Asthma in Children
Conditions
Keywords
Self-management, Shared management, mHealth
Brief summary
This study aims to iteratively develop, refine and test the Improving Asthma Care Together (IMPACT) Intervention for school-age children (7-11 years) with persistent asthma and their parents.
Detailed description
Asthma is one of the most common chronic conditions of childhood, affecting over six million US children. Asthma treatment relies on self-management including symptom monitoring and response, trigger avoidance, and timely and appropriate medication use. Unfortunately, fewer than 50% of children with asthma are adherent to asthma treatment regimens, leading to increased disease morbidity and mortality and potentially irreversible airway damage. Children with asthma are missing a voice in their own care. The school-age years (7-11) represent a natural transition in asthma management, as children must assume some responsibility for asthma-related care while they spend increasing time away from parents at school and other extracurricular activities. Yet, existing interventions focus on parents alone and use prescriptive approaches, telling the parent what to do to the child to manage their asthma. As a result, current strategies are failing to provide children with asthma and their families the tools they need to manage asthma successfully within the realities of their daily lives. Using a Human-Centered Design (HCD) framework, the investigators co-designed a tailored asthma shared management mobile health application that pairs the parent and child together as a team and facilitates the intentional transition of some asthma management to the child. The hypothesis is that by involving children in their own care, participants will improve asthma management in the present, but also establish lifelong successful self-management skills. The objective of the proposed study is to pilot test the Improving Asthma Care Together (IMPACT) mobile health application with parent-child dyads. Based on the preliminary data, the central hypothesis is that IMPACT will be effective for delivering a shared asthma management intervention for children and their parents.
Interventions
BEHAVIORALImproving Asthma Care Together (IMPACT)
IMPACT is a novel health application and wearable device
Sponsors
National Institute of Nursing Research (NINR)
National Center for Advancing Translational Sciences (NCATS)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
CHILD Inclusion Criteria: * Clinician diagnosis of persistent asthma (prescription for daily asthma medication) * Speak English PARENT Inclusion Criteria: * 18 years or older * Child's primary caregiver * Able to understand and read English * Reside with the child 50% or more * Legal guardian who can consent for child to participate * Have access to a smart phone and reliable home internet access * Reported Asthma Responsibility Questionnaire score \< or = 2.5 at screening CHILD
Exclusion criteria
* Parent report of developmental delay (language \< 5 year level) * Co-morbid cancer, diabetes, attention deficit hyperactivity disorder (ADHD) * Current asthma exacerbation at the time of recruitment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks | Baseline and 8 weeks | 10- items, 5-point scale to report asthma management task responsibility. Total score is the mean of all items calculated. Scores range from 1 to 5, with 1= parent takes responsibility all of the time, 3= parent and child share responsibility about equally, and 5 = child takes responsibility all of the time. |
| Asthma Responsibility Questionnaire Change From 8 to 16 Weeks | 8 and 16 weeks | 10- items, 5-point scale to report asthma management task responsibility. Total score is the mean of all items calculated. Scores range from 1 to 5, with 1= parent takes responsibility all of the time, 3= parent and child share responsibility about equally, and 5 = child takes responsibility all of the time. |
| Asthma Management Self-efficacy Change From Baseline to 8 Weeks | Baseline and 8 weeks | 13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy. Scores are averaged with higher scores indicate higher self-efficacy. Possible range of 1-5. |
| Asthma Management Self-efficacy Change From 8 Weeks to 16 Weeks | 8 and 16 weeks | 13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy. Scores are averaged and higher scores indicate higher self-efficacy. Possible score range of 1-5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Childhood Asthma Quality of Life Change From Baseline to 8 Weeks | Baseline and 8 weeks | Self-report child (13 items)- asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Possible score range of 1-7. |
