and specialty clinics, to measure both asthma control and risk.
Effectiveness of this intervention will be measured by examining resource utilization and ongoing asthma control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of Mobile ACT | – | –Will answer ACT (or cACT) and other asthma questions using mobile app |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with asthma seen in one of the clinics caring for patients with asthma at Boston Children's Hospital Age 4-21
Key inclusion criteria (2 listed)
- Diagnosis of asthma
- Cared for at Boston Children's Hospital (Primary or secondary care)
Key exclusion criteria (1 listed)
- Age <4 or >21
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Well-controlled asthma
Time frame: Each month for one calendar year
Percent of ACT scores with value of 20 or greater
1 secondary outcome
Asthma Emergency Department visits and hospitalizations
Time frame: Total Emergency Department Visits and hospitalizations with asthma as one of top diagnosis in one year
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 27 Mar 2018.
- Individual participant dataSharing planned: Yes. Will make deidentified data available for other researchers
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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.
Andrew MacGinnitie, MD PhD principal investigator
Boston Children's Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Boston Children's Hospital 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 2 inclusion and 1 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 27 Mar 2018. 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?
Well-controlled asthma (time frame: Each month for one calendar year). 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 27 Mar 2018.