Trial Outcomes & Findings for Investigation of the Role of Pictorial Asthma Action Plans to Promote Self-management in Rural Youth With Asthma (NCT NCT03187119)

Last Updated: 2021-10-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.

Results posted on

2021-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Pictorial Asthma Action Plan 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. Pictorial Asthma Action Plan: 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 Plan 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. Written Asthma Action Plan: 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.
Overall Study STARTED	22	23
Overall Study COMPLETED	20	18
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pictorial Asthma Action Plan n=22 Participants 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. Pictorial Asthma Action Plan: 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 Plan n=23 Participants 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. Written Asthma Action Plan: 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.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	22 Participants n=22 Participants	23 Participants n=23 Participants	45 Participants n=45 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=45 Participants
Age, Categorical >=65 years	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=45 Participants
Age, Continuous	11.70 years STANDARD_DEVIATION 2.91 • n=22 Participants	11.87 years STANDARD_DEVIATION 2.65 • n=23 Participants	11.79 years STANDARD_DEVIATION 2.75 • n=45 Participants
Sex: Female, Male Female	13 Participants n=22 Participants	14 Participants n=23 Participants	27 Participants n=45 Participants
Sex: Female, Male Male	9 Participants n=22 Participants	9 Participants n=23 Participants	18 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Asian	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Black or African American	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=45 Participants
Race (NIH/OMB) White	21 Participants n=22 Participants	22 Participants n=23 Participants	43 Participants n=45 Participants
Race (NIH/OMB) More than one race	1 Participants n=22 Participants	0 Participants n=23 Participants	1 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=22 Participants	1 Participants n=23 Participants	1 Participants n=45 Participants
Region of Enrollment United States	22 participants n=22 Participants	23 participants n=23 Participants	45 participants n=45 Participants
Caregiver Age	40.00 years STANDARD_DEVIATION 7.92 • n=22 Participants	42.26 years STANDARD_DEVIATION 9.88 • n=23 Participants	41.16 years STANDARD_DEVIATION 8.95 • n=45 Participants
Parental Education Mother · Less than High School	3 Participants n=22 Participants	7 Participants n=23 Participants	10 Participants n=45 Participants
Parental Education Mother · More than High School	19 Participants n=22 Participants	16 Participants n=23 Participants	35 Participants n=45 Participants
Parental Education Father · Less than High School	7 Participants n=22 Participants	11 Participants n=23 Participants	18 Participants n=45 Participants
Parental Education Father · More than High School	15 Participants n=22 Participants	12 Participants n=23 Participants	27 Participants n=45 Participants
Caregiver Marital Status Never Been Married / Single	2 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	0 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	2 Participants n=42 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).
Caregiver Marital Status Married to other biological parent	14 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	13 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	27 Participants n=42 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).
Caregiver Marital Status Living with boyfriend / girlfriend	1 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	2 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	3 Participants n=42 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).
Caregiver Marital Status Divorced / Single	0 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	4 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	4 Participants n=42 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).
Caregiver Marital Status Remarried to step-parent	3 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	2 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	5 Participants n=42 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).
Caregiver Marital Status Widowed (other biological parent is deceased)	1 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	0 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	1 Participants n=42 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).
Annual Household Income Less than $15,000	3 Participants n=22 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	2 Participants n=22 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	5 Participants n=44 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).
Annual Household Income 15,000 - $29,999	2 Participants n=22 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	6 Participants n=22 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	8 Participants n=44 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).
Annual Household Income $30,000 - $44,999	5 Participants n=22 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	3 Participants n=22 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	8 Participants n=44 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).
Annual Household Income $45,000 - $59,999	2 Participants n=22 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	1 Participants n=22 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	3 Participants n=44 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).
Annual Household Income $60,000 - $74,999	1 Participants n=22 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	4 Participants n=22 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	5 Participants n=44 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).