| Childhood Asthma Quality of Life Change From 8 Weeks to 16 Weeks | 8 and 16 weeks | Self-report child (13 items)- asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Possible score range of 1-7. |
| Parent Asthma Quality of Life Change From Baseline to 8 Weeks | Baseline and 8 weeks | Parent/caregiver (13 items)-reported asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Score range of variable, which required exponential transformation for negatively skewed distribution, was 2.72-43.35, with higher scores indicating worse quality of life. |
| Parent Asthma Quality of Life Change From 8 Weeks to 16 Weeks | 8 and 16 weeks | Parent/caregiver (13 items)-reported asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Score range of variable, which required exponential transformation for negatively skewed distribution, was 2.72-345.90, with higher scores indicating worse quality of life. |
| Spirometry - FEV1/FVC Change From Baseline to 8 Weeks | Baseline and 8 weeks | Spirometry - objective measure of expiratory lung function will be used to evaluate asthma control. Specifically, the forced expiratory volume in one second/forced vital capacity (FEV1/FVC) measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report). Scores are presented as a percentage and typically range from 1% to 120% (occasionally higher), with higher scores indicating better asthma control. Note, national asthma guidelines consider \>85% to indicate well controlled asthma. |
| Medication Adherence Change From Baseline to 8 Weeks | Baseline and 8 weeks | Medication Adherence Report Scale for Asthma, 10-items, 5-point scale assessing reported child asthma controller medication adherence at baseline and throughout the study. Higher adherence suggests better asthma management. Scores are averaged, ranging from 1-5, with higher scores indicating better adherence. |
| Medication Adherence Change From 8 Weeks to 16 Weeks | 8 and 16 weeks | Medication Adherence Report Scale for Asthma, 10-items, 5-point scale assessing reported child asthma controller medication adherence at baseline and throughout the study. Higher adherence suggests better asthma management. Scores are averaged, ranging from 1-5, with higher scores indicating better adherence. |
| Feasibility of Intervention (Intervention Group Only) | 8 weeks | 4 items (2 for children) using 5-point scale; scores are summed with higher scores indicate higher feasibility. Possible score range of 4-20 for parents, 2-10 for children. |
| System Usability Scale (Intervention Group Only) | 8 weeks | System usability scale - 10 items, 5-point scale to determine perceived usability of a system. To calculate the SUS score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of SU. Total score may range from 0 to 100 with higher scores indicating higher usability. Used only post-intervention. |
| Acceptability of Intervention Measure (Intervention Groups Only) | 8 weeks | 4 items (2 for children) using 5-point scale; scores are summed with higher scores indicate higher acceptability. Possible score range of 4-20 for parents, 2-10 for children. |
| Spirometry - FEV1/FVC Change From 8 Weeks to 16 Weeks | 8 and 16 weeks | Spirometry - objective measure of expiratory lung function will be used to evaluate asthma control. Specifically, the forced expiratory volume in one second/forced vital capacity (FEV1/FVC) measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report). Scores are presented as a percentage and typically range from 1% to 120% (occasionally higher), with higher scores indicating better asthma control. Note, national asthma guidelines consider \>85% to indicate well controlled asthma. |
| Childhood Asthma Control Test Change From Baseline to 8 Weeks | Baseline and 8 weeks | 7 total items--3 parent (5-point scale) and 4 child (3-point scale) to assess asthma control. Parent and child scores are summed, possible range of 7-27, with higher scores indicate better control. One total score reported for child participants. |
| Childhood Asthma Control Test Change From 8 Weeks to 16 Weeks | 8 and 16 weeks | 7 total items--3 parent (5-point scale) and 4 child (3-point scale) to assess asthma control. Parent and child scores are summed, possible range of 7-27, with higher scores indicate better control. One total score reported for child participants. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IMPACT Intervention Child Participants IMPACT health application and wearable device - child participants | 21 |
| IMPACT Intervention Parent Participants IMPACT health application and wearable device - parent participants | 21 |
| Usual Care Control Child Participants Usual care control - child participants | 31 |
