AsthmaPhase 2NCT00136305
Comparing Asthma Action Plans for Pediatric Asthma
A Phase 2 study testing Pictorial asthma action plan and Written asthma action plan in people with Asthma, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and compare the relative effectiveness of two asthma action plans (pictorial versus written) in terms of asthma action plan knowledge, medication use, and family satisfaction with asthma education. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- Pictorial asthma action plan and Written asthma action plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to May 2006
- Phase
- Phase 2
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children who are new patients
- Receive a diagnosis of persistent asthma
- Are in need of an asthma action plan
Who cannot join
- Diagnosed with intermittent asthma
- An established patient who already has an asthma action plan
- Not English or Spanish speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
About this study
Official title: Relative Effectiveness of Pictorial and Written Asthma Action Plans for Pediatric Asthma
The purpose of this study is to evaluate and compare the relative effectiveness of two asthma action plans (pictorial versus written) in terms of asthma action plan knowledge, medication use, and family satisfaction with asthma education.
Read the detailed description
Asthma medical regimens are complex for families, requiring changes in the types and amounts of medication based on the frequency and intensity of symptoms. Written asthma action plans (AAP's) are commonly used to provide a set of instructions to help parents and children implement these complicated regimens. However, written AAP's require substantial literacy levels, so for younger children, low-literacy families, or non-English speaking families, a pictorial version of the AAP may be more understandable and useful. The study aims to validate a newly developed, fully pictorial AAP in terms of its relative impact on parent- and child-reported knowledge of the action plan, medication use, and parent- and child-reported satisfaction, when compared to a standard-care written AAP.
- Conditions
- Asthma
- Being tested
- Pictorial asthma action plan, Written asthma action plan
- Keywords
- pediatric asthma, asthma action plans, patient education, medication adherence
- 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.
Pictorial asthma action planBehavioural
Written asthma action planBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Pictorial Asthma Action Plan | Experimental | Not described Receives: Behavioral: Pictorial asthma action plan |
| Written Asthma Action Plan | Active comparator | Not described Receives: Behavioral: Written asthma action plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on the Asthma Action Plan Knowledge Interview
Measures recall of asthma treatment plan
Measured: 1 month
Secondary outcomes (3)
Adherence to Controller Medication
Mean daily adherence to medication measured via electronic monitoring
Measured: 1 month
Rescue Medication Use
Number of puffs of inhaled rescue medication
Measured: 1 month
Family satisfaction survey scores
Family ratings of satisfaction with asthma action plan
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionMay 2006
Why it stopped: PI moved to a different institution
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Katherine B. Anderson Associates Endowment Fund
- Responsible party
- Sponsor
- Investigators
- Christina D Adams, PhD, Principal investigator, The Children's Mercy Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136305
- Sponsor's protocol ID
- 04 08-102E
- Other IDs
- KBR 01.4182
- Status last verified
- Aug 2021
- First submitted
- 26 Aug 2005
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Effectiveness of Pictorial and Written Asthma Action Plans for Pediatric Asthma
- ClinicalTrials.gov ID
- NCT00136305
- Acronym / sponsor ID
- 04 08-102E
- Conditions
- Asthma
- Keywords
- pediatric asthma, asthma action plans, patient education, medication adherence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI moved to a different institution
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- Katherine B. Anderson Associates Endowment Fund
- Study start
- Aug 2005
- Primary completion
- May 2006 (actual)
- First posted
- 29 Aug 2005 (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.
The purpose of this study is to evaluate and compare the relative effectiveness of two asthma action plans (pictorial versus written) in terms of asthma action plan knowledge, medication use, and family satisfaction with asthma education.
Detailed description
Asthma medical regimens are complex for families, requiring changes in the types and amounts of medication based on the frequency and intensity of symptoms. Written asthma action plans (AAP's) are commonly used to provide a set of instructions to help parents and children implement these complicated regimens. However, written AAP's require substantial literacy levels, so for younger children, low-literacy families, or non-English speaking families, a pictorial version of the AAP may be more understandable and useful. The study aims to validate a newly developed, fully pictorial AAP in terms of its relative impact on parent- and child-reported knowledge of the action plan, medication use, and parent- and child-reported satisfaction, when compared to a standard-care written AAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pictorial Asthma Action Plan | Experimental | Behavioral: Pictorial asthma action plan |
| Written Asthma Action Plan | Active comparator | Behavioral: Written asthma action plan |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children who are new patients
- Receive a diagnosis of persistent asthma
- Are in need of an asthma action plan
Key exclusion criteria (3 listed)
- Diagnosed with intermittent asthma
- An established patient who already has an asthma action plan
- Not English or Spanish speaking
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 |
|---|---|---|
| Pictorial asthma action plan | Behavioural | Pictorial Asthma Action Plan |
| Written asthma action plan | Behavioural | Written Asthma Action Plan |
Primary outcome
Scores on the Asthma Action Plan Knowledge Interview
Time frame: 1 month
Measures recall of asthma treatment plan
3 secondary outcomes
Adherence to Controller Medication
Time frame: 1 month
Rescue Medication Use
Time frame: 1 month
Family satisfaction survey scores
Time frame: 1 month
Results and safety
The study was stopped early (reason given: PI moved to a different institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
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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.
Christina D Adams, PhD principal investigator
The Children's Mercy Hospitals and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pictorial asthma action plan and Written asthma action plan in people with Asthma, run by Children's Mercy Hospital Kansas City 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: stopped early, as of the sponsor's last update on 26 Aug 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI moved to a different institution). Results are not available in the source record.
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?
Scores on the Asthma Action Plan Knowledge Interview (time frame: 1 month). 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 26 Aug 2021.