Annual Household Income $75,000 and greater	9 Participants n=22 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	6 Participants n=22 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	15 Participants n=44 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).
Child Prior Diagnosis of Asthma Yes	20 Participants n=22 Participants	19 Participants n=23 Participants	39 Participants n=45 Participants
Child Prior Diagnosis of Asthma No	2 Participants n=22 Participants	4 Participants n=23 Participants	6 Participants n=45 Participants
Child Age of Diagnosis of Asthma	3.94 years STANDARD_DEVIATION 2.93 • n=18 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., equipment).	7.30 years STANDARD_DEVIATION 1.38 • n=19 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., equipment).	5.67 years STANDARD_DEVIATION 4.07 • n=37 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., equipment).
Child Number of Relatives with Asthma Diagnosis Yes	18 Participants n=22 Participants	19 Participants n=23 Participants	37 Participants n=45 Participants
Child Number of Relatives with Asthma Diagnosis No	4 Participants n=22 Participants	4 Participants n=23 Participants	8 Participants n=45 Participants
Child Immediate Relatives Asthma Yes	13 Participants n=22 Participants	15 Participants n=23 Participants	28 Participants n=45 Participants
Child Immediate Relatives Asthma No	9 Participants n=22 Participants	8 Participants n=23 Participants	17 Participants n=45 Participants
Child Extended Relatives Asthma Yes	13 Participants n=22 Participants	16 Participants n=23 Participants	29 Participants n=45 Participants
Child Extended Relatives Asthma No	9 Participants n=22 Participants	7 Participants n=23 Participants	16 Participants n=45 Participants
Child Grade Elementary (1-4)	7 Participants n=22 Participants	6 Participants n=23 Participants	13 Participants n=45 Participants
Child Grade Middle (5-8)	9 Participants n=22 Participants	12 Participants n=23 Participants	21 Participants n=45 Participants
Child Grade High (9-12)	6 Participants n=22 Participants	5 Participants n=23 Participants	11 Participants n=45 Participants
Child Special Education Yes	4 Participants n=22 Participants	7 Participants n=23 Participants	11 Participants n=45 Participants
Child Special Education No	18 Participants n=22 Participants	16 Participants n=23 Participants	34 Participants n=45 Participants
Child Illness Comorbidity Yes	16 Participants n=22 Participants	11 Participants n=23 Participants	27 Participants n=45 Participants
Child Illness Comorbidity No	6 Participants n=22 Participants	12 Participants n=23 Participants	18 Participants n=45 Participants
Child Insurance Provider Medicaid	19 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	18 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	37 Participants n=42 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).
Child Insurance Provider Private	2 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	3 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	5 Participants n=42 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).
Child Insurance Provider None	0 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	0 Participants n=21 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).	0 Participants n=42 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures).
Asthma Control Test Above Clinical Cut Off (>19)	11 Participants n=22 Participants	7 Participants n=23 Participants	18 Participants n=45 Participants
Asthma Control Test Below Clinical Cut Off (>19)	11 Participants n=22 Participants	16 Participants n=23 Participants	27 Participants n=45 Participants
Forced Expiratory Volume (FEV)1	2.39 percentage of predicted FEV1 value STANDARD_DEVIATION 0.86 • n=18 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., equipment).	2.32 percentage of predicted FEV1 value STANDARD_DEVIATION 0.62 • n=15 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., equipment).	2.36 percentage of predicted FEV1 value STANDARD_DEVIATION 0.75 • n=33 Participants • The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., equipment).
Forced Expiratory Flow (FEF) 25-75	2.29 percent predicted STANDARD_DEVIATION 0.95 • n=22 Participants	2.26 percent predicted STANDARD_DEVIATION 0.68 • n=23 Participants	2.28 percent predicted STANDARD_DEVIATION 0.81 • n=45 Participants
The Asthma Action Plan Knowledge Interview (AAPKI)-Parent	72.72 Average percent correct STANDARD_DEVIATION 17.39 • n=22 Participants	71.50 Average percent correct STANDARD_DEVIATION 14.14 • n=23 Participants	72.10 Average percent correct STANDARD_DEVIATION 15.65 • n=45 Participants
The Asthma Action Plan Knowledge Interview (AAPKI)-Child	73.73 Average percent correct STANDARD_DEVIATION 17.67 • n=22 Participants	58.94 Average percent correct STANDARD_DEVIATION 19.66 • n=23 Participants	66.17 Average percent correct STANDARD_DEVIATION 19.95 • n=45 Participants
Wechsler Individual Achievement Test-III	97.14 age-based percentile rank STANDARD_DEVIATION 10.8 • n=22 Participants	95.22 age-based percentile rank STANDARD_DEVIATION 22 • n=23 Participants	96.16 age-based percentile rank STANDARD_DEVIATION 17.25 • n=45 Participants
Test of Functional Health Literacy in Adults (TOFHLA)	35 units on a scale n=22 Participants	35 units on a scale n=23 Participants	35 units on a scale n=45 Participants
Test of Functional Health Literacy (Child)	34.5 units on a scale n=8 Participants • The number of cases analyzed differed from the overall number analyzed due to some participants below age cutoff.	34 units on a scale n=10 Participants • The number of cases analyzed differed from the overall number analyzed due to some participants below age cutoff.	34 units on a scale n=18 Participants • The number of cases analyzed differed from the overall number analyzed due to some participants below age cutoff.
Asthma Numeracy Questionnaire	3.5 units on a scale n=22 Participants	4 units on a scale n=23 Participants	4 units on a scale n=45 Participants