| Usual Care Control Parent Participants Usual care control - parent participants | 31 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 4 | 0 | 0 |
Baseline characteristics
| Characteristic | IMPACT Intervention Child Participants | Usual Care Control Parent Participants | IMPACT Intervention Parent Participants | Usual Care Control Child Participants | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 21 Participants | 0 Participants | 0 Participants | 31 Participants | 52 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 31 Participants | 21 Participants | 0 Participants | 52 Participants |
| Asthma Quality of Life | 5.67 units on a scale STANDARD_DEVIATION 0.99 | 5.8 units on a scale STANDARD_DEVIATION 0.85 | 5.6 units on a scale STANDARD_DEVIATION 0.95 | 5.88 units on a scale STANDARD_DEVIATION 0.57 | 5.7 units on a scale STANDARD_DEVIATION 0.61 |
| Asthma Responsibility Questionnaire | 2.74 units on a scale STANDARD_DEVIATION 0.55 | 2.3 units on a scale STANDARD_DEVIATION 0.7 | 2.4 units on a scale STANDARD_DEVIATION 0.61 | 2.69 units on a scale STANDARD_DEVIATION 0.54 | 2.5 units on a scale STANDARD_DEVIATION 0.51 |
| Childhood asthma control test | 19.8 units on a scale STANDARD_DEVIATION 3.19 | — | — | 21.39 units on a scale STANDARD_DEVIATION 2.65 | 20.8 units on a scale STANDARD_DEVIATION 2.96 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 6 Participants | 4 Participants | 6 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 25 Participants | 17 Participants | 25 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Medication Adherence | 3.7 units on a scale STANDARD_DEVIATION 0.78 | 4.0 units on a scale STANDARD_DEVIATION 0.62 | 4.1 units on a scale STANDARD_DEVIATION 0.79 | 3.8 units on a scale STANDARD_DEVIATION 0.75 | 3.9 units on a scale STANDARD_DEVIATION 0.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 1 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 3 Participants | 1 Participants | 7 Participants | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 9 Participants | 17 Participants | 14 Participants | 15 Participants | 55 Participants |
| Sex: Female, Male Female | 10 Participants | 29 Participants | 20 Participants | 17 Participants | 76 Participants |
| Sex: Female, Male Male | 11 Participants | 2 Participants | 1 Participants | 14 Participants | 28 Participants |
| Spirometry - FEV1/FVC | 85.7 percent of predicted STANDARD_DEVIATION 10.5 | — | — | 78.6 percent of predicted STANDARD_DEVIATION 13.4 | 82.9 percent of predicted STANDARD_DEVIATION 12.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 | 0 / 31 | 0 / 31 |
| other Total, other adverse events | 0 / 21 | 0 / 21 | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 | 0 / 31 | 0 / 31 |
Outcome results
Primary
Asthma Management Self-efficacy Change From 8 Weeks to 16 Weeks
13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy. Scores are averaged and higher scores indicate higher self-efficacy. Possible score range of 1-5.
Time frame: 8 and 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Asthma Management Self-efficacy Change From 8 Weeks to 16 Weeks | 3.69 score on a scale | Standard Error 0.12 |
| Parent Intervention Group | Asthma Management Self-efficacy Change From 8 Weeks to 16 Weeks | 4.36 score on a scale | Standard Error 0.1 |
| Child Control Group | Asthma Management Self-efficacy Change From 8 Weeks to 16 Weeks | 3.49 score on a scale | Standard Error 0.09 |
| Parent Control Group | Asthma Management Self-efficacy Change From 8 Weeks to 16 Weeks | 4.52 score on a scale | Standard Error 0.08 |
Primary
Asthma Management Self-efficacy Change From Baseline to 8 Weeks
13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy. Scores are averaged with higher scores indicate higher self-efficacy. Possible range of 1-5.
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Asthma Management Self-efficacy Change From Baseline to 8 Weeks | 3.79 score on a scale | Standard Error 0.11 |
| Parent Intervention Group | Asthma Management Self-efficacy Change From Baseline to 8 Weeks | 4.27 score on a scale | Standard Error 0.09 |
| Child Control Group | Asthma Management Self-efficacy Change From Baseline to 8 Weeks | 3.74 score on a scale | Standard Error 0.08 |
| Parent Control Group | Asthma Management Self-efficacy Change From Baseline to 8 Weeks | 4.41 score on a scale | Standard Error 0.07 |
Primary
Asthma Responsibility Questionnaire Change From 8 to 16 Weeks
10- items, 5-point scale to report asthma management task responsibility. Total score is the mean of all items calculated. Scores range from 1 to 5, with 1= parent takes responsibility all of the time, 3= parent and child share responsibility about equally, and 5 = child takes responsibility all of the time.
