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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pictorial Asthma Action Plan | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 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". |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Duncan, PhD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WVU Medicine | Morgantown | West Virginia | 26501 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The analysis population is the same from the assignment in Participant Flow.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., attrition, incomplete measures). | Posted | Mean | Standard Error | Average Percent Correct | Measured at three time points over 6 months; baseline, 3- and 6-month follow-up. |
Adverse event data were collected over 1 year.
The definition of adverse event and/or serious adverse event used to collect adverse event information in this study did not differ from the clinicaltrials.gov definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christina Duncan | West Virginia University | 304-293-1289 | Christina.Duncan@mail.wvu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2017 | May 29, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Written Asthma Action Plan | Behavioral | 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. |
|
| 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 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 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 at three time points over 6 months; baseline, 3- and 6-month follow-up. |
| 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 at two time points over 6 months; 1- and 6-month follow-up. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Caregiver Age | Mean | Standard Deviation | years |
|
| Parental Education | Count of Participants | Participants |
|
| Caregiver Marital Status | The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures). | Count of Participants | Participants |
|
| Annual Household Income | The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures). | Count of Participants | Participants |
|
| Child Prior Diagnosis of Asthma | Count of Participants | Participants |
|
| Child Age of Diagnosis of Asthma | The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., equipment). | Mean | Standard Deviation | years |
|
| Child Number of Relatives with Asthma Diagnosis | Count of Participants | Participants |
|
| Child Immediate Relatives Asthma | Count of Participants | Participants |
|
| Child Extended Relatives Asthma | Count of Participants | Participants |
|
| Child Grade | Count of Participants | Participants |
|
| Child Special Education | Count of Participants | Participants |
|
| Child Illness Comorbidity | Count of Participants | Participants |
|
| Child Insurance Provider | The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., incomplete measures). | Count of Participants | Participants |
|
| Asthma Control Test | Asthma control was measures via the Asthma Control Test (ACT) 12 for participants 12 and older (Nathan et al., 2004), and the ACT 11 for participants 11 and younger (Liu et al., 2007). These scales include Likert type response options that differ by item, but for all items higher scores indicate more control. The raw scores were dichotomized for a clinical cut-off, with a score of 19 and less considered "poor control". | Count of Participants | Participants |
|
| Forced Expiratory Volume (FEV)1 | Lung function was assessed using spirometry outcome of Forced Expiratory Volume (FEV1). | The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., equipment). | Mean | Standard Deviation | percentage of predicted FEV1 value |
|
| Forced Expiratory Flow (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. | Mean | Standard Deviation | percent predicted |
|
| 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 that 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 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 for the nine questions. | Mean | Standard Deviation | Average percent correct |
|
| 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 that 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 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 for the nine questions. | Mean | Standard Deviation | Average percent correct |
|
| Wechsler Individual Achievement Test-III | Wechsler Individual Achievement Test-III (WIAT-III) - Reading Comprehension subtest. This subtest is a measure of reading comprehension that is widely validated for use in children and adolescents. Participants' raw score on the WIAT-III will be converted age-based percentile rank. | Mean | Standard Deviation | age-based percentile rank |
|
| Test of Functional Health Literacy in Adults (TOFHLA) | The Short Test of Functional Health Literacy in Adults (S-TOFHLA) is a measure of a respondent's ability to read and understand health-related information. Each item is scored 1 for correct and 0 for incorrect. There is a total of 36 items. Scores range from 0-36. Total raw scores < 16 are reflective of "inadequate" literacy. | Median | Inter-Quartile Range | units on a scale |
|
| Test of Functional Health Literacy (Child) | The Short Test of Functional Health Literacy in Adults (S-TOFHLA) is a measure of a respondent's ability to read and understand health-related information. Each item is scored 1 for correct and 0 for incorrect. There is a total of 36 items. Scores range from 0-36. Total raw scores < 16 are reflective of "inadequate" literacy. The measure was only administered to participants aged 13-17, as the measure has been validated in this age group, but not with younger children. | The number of cases analyzed differed from the overall number analyzed due to some participants below age cutoff. | Median | Inter-Quartile Range | units on a scale |
|
| Asthma Numeracy Questionnaire | The Asthma Numeracy Questionnaire (ANQ) assessed specific numerical skills used in asthma self-management. It is a 4-item questionnaire of numerical concepts (arithmetic and percentage) adapted from standard asthma education (Apter et al., 2006).The score is the number correct and ranges from 0 to 4. Lower scores indicate lower asthma numeracy. Higher scores indicates higher asthma numeracy. | Median | Inter-Quartile Range | units on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
| OG001 | 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. |
|
|
|
| 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. | The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., attrition, incomplete measures). | Posted | Mean | Standard Deviation | Average Percent Correct | Measured at three time points over 6 months; baseline, 3- and 6-month follow-up. |
|
|
|
|