PRIMARY outcome

Timeframe: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.

Population: The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., attrition, incomplete measures).

Outcome measures

Outcome measures
Measure	Pictorial Asthma Action Plan n=22 Participants 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. Pictorial Asthma Action Plan: 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 Plan n=23 Participants 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. Written Asthma Action Plan: 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.
The Asthma Action Plan Knowledge Interview (AAPKI)-Child 3 Month Assessment	76.11 Average Percent Correct Standard Error 20.16	61.40 Average Percent Correct Standard Error 11.33
The Asthma Action Plan Knowledge Interview (AAPKI)-Child 6 Month Assessment	77.08 Average Percent Correct Standard Error 17.90	62.09 Average Percent Correct Standard Error 11.15

PRIMARY outcome

Timeframe: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.

Population: The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., attrition, incomplete measures).

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.

Outcome measures

Outcome measures
Measure	Pictorial Asthma Action Plan n=22 Participants 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. Pictorial Asthma Action Plan: 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 Plan n=23 Participants 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. Written Asthma Action Plan: 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.
The Asthma Action Plan Knowledge Interview (AAPKI)-Parent 3 Month Assessment	74.44 Average Percent Correct Standard Deviation 16.95	69.59 Average Percent Correct Standard Deviation 13.78
The Asthma Action Plan Knowledge Interview (AAPKI)-Parent 6 Month Assessment	63.89 Average Percent Correct Standard Deviation 14.91	65.28 Average Percent Correct Standard Deviation 10.64

PRIMARY outcome

Timeframe: Measured at four time points over 6 months; baseline, 1-, 3- and 6-month follow-up.

Population: The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., attrition, incomplete measures).

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".

Outcome measures

Outcome measures
Measure	Pictorial Asthma Action Plan n=22 Participants 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. Pictorial Asthma Action Plan: 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 Plan n=23 Participants 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. Written Asthma Action Plan: 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.
Asthma Control Test 1 Month Assessment · Above ACT cut-off (>19)	19 Participants	11 Participants
Asthma Control Test 1 Month Assessment · Below ACT cut-off (>19)	3 Participants	11 Participants
Asthma Control Test 3 Month Assessment · Above ACT cut-off (>19)	17 Participants	16 Participants
Asthma Control Test 3 Month Assessment · Below ACT cut-off (>19)	3 Participants	3 Participants
Asthma Control Test 6 Month Assessment · Above ACT cut-off (>19)	12 Participants	13 Participants
Asthma Control Test 6 Month Assessment · Below ACT cut-off (>19)	4 Participants	4 Participants

PRIMARY outcome

Timeframe: Measured over 6 months; day 1, day 30, day 90 and day 180

Population: For this pilot program, prescription dose was not used for randomization into group. Only one participant had 1 puff per day; all other participants had 2 or 4. Thus, this participant taking only one per day was excluded from adherence analysis.

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.