Time frame: 8 and 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Asthma Responsibility Questionnaire Change From 8 to 16 Weeks | 2.88 score on a scale | Standard Error 0.13 |
| Parent Intervention Group | Asthma Responsibility Questionnaire Change From 8 to 16 Weeks | 2.63 score on a scale | Standard Error 0.13 |
| Child Control Group | Asthma Responsibility Questionnaire Change From 8 to 16 Weeks | 2.90 score on a scale | Standard Error 0.1 |
| Parent Control Group | Asthma Responsibility Questionnaire Change From 8 to 16 Weeks | 2.4 score on a scale | Standard Error 0.1 |
Primary
Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks
10- items, 5-point scale to report asthma management task responsibility. Total score is the mean of all items calculated. Scores range from 1 to 5, with 1= parent takes responsibility all of the time, 3= parent and child share responsibility about equally, and 5 = child takes responsibility all of the time.
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks | 2.72 score on a scale | Standard Error 0.14 |
| Parent Intervention Group | Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks | 2.72 score on a scale | Standard Error 0.11 |
| Child Control Group | Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks | 2.79 score on a scale | Standard Error 0.1 |
| Parent Control Group | Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks | 2.31 score on a scale | Standard Error 0.08 |
Secondary
Acceptability of Intervention Measure (Intervention Groups Only)
4 items (2 for children) using 5-point scale; scores are summed with higher scores indicate higher acceptability. Possible score range of 4-20 for parents, 2-10 for children.
Time frame: 8 weeks
Population: Child max score of 10; parent max score of 20
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Acceptability of Intervention Measure (Intervention Groups Only) | 8 score on a scale | Standard Deviation 1.26 |
| Parent Intervention Group | Acceptability of Intervention Measure (Intervention Groups Only) | 14.42 score on a scale | Standard Deviation 3.62 |
Secondary
Childhood Asthma Control Test Change From 8 Weeks to 16 Weeks
7 total items--3 parent (5-point scale) and 4 child (3-point scale) to assess asthma control. Parent and child scores are summed, possible range of 7-27, with higher scores indicate better control. One total score reported for child participants.
Time frame: 8 and 16 weeks
Population: Scale uses a combination of child and parent participants scores for an overall asthma control score. Overall scores reported under child participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Childhood Asthma Control Test Change From 8 Weeks to 16 Weeks | 12.93 score on a scale | Standard Error 0.58 |
| Parent Intervention Group | Childhood Asthma Control Test Change From 8 Weeks to 16 Weeks | 12.14 score on a scale | Standard Error 0.43 |
Secondary
Childhood Asthma Control Test Change From Baseline to 8 Weeks
7 total items--3 parent (5-point scale) and 4 child (3-point scale) to assess asthma control. Parent and child scores are summed, possible range of 7-27, with higher scores indicate better control. One total score reported for child participants.
Time frame: Baseline and 8 weeks
Population: Scale uses a combination of child and parent participants scores for an overall asthma control score. Overall scores reported under child participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Childhood Asthma Control Test Change From Baseline to 8 Weeks | 12.46 score on a scale | Standard Error 0.37 |
| Parent Intervention Group | Childhood Asthma Control Test Change From Baseline to 8 Weeks | 12.78 score on a scale | Standard Error 0.28 |
Secondary
Childhood Asthma Quality of Life Change From 8 Weeks to 16 Weeks
Self-report child (13 items)- asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Possible score range of 1-7.
Time frame: 8 and 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Childhood Asthma Quality of Life Change From 8 Weeks to 16 Weeks | 5.56 score on a scale | Standard Error 0.16 |
| Parent Intervention Group | Childhood Asthma Quality of Life Change From 8 Weeks to 16 Weeks | 5.98 score on a scale | Standard Error 0.12 |
Secondary
Childhood Asthma Quality of Life Change From Baseline to 8 Weeks
Self-report child (13 items)- asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Possible score range of 1-7.
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Childhood Asthma Quality of Life Change From Baseline to 8 Weeks | 5.74 score on a scale | Standard Error 0.15 |
| Parent Intervention Group | Childhood Asthma Quality of Life Change From Baseline to 8 Weeks | 5.97 score on a scale | Standard Error 0.11 |
Secondary
Feasibility of Intervention (Intervention Group Only)
4 items (2 for children) using 5-point scale; scores are summed with higher scores indicate higher feasibility. Possible score range of 4-20 for parents, 2-10 for children.
