AsthmaTAACNCT03187119
Investigation of the Role of Pictorial Asthma Action Plans to Promote Self-management in Rural Youth With Asthma
A study testing Pictorial Asthma Action Plan and Written Asthma Action Plan in people with Asthma, run by West Virginia University at 1 site in United States.
Trial summary
The aim of this study is to investigate the potential benefit of Pictorial versus Written Asthma Action Plans (AAPs) to support asthma management among young people with persistent asthma. Participants will be randomly allocated to the Pictorial or Written AAP group and followed up over a 6-month period. Read more about this study
- Who is it for?
- Ages 8 to 17 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
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2017to 12 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 8-17 years
- new patient (to clinic) with a diagnosis of persistent asthma or an established patient with uncontrolled persistent asthma and a clinical need for a new treatment regimen
- no history of having received a written AAP
- prescribed an inhaled corticosteroid (i.e., daily controller medication).
Who cannot join
- patients and caregivers who do not use English as their primary language
- has a significant developmental (e.g., autism, intellectual disability) or sensory (e.g., blindness) disorder that would preclude completion of study measures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Take Action for Asthma Control Study - Pilot Randomized Controlled Trial of Pictorial Asthma Action Plans to Promote Self-management and Health in Rural Youth With Asthma
The aim of this study is to investigate the potential benefit of Pictorial versus Written Asthma Action Plans (AAPs) to support asthma management among young people with persistent asthma. Participants will be randomly allocated to the Pictorial or Written AAP group and followed up over a 6-month period. Qualitative and quantitative data will be collected from young people, parents and clinical teams involved in recruitment to assess the feasibility and acceptability of the Pictorial AAP (PAAP) software developed for this study, the PAAPs produced by the software, and the study procedures.
Read the detailed description
Asthma is the most common chronic health condition of childhood, and continues to be associated with morbidity and mortality. Many children with persistent asthma follow a treatment plan including a prescription to take a daily inhaled corticosteroid (controller), often in conjunction with a daily oral controller medication, and a dose of an albuterol (rescue) inhaler before activity or exercise. Young people with asthma must add to this treatment plan in response to a flare in symptoms by taking additional medication and contacting their asthma provider or getting to a hospital. Adherence to daily medications is essential for maintaining lung health and reducing symptom flares, but asthma treatment is complex, requiring regular decision-making in response to symptoms and environmental issues like symptom triggers. As a result consistent adherence is a challenge for families and young people. It is recommended to provide an Asthma Action Plan (AAP) to all people diagnosed with asthma, summarizing their treatment plan using a traffic light format; Green Zone for daily, symptom-free management, Yellow Zone for symptom flare, and Red Zone for extreme symptom flare. Despite evidence for the effectiveness of AAPs, they are often not prescribed for reasons including readability and accessibility for families and young people, and asthma provider perceptions of their utility and suitability. In this study, young people with persistent asthma will be given a Written (WAAP) or Pictorial Asthma Action Plan (PAAP) to compare the differential impact on AAP knowledge, adherence to daily inhaler use, and asthma control. Software developed for the study, in collaboration with providers, young people with asthma and their parents, will be used to generate personalized PAAPs. Quantitative and qualitative data will be collected to explore perceptions of providers, parents and young people of different versions of AAPs, the influence of AAPs on asthma understanding and management, and the experience of taking part in the study, as well as to assess the impact of different AAPs on the asthma and psychosocial outcomes mentioned. The findings will inform the development of the PAAP software and as the basis for a definitive Randomized Controlled Trial of the efficacy of PAAPs.
- Conditions
- Asthma
- Being tested
- Pictorial Asthma Action Plan, Written Asthma Action Plan
- Keywords
- Pediatric, Education, Technology-supported intervention, Asthma Action Plan, Health literacy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pictorial Asthma Action PlanBehavioural
Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP.
Written Asthma Action PlanBehavioural
Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP.
| Study group | Role | What they receive |
|---|---|---|
| Pictorial Asthma Action Plan | Experimental | Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP. Receives: Behavioral: Pictorial Asthma Action Plan |
| Written Asthma Action Plan | Active comparator | Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP. Receives: Behavioral: Written Asthma Action Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Asthma Action Plan Knowledge Interview (AAPKI)-Child
The Asthma Action Plan Knowledge Interview (AAPKI) was developed for the purposes of this study. The first section of the structured interview included 8 items describing hypothetical situations in which the respondent was asked to categorize themselves or their child into one of three zones. These items were scored as correct (1) or incorrect (0). Two items were excluded because they were not relevant to all participants. The second section of the structured interview included 3 open response items asking the respondent to describe the treatment instructions for the three zones according to the AAP. Responses were coded on a 4-point scale: 0 = incorrect; 1 = possibly correct, but vague or missing important details; 2 = correct but not detailed; 3 = correct and specific. Percent correct knowledge scores were calculated using six items from the first section and the three additional questions about treatment, for a total of nine questions.
