Asthma
Conditions
Keywords
Pediatric, Education, Technology-supported intervention, Asthma Action Plan, Health literacy
Brief 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. 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.
Interventions
BEHAVIORALPictorial 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.
BEHAVIORALWritten 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.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung Function- FEF 25-75 | 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. |
| Adherence to Daily Controller Inhaler | 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 | 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), |
| The Asthma Action Plan Knowledge Interview (AAPKI)-Child | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Asthma Action Plan-Patient | 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. |
| Satisfaction With Asthma Action Plan-Caregiver | 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. A mean item score was generated; higher scores indicate higher levels of satisfaction. Possible range of mean score was 0-4. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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. | 23 |
| Total | 45 |
Baseline characteristics
| Characteristic | Total | Pictorial Asthma Action Plan | Written Asthma Action Plan |
|---|---|---|---|
| Age, Categorical <=18 years | 45 Participants | 22 Participants | 23 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 11.79 years STANDARD_DEVIATION 2.75 | 11.70 years STANDARD_DEVIATION 2.91 | 11.87 years STANDARD_DEVIATION 2.65 |
| Annual Household Income 15,000 - $29,999 | 8 Participants | 2 Participants | 6 Participants |
| Annual Household Income $30,000 - $44,999 | 8 Participants | 5 Participants | 3 Participants |
| Annual Household Income $45,000 - $59,999 | 3 Participants | 2 Participants | 1 Participants |
| Annual Household Income $60,000 - $74,999 | 5 Participants | 1 Participants | 4 Participants |
| Annual Household Income $75,000 and greater | 15 Participants | 9 Participants | 6 Participants |
| Annual Household Income Less than $15,000 | 5 Participants | 3 Participants | 2 Participants |
| Asthma Control Test Above Clinical Cut Off (>19) | 18 Participants | 11 Participants | 7 Participants |
| Asthma Control Test Below Clinical Cut Off (>19) | 27 Participants | 11 Participants | 16 Participants |
| Asthma Numeracy Questionnaire | 4 units on a scale | 3.5 units on a scale | 4 units on a scale |
| Caregiver Age | 41.16 years STANDARD_DEVIATION 8.95 | 40.00 years STANDARD_DEVIATION 7.92 | 42.26 years STANDARD_DEVIATION 9.88 |
| Caregiver Marital Status Divorced / Single | 4 Participants | 0 Participants | 4 Participants |
| Caregiver Marital Status Living with boyfriend / girlfriend | 3 Participants | 1 Participants | 2 Participants |
| Caregiver Marital Status Married to other biological parent | 27 Participants | 14 Participants | 13 Participants |
| Caregiver Marital Status Never Been Married / Single | 2 Participants | 2 Participants | 0 Participants |
| Caregiver Marital Status Remarried to step-parent | 5 Participants | 3 Participants | 2 Participants |
| Caregiver Marital Status Widowed (other biological parent is deceased) | 1 Participants | 1 Participants | 0 Participants |
| Child Age of Diagnosis of Asthma | 5.67 years STANDARD_DEVIATION 4.07 | 3.94 years STANDARD_DEVIATION 2.93 | 7.30 years STANDARD_DEVIATION 1.38 |
| Child Extended Relatives Asthma No | 16 Participants | 9 Participants | 7 Participants |
| Child Extended Relatives Asthma Yes | 29 Participants | 13 Participants | 16 Participants |
| Child Grade Elementary (1-4) | 13 Participants | 7 Participants | 6 Participants |
| Child Grade High (9-12) | 11 Participants | 6 Participants | 5 Participants |
| Child Grade Middle (5-8) | 21 Participants | 9 Participants | 12 Participants |
| Child Illness Comorbidity No | 18 Participants | 6 Participants | 12 Participants |
| Child Illness Comorbidity Yes | 27 Participants | 16 Participants | 11 Participants |
| Child Immediate Relatives Asthma No | 17 Participants | 9 Participants | 8 Participants |
| Child Immediate Relatives Asthma Yes | 28 Participants | 13 Participants | 15 Participants |
| Child Insurance Provider Medicaid | 37 Participants | 19 Participants | 18 Participants |
| Child Insurance Provider None | 0 Participants | 0 Participants | 0 Participants |
| Child Insurance Provider Private | 5 Participants | 2 Participants | 3 Participants |
| Child Number of Relatives with Asthma Diagnosis No | 8 Participants | 4 Participants | 4 Participants |
| Child Number of Relatives with Asthma Diagnosis Yes | 37 Participants | 18 Participants | 19 Participants |
| Child Prior Diagnosis of Asthma No | 6 Participants | 2 Participants | 4 Participants |
| Child Prior Diagnosis of Asthma Yes | 39 Participants | 20 Participants | 19 Participants |
| Child Special Education No | 34 Participants | 18 Participants | 16 Participants |