Outcome measures

Outcome measures
Measure	Pictorial Asthma Action Plan n=21 Participants 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. Pictorial Asthma Action Plan: 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 Plan n=23 Participants 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. Written Asthma Action Plan: 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.
Adherence to Daily Controller Inhaler Day 1: 2x per day prescription	50 percentage of daily adherence Interval 50.0 to 100.0	75 percentage of daily adherence Interval 50.0 to 100.0
Adherence to Daily Controller Inhaler Day 1: 4x per day prescription	50 percentage of daily adherence Interval 50.0 to 75.0	50 percentage of daily adherence Interval 50.0 to 75.0
Adherence to Daily Controller Inhaler Day 30: 2x per day prescription	50 percentage of daily adherence Interval 50.0 to 100.0	100 percentage of daily adherence Interval 100.0 to 100.0
Adherence to Daily Controller Inhaler Day 30: 4x per day prescription	87.5 percentage of daily adherence Interval 50.0 to 100.0	50 percentage of daily adherence Interval 0.0 to 100.0
Adherence to Daily Controller Inhaler Day 90: 2x per day prescription	25 percentage of daily adherence Interval 0.0 to 100.0	0 percentage of daily adherence Interval 0.0 to 0.0
Adherence to Daily Controller Inhaler Day 90: 4x per day prescription	50 percentage of daily adherence Interval 0.0 to 75.0	25 percentage of daily adherence Interval 0.0 to 100.0

PRIMARY outcome

Timeframe: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.

Population: The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., equipment difficulties).

Lung function was assessed using spirometry outcome of Forced Expiratory Volume (FEV1),

Outcome measures

Outcome measures
Measure	Pictorial Asthma Action Plan n=22 Participants 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. Pictorial Asthma Action Plan: 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 Plan n=23 Participants 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. Written Asthma Action Plan: 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.
Lung Function-FEV1 3 Month Assessment	2.60 percentage of predicted FEV1 value Standard Deviation 1.07	2.39 percentage of predicted FEV1 value Standard Deviation 0.62
Lung Function-FEV1 6 Month Assessment	2.68 percentage of predicted FEV1 value Standard Deviation 0.98	2.66 percentage of predicted FEV1 value Standard Deviation 0.71

PRIMARY outcome

Timeframe: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.

Population: The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., equipment difficulties).

This data is gathered from a spirometry test. FEF 25-75 is the air flow between 25% and 75% of forced vital capacity.

Outcome measures

Outcome measures
Measure	Pictorial Asthma Action Plan n=22 Participants 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. Pictorial Asthma Action Plan: 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 Plan n=23 Participants 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. Written Asthma Action Plan: 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.
Lung Function- FEF 25-75 3 month	2.88 percent predicted Standard Deviation 1.14	2.58 percent predicted Standard Deviation 0.68
Lung Function- FEF 25-75 6 month	2.76 percent predicted Standard Deviation 1.45	2.61 percent predicted Standard Deviation 0.60

SECONDARY outcome

Timeframe: Measured at two time points over 6 months; 1- and 6-month follow-up.

Population: Pre-post analysis included combining 3 month and 6 month time points for outcome measures where the final time point was 3 instead of 6 months (N=6). The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., attrition, incomplete measures).

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.

Outcome measures

Outcome measures
Measure	Pictorial Asthma Action Plan n=22 Participants 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. Pictorial Asthma Action Plan: 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 Plan n=22 Participants 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. Written Asthma Action Plan: 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.
Satisfaction With Asthma Action Plan-Caregiver 1 Month Assessment	3.64 mean item score Standard Deviation 0.37	3.67 mean item score Standard Deviation 0.30
Satisfaction With Asthma Action Plan-Caregiver Final (combined 3 month/6 month)	3.60 mean item score Standard Deviation 0.35	3.68 mean item score Standard Deviation 0.30

SECONDARY outcome

Timeframe: Measured at two time points over 6 months; 1- and 6-month follow-up.

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.

Outcome measures

Outcome measures
Measure	Pictorial Asthma Action Plan n=22 Participants 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. Pictorial Asthma Action Plan: 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 Plan n=22 Participants 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. Written Asthma Action Plan: 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.
Satisfaction With Asthma Action Plan-Patient 1 Month Assessment	3.65 mean item score Standard Deviation 0.24	3.53 mean item score Standard Deviation 0.40
Satisfaction With Asthma Action Plan-Patient Combined 3 month/6 month	3.77 mean item score Standard Deviation 0.20	3.48 mean item score Standard Deviation 0.34

Adverse Events

Pictorial Asthma Action Plan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Written Asthma Action Plan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christina Duncan

West Virginia University

Phone: 304-293-1289

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place