| 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". | The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., attrition, incomplete measures). | Posted | Count of Participants | Participants | Measured at four time points over 6 months; baseline, 1-, 3- and 6-month follow-up. |
|
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | percentage of daily adherence | Measured over 6 months; day 1, day 30, day 90 and day 180 |
|
|
|
|
| Primary | Lung Function-FEV1 | Lung function was assessed using spirometry outcome of Forced Expiratory Volume (FEV1), | The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., equipment difficulties). | Posted | Mean | Standard Deviation | percentage of predicted FEV1 value | Measured at three time points over 6 months; baseline, 3- and 6-month follow-up. |
|
|
|
|
| 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. | The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., equipment difficulties). | Posted | Mean | Standard Deviation | percent predicted | Measured at three time points over 6 months; baseline, 3- and 6-month follow-up. |
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | mean item score | Measured at two time points over 6 months; 1- and 6-month follow-up. |
|
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | mean item score | Measured at two time points over 6 months; 1- and 6-month follow-up. |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | 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. | 0 | 23 | 0 | 23 | 0 | 23 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| More than High School |
|
| Living with boyfriend / girlfriend |
|
| Divorced / Single |
|
| Remarried to step-parent |
|
| Widowed (other biological parent is deceased) |
|
| $30,000 - $44,999 |
|
| $45,000 - $59,999 |
|
| $60,000 - $74,999 |
|
| $75,000 and greater |
|
| High (9-12) |
|
| None |
|
| 6 Month Assessment |
|
|
The reference for group for this analysis is the Pictorial Asthma Action Plan group. |
| multiple linear regression. |
| 0.73 |
The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction. |
| Slope |
| 1.90 |
| 2-Sided |
| Superiority |
| The reference for group for this analysis is the Pictorial Asthma Action Plan group. | multiple linear regression. | 0.92 | The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of group and time. | Slope | -0.21 | 2-Sided | Superiority |
| Below ACT cut-off (>19) |
|
| 3 Month Assessment |
|
|
| 6 Month Assessment |
|
|
The reference for group for this analysis is the Pictorial Asthma Action Plan group. |
| generalized linear mixed model |
| 0.07 |
The results listed here are for the main effect of group. Please see Analyses 1 and 2 for the main effect of group and the time x group interaction. |
| Slope |
| -1.57 |
| 2-Sided |
| Superiority |
| The reference for group for this analysis is the Pictorial Asthma Action Plan group. | generalized linear mixed model | 0.33 | The results listed here are for the time x group interaction. Please see Analyses 2 and 3 for the main effects of group and time. | Slope | 0.37 | 2-Sided | Superiority |
| Day 1: 4x per day prescription |
|
|
| Day 30: 2x per day prescription |
|
|
| Day 30: 4x per day prescription |
|
|
| Day 90: 2x per day prescription |
|
|
| Day 90: 4x per day prescription |
|
|
|
The reference group for this analysis is the Pictorial Asthma Action Plan group. |
| generalized linear mixed model |
| 0.07 |
The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effects of time and prescription and Analyses 4-6 for interactions. |
| Slope |
| -0.16 |
| 2-Sided |
The analyses are modeling lower adherence. |
| Superiority |
| The reference group for this analysis is the Pictorial Asthma Action Plan group. | generalized linear mixed model | .69 | The results listed here are for the main effect of prescription. Please see Analyses 1-2 for the main effects of time and group and Analyses 4-6 for interactions. | Slope | 0.43 | 2-Sided | The analyses are modeling lower adherence. | Superiority |
| The reference group for this analysis is the Pictorial Asthma Action Plan group. | generalized linear mixed model | 0.37 | The results listed here are for the time x group interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 5-7 for other interactions. | Slope | 0.02 | 2-Sided | The analyses are modeling lower adherence. | Superiority |
| The reference group for this analysis is the Pictorial Asthma Action Plan group. | generalized linear mixed model | 0.12 | The results listed here are for the prescription x group interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4 and 6 for other interactions. | Slope | -1.14 | 2-Sided | The analyses are modeling lower adherence. | Superiority |
| The reference groups for this analysis is the 2x per day group. | generalized linear mixed model | 0.006 | The results listed here are for the time x PAAP group x prescription interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4-5 for interactions. | Slope | 0.01 | 2-Sided | The analyses are modeling lower adherence. | Superiority |
| The reference group for this analysis is 2x per day group. | generalized linear mixed model | 0.006 | The results listed here are for the time x WAAP group x prescription interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4-5 for interactions. | Slope | 0.04 | 2-Sided | These analyses are modeling lower adherence. | Superiority |
| 6 Month Assessment |
|
|
The reference for group for this analysis is the Pictorial Asthma Action Plan group. |
| multiple linear regression. |
| 0.71 |
The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction. |
| Slope |
| -0.09 |
| 2-Sided |
| Superiority |
| The reference for group for this analysis is the Pictorial Asthma Action Plan group. | multiple linear regression. | 0.96 | The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group. | Slope | 0.007 | 2-Sided | Superiority |
| 6 month |
|
|
| Final (combined 3 month/6 month) |
|
|
The reference for group for this analysis is the Pictorial Asthma Action Plan group. |
| multiple linear regression. |
| 0.83 |
The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction |
| Slope |
| 0.02 |
| 2-Sided |
| Superiority |
| The reference for group for this analysis is the Pictorial Asthma Action Plan group. | multiple linear regression. | 0.03 | The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group. | Slope | -0.21 | 2-Sided | Superiority |
| Combined 3 month/6 month |
|
|
The reference for group for this analysis is the Pictorial Asthma Action Plan group. |
| multiple linear regression. |
| 0.25 |
The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction. |
| Slope |
| -0.12 |
| 2-Sided |
| Superiority |
| The reference for group for this analysis is the Pictorial Asthma Action Plan group. | multiple linear regression. | 0.03 | The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group. | Slope | -0.21 | 2-Sided | Superiority |