| Child Special Education Yes | 11 Participants | 4 Participants | 7 Participants |
| Forced Expiratory Flow (FEF) 25-75 | 2.28 percent predicted STANDARD_DEVIATION 0.81 | 2.29 percent predicted STANDARD_DEVIATION 0.95 | 2.26 percent predicted STANDARD_DEVIATION 0.68 |
| Forced Expiratory Volume (FEV)1 | 2.36 percentage of predicted FEV1 value STANDARD_DEVIATION 0.75 | 2.39 percentage of predicted FEV1 value STANDARD_DEVIATION 0.86 | 2.32 percentage of predicted FEV1 value STANDARD_DEVIATION 0.62 |
| Parental Education Father Less than High School | 18 Participants | 7 Participants | 11 Participants |
| Parental Education Father More than High School | 27 Participants | 15 Participants | 12 Participants |
| Parental Education Mother Less than High School | 10 Participants | 3 Participants | 7 Participants |
| Parental Education Mother More than High School | 35 Participants | 19 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 43 Participants | 21 Participants | 22 Participants |
| Region of Enrollment United States | 45 participants | 22 participants | 23 participants |
| Sex: Female, Male Female | 27 Participants | 13 Participants | 14 Participants |
| Sex: Female, Male Male | 18 Participants | 9 Participants | 9 Participants |
| Test of Functional Health Literacy (Child) | 34 units on a scale | 34.5 units on a scale | 34 units on a scale |
| Test of Functional Health Literacy in Adults (TOFHLA) | 35 units on a scale | 35 units on a scale | 35 units on a scale |
| The Asthma Action Plan Knowledge Interview (AAPKI)-Child | 66.17 Average percent correct STANDARD_DEVIATION 19.95 | 73.73 Average percent correct STANDARD_DEVIATION 17.67 | 58.94 Average percent correct STANDARD_DEVIATION 19.66 |
| The Asthma Action Plan Knowledge Interview (AAPKI)-Parent | 72.10 Average percent correct STANDARD_DEVIATION 15.65 | 72.72 Average percent correct STANDARD_DEVIATION 17.39 | 71.50 Average percent correct STANDARD_DEVIATION 14.14 |
| Wechsler Individual Achievement Test-III | 96.16 age-based percentile rank STANDARD_DEVIATION 17.25 | 97.14 age-based percentile rank STANDARD_DEVIATION 10.8 | 95.22 age-based percentile rank STANDARD_DEVIATION 22 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 23 |
| other Total, other adverse events | 0 / 22 | 0 / 23 |
| serious Total, serious adverse events | 0 / 22 | 0 / 23 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pictorial Asthma Action Plan | Adherence to Daily Controller Inhaler | Day 90: 2x per day prescription | 25 percentage of daily adherence |
| Pictorial Asthma Action Plan | Adherence to Daily Controller Inhaler | Day 1: 2x per day prescription | 50 percentage of daily adherence |
| Pictorial Asthma Action Plan | Adherence to Daily Controller Inhaler | Day 1: 4x per day prescription | 50 percentage of daily adherence |
| Pictorial Asthma Action Plan | Adherence to Daily Controller Inhaler | Day 30: 2x per day prescription | 50 percentage of daily adherence |
| Pictorial Asthma Action Plan | Adherence to Daily Controller Inhaler | Day 30: 4x per day prescription | 87.5 percentage of daily adherence |
| Pictorial Asthma Action Plan | Adherence to Daily Controller Inhaler | Day 90: 4x per day prescription | 50 percentage of daily adherence |
| Written Asthma Action Plan | Adherence to Daily Controller Inhaler | Day 30: 4x per day prescription | 50 percentage of daily adherence |
| Written Asthma Action Plan | Adherence to Daily Controller Inhaler | Day 90: 2x per day prescription | 0 percentage of daily adherence |
| Written Asthma Action Plan | Adherence to Daily Controller Inhaler | Day 30: 2x per day prescription | 100 percentage of daily adherence |
| Written Asthma Action Plan | Adherence to Daily Controller Inhaler | Day 1: 2x per day prescription | 75 percentage of daily adherence |
| Written Asthma Action Plan | Adherence to Daily Controller Inhaler | Day 90: 4x per day prescription | 25 percentage of daily adherence |
| Written Asthma Action Plan | Adherence to Daily Controller Inhaler | Day 1: 4x per day prescription | 50 percentage of daily adherence |
Comparison: The reference group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.002generalized linear mixed model
Comparison: The reference group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.07generalized linear mixed model
Comparison: The reference group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.69generalized linear mixed model
Comparison: The reference group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.37generalized linear mixed model
Comparison: The reference group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.12generalized linear mixed model
Comparison: The reference groups for this analysis is the 2x per day group.p-value: 0.006generalized linear mixed model
Comparison: The reference group for this analysis is 2x per day group.p-value: 0.006generalized linear mixed model
Primary
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.