Measured: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
The Asthma Action Plan Knowledge Interview (AAPKI)-Parent
The Asthma Action Plan Knowledge Interview (AAPKI) was developed for the purposes of this study. The first section of the structured interview included 8 items describing hypothetical situations in which the respondent was asked to categorize their child into one of three zones. These items were scored as correct (1) or incorrect (0). Two items were excluded because they were not relevant to all participants. The second section of the structured interview included 3 open response items asking the respondent to describe the treatment instructions for the three zones according to the AAP. Responses were coded on a 4-point scale: 0 = incorrect; 1 = possibly correct, but vague or missing important details; 2 = correct but not detailed; 3 = correct and specific. Percent correct knowledge scores were calculated using six items from the first section and the three additional questions about treatment, for a total of nine questions.
Measured: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
Asthma Control Test
Asthma control was measures via the Asthma Control Test (ACT) 12 for participants 12 and older (7 items), and the ACT 11 for participants 11 and younger (5 items). These scales include a 5 point Likert type response. Total score is calculated by summing response with higher scores indicating more control. Possible range of scores is 0-35. The raw scores were dichotomized for a clinical cut-off, with a score of 19 and less considered "poor control".
Measured: Measured at four time points over 6 months; baseline, 1-, 3- and 6-month follow-up.
Adherence to Daily Controller Inhaler
Adherence to daily controller inhaler measured objectively using an electronic monitor attached to the inhaler and connected to a smart phone application or 'hub' in the participant's home.Data was examined for daily percent adherence by comparing the number of puffs taken with the number of puffs prescribed. Day 180 was not included in the analyses due to low insufficient group size.
Measured: Measured over 6 months; day 1, day 30, day 90 and day 180
Lung Function-FEV1
Lung function was assessed using spirometry outcome of Forced Expiratory Volume (FEV1),
Measured: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
Lung Function- FEF 25-75
This data is gathered from a spirometry test. FEF 25-75 is the air flow between 25% and 75% of forced vital capacity.
Measured: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
Secondary outcomes (2)
Satisfaction With Asthma Action Plan-Caregiver
Satisfaction questions were developed for this project and a final questionnaire developed. The Satisfaction questionnaire was completed by both parents and children at post-test (1 month, and 3 or 6 months). The scale included 11 questions, 5 reverse coded, on a 4 point Likert-type response scale. A mean item score was generated; higher scores indicate higher levels of satisfaction. Possible range of mean score was 0-4.
Measured: Measured at two time points over 6 months; 1- and 6-month follow-up.
Satisfaction With Asthma Action Plan-Patient
Satisfaction questions were developed for this project and a final questionnaire developed. The Satisfaction questionnaire was completed by both parents and children at post-test (1 month, and 3 or 6 months). The scale included 11 questions, 5 reverse coded, on a 4 point Likert-type response scale. Items were averaged together for a mean score; higher scores indicate higher levels of satisfaction. Possible range of mean score was 0-4.
Measured: Measured at two time points over 6 months; 1- and 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start24 May 2017
- Primary completion12 Nov 2018
- Study completion12 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Duncan, West Virginia University
- Investigators
- Christina Duncan, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187119
- Sponsor's protocol ID
- 1612396282
- Acronym
- TAAC
- Status last verified
- Oct 2021
- First submitted
- 7 Jun 2017
- Last updated
- 22 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Take Action for Asthma Control Study - Pilot Randomized Controlled Trial of Pictorial Asthma Action Plans to Promote Self-management and Health in Rural Youth With Asthma
- ClinicalTrials.gov ID
- NCT03187119
- Acronym / sponsor ID
- TAAC / 1612396282
- Conditions
- Asthma
- Keywords
- Pediatric, Education, Technology-supported intervention, Asthma Action Plan, Health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 24 May 2017 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Posted 22 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the potential benefit of Pictorial versus Written Asthma Action Plans (AAPs) to support asthma management among young people with persistent asthma. Participants will be randomly allocated to the Pictorial or Written AAP group and followed up over a 6-month period. Qualitative and quantitative data will be collected from young people, parents and clinical teams involved in recruitment to assess the feasibility and acceptability of the Pictorial AAP (PAAP) software developed for this study, the PAAPs produced by the software, and the study procedures.
Detailed description
Asthma is the most common chronic health condition of childhood, and continues to be associated with morbidity and mortality. Many children with persistent asthma follow a treatment plan including a prescription to take a daily inhaled corticosteroid (controller), often in conjunction with a daily oral controller medication, and a dose of an albuterol (rescue) inhaler before activity or exercise. Young people with asthma must add to this treatment plan in response to a flare in symptoms by taking additional medication and contacting their asthma provider or getting to a hospital. Adherence to daily medications is essential for maintaining lung health and reducing symptom flares, but asthma treatment is complex, requiring regular decision-making in response to symptoms and environmental issues like symptom triggers. As a result consistent adherence is a challenge for families and young people. It is recommended to provide an Asthma Action Plan (AAP) to all people diagnosed with asthma, summarizing their treatment plan using a traffic light format; Green Zone for daily, symptom-free management, Yellow Zone for symptom flare, and Red Zone for extreme symptom flare. Despite evidence for the effectiveness of AAPs, they are often not prescribed for reasons including readability and accessibility for families and young people, and asthma provider perceptions of their utility and suitability. In this study, young people with persistent asthma will be given a Written (WAAP) or Pictorial Asthma Action Plan (PAAP) to compare the differential impact on AAP knowledge, adherence to daily inhaler use, and asthma control. Software developed for the study, in collaboration with providers, young people with asthma and their parents, will be used to generate personalized PAAPs. Quantitative and qualitative data will be collected to explore perceptions of providers, parents and young people of different versions of AAPs, the influence of AAPs on asthma understanding and management, and the experience of taking part in the study, as well as to assess the impact of different AAPs on the asthma and psychosocial outcomes mentioned. The findings will inform the development of the PAAP software and as the basis for a definitive Randomized Controlled Trial of the efficacy of PAAPs.
