AsthmaED-AMAPNCT02787174
A Computer-Based ED Intervention to Improve Pediatric Asthma Medicine Adherence
A study testing Asthma Medication Adherence Education in people with Asthma, run by Rhode Island Hospital at 1 site in United States.
Trial summary
Asthma is common in children and impacts their health. There are effective medications for improving asthma, but some families have difficulty using medicines on a regular basis. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Asthma Medication Adherence Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jul 2018
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Asthma diagnosis by physician or parent report
- Ages 2-12
- Prescribed an inhaled corticosteroid asthma controller medicine
Who cannot join
- Parent does not speak English
- Child is prescribed inhaled corticosteroid seasonally
- Patient is on a combination inhaled corticosteroid controller asthma med
Trial locations and contacts
1 site in 1 country.
United States1 site
Hasbro Children's Hospital
Providence, Rhode Island, 02905
About this study
Asthma is common in children and impacts their health. There are effective medications for improving asthma, but some families have difficulty using medicines on a regular basis. This study in the emergency department will improve medicine use for children 2-12 years-old with asthma by developing content for a customized, tablet-based electronic intervention. A clinical trial will then be used to compare asthma outcomes for this intervention with routine asthma care.
Read the detailed description
The investigators have used focus groups to get ideas from parents of children with asthma to best design the intervention. This has helped us create the questions that are being used in the intervention, and make the computer program appealing and acceptable to parents of children with asthma.
The investigators will study the success of the intervention for children who receive it compared to children who obtain routine emergency department care. Participants who receive the intervention will complete a series of questions on a tablet computer. Questions will guide creation of individualized education and advice to improve medication use for each participant. The intervention will also allow for customized communication with each child's primary care provider. The investigators will include educational boosters at 2 and 4 weeks after the intervention delivered as chosen by the participant (email / text / RSS / mail). Children in the routine asthma care arm will not receive the intervention, and instead will receive routine discharge instructions by the emergency room doctors.
The investigators will compare the success of the intervention group to routine emergency department care by using a device (DOSER CT) that measures daily administered doses of medicine. Data from the DOSER CT will be collected monthly at home visits for three months. The investigators will also measure health care use and quality-of-life for each child using a survey at these home visits. The investigators believe that the intervention will improve doses of medicine given, reduce unnecessary health care use, and improve children's quality of life.
- Conditions
- Asthma
- Being tested
- Asthma Medication Adherence Education
- Keywords
- Asthma, Medication adherence, Intervention study
- Medical subject headings
- Asthma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma Medication Adherence EducationOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will receive routine clinical treatment care. |
| Intervention | Experimental | Participants will receive interactive tailored asthma medication adherence education on an iPad. Receives: Other: Asthma Medication Adherence Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma controller medication adherence
Percentage adherent days defined as at least half of prescribed doses taken as measured by Doser CT
Measured: 12 weeks
Secondary outcomes (3)
Unscheduled healthcare use (self-report survey and chart review)
Unscheduled healthcare use (Emergency Department visits, doctor visits, hospitalizations)
Measured: 6 months
Quality-of-Life (QOL)
QOL measurement using Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF)
Measured: 6 months
Sustained Asthma controller medication adherence
Percentage adherent days defined as at least half of prescribed doses taken as measured by Doser CT
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2018
- Study completionJul 2018
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Aris Garro, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787174
- Sponsor's protocol ID
- 629210
- Other IDs
- R21HD082621
- Acronym
- ED-AMAP
- Status last verified
- Mar 2020
- First submitted
- 19 May 2016
- Last updated
- 10 Mar 2020
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Computer-Based ED Intervention to Improve Pediatric Asthma Medicine Adherence
- ClinicalTrials.gov ID
- NCT02787174
- Acronym / sponsor ID
- ED-AMAP / 629210
- Conditions
- Asthma
- Keywords
- Asthma, Medication adherence, Intervention study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Feb 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 1 Jun 2016 (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.
Asthma is common in children and impacts their health. There are effective medications for improving asthma, but some families have difficulty using medicines on a regular basis. This study in the emergency department will improve medicine use for children 2-12 years-old with asthma by developing content for a customized, tablet-based electronic intervention. A clinical trial will then be used to compare asthma outcomes for this intervention with routine asthma care.
Detailed description
The investigators have used focus groups to get ideas from parents of children with asthma to best design the intervention. This has helped us create the questions that are being used in the intervention, and make the computer program appealing and acceptable to parents of children with asthma.
The investigators will study the success of the intervention for children who receive it compared to children who obtain routine emergency department care. Participants who receive the intervention will complete a series of questions on a tablet computer. Questions will guide creation of individualized education and advice to improve medication use for each participant. The intervention will also allow for customized communication with each child's primary care provider. The investigators will include educational boosters at 2 and 4 weeks after the intervention delivered as chosen by the participant (email / text / RSS / mail). Children in the routine asthma care arm will not receive the intervention, and instead will receive routine discharge instructions by the emergency room doctors.
The investigators will compare the success of the intervention group to routine emergency department care by using a device (DOSER CT) that measures daily administered doses of medicine. Data from the DOSER CT will be collected monthly at home visits for three months. The investigators will also measure health care use and quality-of-life for each child using a survey at these home visits. The investigators believe that the intervention will improve doses of medicine given, reduce unnecessary health care use, and improve children's quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will receive routine clinical treatment care. |
| Intervention | Experimental | Other: Asthma Medication Adherence EducationParticipants will receive interactive tailored asthma medication adherence education on an iPad. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Asthma diagnosis by physician or parent report
- Ages 2-12
- Prescribed an inhaled corticosteroid asthma controller medicine
Key exclusion criteria (3 listed)
- Parent does not speak English
- Child is prescribed inhaled corticosteroid seasonally
- Patient is on a combination inhaled corticosteroid controller asthma med
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 Medication Adherence Education | Other | Intervention |
Primary outcome
Asthma controller medication adherence
Time frame: 12 weeks
Percentage adherent days defined as at least half of prescribed doses taken as measured by Doser CT
3 secondary outcomes
Unscheduled healthcare use (self-report survey and chart review)
Time frame: 6 months
Quality-of-Life (QOL)
Time frame: 6 months
Sustained Asthma controller medication adherence
Time frame: 3 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 10 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Medication Adherence Education in people with Asthma, run by Rhode Island 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 3 inclusion and 3 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 10 Mar 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?
Asthma controller medication adherence (time frame: 12 weeks). 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 10 Mar 2020.