Time frame: 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).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pictorial Asthma Action Plan | Asthma Control Test | 1 Month Assessment | Below ACT cut-off (>19) | 3 Participants |
| Pictorial Asthma Action Plan | Asthma Control Test | 3 Month Assessment | Below ACT cut-off (>19) | 3 Participants |
| Pictorial Asthma Action Plan | Asthma Control Test | 6 Month Assessment | Above ACT cut-off (>19) | 12 Participants |
| Pictorial Asthma Action Plan | Asthma Control Test | 3 Month Assessment | Above ACT cut-off (>19) | 17 Participants |
| Pictorial Asthma Action Plan | Asthma Control Test | 6 Month Assessment | Below ACT cut-off (>19) | 4 Participants |
| Pictorial Asthma Action Plan | Asthma Control Test | 1 Month Assessment | Above ACT cut-off (>19) | 19 Participants |
| Written Asthma Action Plan | Asthma Control Test | 6 Month Assessment | Below ACT cut-off (>19) | 4 Participants |
| Written Asthma Action Plan | Asthma Control Test | 3 Month Assessment | Below ACT cut-off (>19) | 3 Participants |
| Written Asthma Action Plan | Asthma Control Test | 1 Month Assessment | Above ACT cut-off (>19) | 11 Participants |
| Written Asthma Action Plan | Asthma Control Test | 1 Month Assessment | Below ACT cut-off (>19) | 11 Participants |
| Written Asthma Action Plan | Asthma Control Test | 3 Month Assessment | Above ACT cut-off (>19) | 16 Participants |
| Written Asthma Action Plan | Asthma Control Test | 6 Month Assessment | Above ACT cut-off (>19) | 13 Participants |
Comparison: The reference for group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.06generalized linear mixed model
Comparison: The reference for group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.07generalized linear mixed model
Comparison: The reference for group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.33generalized linear mixed model
Primary
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pictorial Asthma Action Plan | Lung Function- FEF 25-75 | 3 month | 2.88 percent predicted | Standard Deviation 1.14 |
| Pictorial Asthma Action Plan | Lung Function- FEF 25-75 | 6 month | 2.76 percent predicted | Standard Deviation 1.45 |
| Written Asthma Action Plan | Lung Function- FEF 25-75 | 6 month | 2.61 percent predicted | Standard Deviation 0.6 |
| Written Asthma Action Plan | Lung Function- FEF 25-75 | 3 month | 2.58 percent predicted | Standard Deviation 0.68 |
Primary
Lung Function-FEV1
Lung function was assessed using spirometry outcome of Forced Expiratory Volume (FEV1),
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pictorial Asthma Action Plan | Lung Function-FEV1 | 3 Month Assessment | 2.60 percentage of predicted FEV1 value | Standard Deviation 1.07 |
| Pictorial Asthma Action Plan | Lung Function-FEV1 | 6 Month Assessment | 2.68 percentage of predicted FEV1 value | Standard Deviation 0.98 |
| Written Asthma Action Plan | Lung Function-FEV1 | 3 Month Assessment | 2.39 percentage of predicted FEV1 value | Standard Deviation 0.62 |
| Written Asthma Action Plan | Lung Function-FEV1 | 6 Month Assessment | 2.66 percentage of predicted FEV1 value | Standard Deviation 0.71 |
Comparison: The reference for group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.18multiple linear regression.