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 PlanYoung people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP. |
| Written Asthma Action Plan | Active comparator | Behavioral: Written Asthma Action PlanYoung people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age 8-17 years
- new patient (to clinic) with a diagnosis of persistent asthma or an established patient with uncontrolled persistent asthma and a clinical need for a new treatment regimen
- no history of having received a written AAP
- prescribed an inhaled corticosteroid (i.e., daily controller medication).
Key exclusion criteria (2 listed)
- patients and caregivers who do not use English as their primary language
- has a significant developmental (e.g., autism, intellectual disability) or sensory (e.g., blindness) disorder that would preclude completion of study measures.
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 PlanParticipants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP. | Behavioural | Pictorial Asthma Action Plan |
| Written Asthma Action PlanParticipants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP. | Behavioural | Written Asthma Action Plan |
Primary outcome
The Asthma Action Plan Knowledge Interview (AAPKI)-Child
Time frame: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
The Asthma Action Plan Knowledge Interview (AAPKI) was developed for the purposes of this study. The first section of the structured interview included 8 items describing hypothetical situations in which the respondent was asked to categorize themselves or their child into one of three zones. These items were scored as correct (1) or incorrect (0). Two items were excluded because they were not relevant to all participants. The second section of the structured interview included 3 open response items asking the respondent to describe the treatment instructions for the three zones according to the AAP. Responses were coded on a 4-point scale: 0 = incorrect; 1 = possibly correct, but vague or missing important details; 2 = correct but not detailed; 3 = correct and specific. Percent correct knowledge scores were calculated using six items from the first section and the three additional questions about treatment, for a total of nine questions.
The Asthma Action Plan Knowledge Interview (AAPKI)-Parent
Time frame: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
The Asthma Action Plan Knowledge Interview (AAPKI) was developed for the purposes of this study. The first section of the structured interview included 8 items describing hypothetical situations in which the respondent was asked to categorize their child into one of three zones. These items were scored as correct (1) or incorrect (0). Two items were excluded because they were not relevant to all participants. The second section of the structured interview included 3 open response items asking the respondent to describe the treatment instructions for the three zones according to the AAP. Responses were coded on a 4-point scale: 0 = incorrect; 1 = possibly correct, but vague or missing important details; 2 = correct but not detailed; 3 = correct and specific. Percent correct knowledge scores were calculated using six items from the first section and the three additional questions about treatment, for a total of nine questions.
Asthma Control Test
Time frame: Measured at four time points over 6 months; baseline, 1-, 3- and 6-month follow-up.
Asthma control was measures via the Asthma Control Test (ACT) 12 for participants 12 and older (7 items), and the ACT 11 for participants 11 and younger (5 items). These scales include a 5 point Likert type response. Total score is calculated by summing response with higher scores indicating more control. Possible range of scores is 0-35. The raw scores were dichotomized for a clinical cut-off, with a score of 19 and less considered "poor control".
Adherence to Daily Controller Inhaler
Time frame: Measured over 6 months; day 1, day 30, day 90 and day 180
Adherence to daily controller inhaler measured objectively using an electronic monitor attached to the inhaler and connected to a smart phone application or 'hub' in the participant's home.Data was examined for daily percent adherence by comparing the number of puffs taken with the number of puffs prescribed. Day 180 was not included in the analyses due to low insufficient group size.
Lung Function-FEV1
Time frame: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
Lung function was assessed using spirometry outcome of Forced Expiratory Volume (FEV1),
Lung Function- FEF 25-75
Time frame: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
This data is gathered from a spirometry test. FEF 25-75 is the air flow between 25% and 75% of forced vital capacity.
2 secondary outcomes
Satisfaction With Asthma Action Plan-Caregiver
Time frame: Measured at two time points over 6 months; 1- and 6-month follow-up.
Satisfaction With Asthma Action Plan-Patient
Time frame: Measured at two time points over 6 months; 1- and 6-month follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Christina Duncan, PhD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pictorial Asthma Action Plan and Written Asthma Action Plan in people with Asthma, run by West Virginia University 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 2 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 22 Oct 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Asthma Action Plan Knowledge Interview (AAPKI)-Child (time frame: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.). The study lists 6 primary outcomes in all. 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 22 Oct 2021.