Comparison: The reference for group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.71multiple linear regression.
Comparison: The reference for group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.96multiple linear regression.
Primary
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pictorial Asthma Action Plan | The Asthma Action Plan Knowledge Interview (AAPKI)-Child | 3 Month Assessment | 76.11 Average Percent Correct | Standard Error 20.16 |
| Pictorial Asthma Action Plan | The Asthma Action Plan Knowledge Interview (AAPKI)-Child | 6 Month Assessment | 77.08 Average Percent Correct | Standard Error 17.9 |
| Written Asthma Action Plan | The Asthma Action Plan Knowledge Interview (AAPKI)-Child | 3 Month Assessment | 61.40 Average Percent Correct | Standard Error 11.33 |
| Written Asthma Action Plan | The Asthma Action Plan Knowledge Interview (AAPKI)-Child | 6 Month Assessment | 62.09 Average Percent Correct | Standard Error 11.15 |
Comparison: The reference group for this model is the Pictorial Asthma Action Plan Group.p-value: 0.42linear mixed model
Comparison: The reference group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.03multiple linear regression.
Comparison: The reference group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.89multiple linear regression.
Primary
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pictorial Asthma Action Plan | The Asthma Action Plan Knowledge Interview (AAPKI)-Parent | 3 Month Assessment | 74.44 Average Percent Correct | Standard Deviation 16.95 |
| Pictorial Asthma Action Plan | The Asthma Action Plan Knowledge Interview (AAPKI)-Parent | 6 Month Assessment | 63.89 Average Percent Correct | Standard Deviation 14.91 |
| Written Asthma Action Plan | The Asthma Action Plan Knowledge Interview (AAPKI)-Parent | 3 Month Assessment | 69.59 Average Percent Correct | Standard Deviation 13.78 |
| Written Asthma Action Plan | The Asthma Action Plan Knowledge Interview (AAPKI)-Parent | 6 Month Assessment | 65.28 Average Percent Correct | Standard Deviation 10.64 |
Comparison: The reference group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.31multiple linear regression.
Comparison: The reference for group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.73multiple linear regression.
Comparison: The reference for group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.92multiple linear regression.
Secondary
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pictorial Asthma Action Plan | Satisfaction With Asthma Action Plan-Caregiver | Final (combined 3 month/6 month) | 3.60 mean item score | Standard Deviation 0.35 |
| Pictorial Asthma Action Plan | Satisfaction With Asthma Action Plan-Caregiver | 1 Month Assessment | 3.64 mean item score | Standard Deviation 0.37 |
| Written Asthma Action Plan | Satisfaction With Asthma Action Plan-Caregiver | Final (combined 3 month/6 month) | 3.68 mean item score | Standard Deviation 0.3 |
| Written Asthma Action Plan | Satisfaction With Asthma Action Plan-Caregiver | 1 Month Assessment | 3.67 mean item score | Standard Deviation 0.3 |
Comparison: The reference for group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.74multiple linear regression.
Comparison: The reference for group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.83multiple linear regression.
Comparison: The reference for group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.03multiple linear regression.
Secondary
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pictorial Asthma Action Plan | Satisfaction With Asthma Action Plan-Patient | 1 Month Assessment | 3.65 mean item score | Standard Deviation 0.24 |
| Pictorial Asthma Action Plan | Satisfaction With Asthma Action Plan-Patient | Combined 3 month/6 month | 3.77 mean item score | Standard Deviation 0.2 |
| Written Asthma Action Plan | Satisfaction With Asthma Action Plan-Patient | 1 Month Assessment | 3.53 mean item score | Standard Deviation 0.4 |
| Written Asthma Action Plan | Satisfaction With Asthma Action Plan-Patient | Combined 3 month/6 month | 3.48 mean item score | Standard Deviation 0.34 |
Comparison: The reference for group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.08multiple linear regression.
Comparison: The reference for group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.25multiple linear regression.
Comparison: The reference for group for this analysis is the Pictorial Asthma Action Plan group.p-value: 0.03multiple linear regression.