Time frame: 8 weeks
Population: child score max of 10; parent max score of 20
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Feasibility of Intervention (Intervention Group Only) | 8 score on a scale | Standard Deviation 1.17 |
| Parent Intervention Group | Feasibility of Intervention (Intervention Group Only) | 14.37 score on a scale | Standard Deviation 3.36 |
Secondary
Medication Adherence Change From 8 Weeks to 16 Weeks
Medication Adherence Report Scale for Asthma, 10-items, 5-point scale assessing reported child asthma controller medication adherence at baseline and throughout the study. Higher adherence suggests better asthma management. Scores are averaged, ranging from 1-5, with higher scores indicating better adherence.
Time frame: 8 and 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Medication Adherence Change From 8 Weeks to 16 Weeks | 3.32 score on a scale | Standard Error 0.65 |
| Parent Intervention Group | Medication Adherence Change From 8 Weeks to 16 Weeks | 3.04 score on a scale | Standard Error 0.45 |
| Child Control Group | Medication Adherence Change From 8 Weeks to 16 Weeks | 3.78 score on a scale | Standard Error 0.48 |
| Parent Control Group | Medication Adherence Change From 8 Weeks to 16 Weeks | 3.65 score on a scale | Standard Error 0.33 |
Secondary
Medication Adherence Change From Baseline to 8 Weeks
Medication Adherence Report Scale for Asthma, 10-items, 5-point scale assessing reported child asthma controller medication adherence at baseline and throughout the study. Higher adherence suggests better asthma management. Scores are averaged, ranging from 1-5, with higher scores indicating better adherence.
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Medication Adherence Change From Baseline to 8 Weeks | 3.20 score on a scale | Standard Error 0.53 |
| Parent Intervention Group | Medication Adherence Change From Baseline to 8 Weeks | 3.30 score on a scale | Standard Error 0.44 |
| Child Control Group | Medication Adherence Change From Baseline to 8 Weeks | 3.70 score on a scale | Standard Error 0.39 |
| Parent Control Group | Medication Adherence Change From Baseline to 8 Weeks | 3.25 score on a scale | Standard Error 0.32 |
Secondary
Parent Asthma Quality of Life Change From 8 Weeks to 16 Weeks
Parent/caregiver (13 items)-reported asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Score range of variable, which required exponential transformation for negatively skewed distribution, was 2.72-345.90, with higher scores indicating worse quality of life.
Time frame: 8 and 16 weeks
Population: Means and SEs for this variable reflect an exponential transformation to compensate for a negatively skewed distribution in the raw variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Parent Asthma Quality of Life Change From 8 Weeks to 16 Weeks | 12.85 score on a scale | Standard Error 3.29 |
| Parent Intervention Group | Parent Asthma Quality of Life Change From 8 Weeks to 16 Weeks | 17.44 score on a scale | Standard Error 10.99 |
Secondary
Parent Asthma Quality of Life Change From Baseline to 8 Weeks
Parent/caregiver (13 items)-reported asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Score range of variable, which required exponential transformation for negatively skewed distribution, was 2.72-43.35, with higher scores indicating worse quality of life.
Time frame: Baseline and 8 weeks
Population: Means and SEs for this variable reflect an exponential transformation to compensate for a negatively skewed distribution in the raw variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Parent Asthma Quality of Life Change From Baseline to 8 Weeks | 11.56 score on a scale | Standard Error 2.7 |
| Parent Intervention Group | Parent Asthma Quality of Life Change From Baseline to 8 Weeks | 7.08 score on a scale | Standard Error 1.27 |
Secondary
Spirometry - FEV1/FVC Change From 8 Weeks to 16 Weeks
Spirometry - objective measure of expiratory lung function will be used to evaluate asthma control. Specifically, the forced expiratory volume in one second/forced vital capacity (FEV1/FVC) measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report). Scores are presented as a percentage and typically range from 1% to 120% (occasionally higher), with higher scores indicating better asthma control. Note, national asthma guidelines consider \>85% to indicate well controlled asthma.
Time frame: 8 and 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Spirometry - FEV1/FVC Change From 8 Weeks to 16 Weeks | 85.38 percentage of predicted | Standard Error 2.42 |
| Parent Intervention Group | Spirometry - FEV1/FVC Change From 8 Weeks to 16 Weeks | 81.82 percentage of predicted | Standard Error 1.73 |
Secondary
Spirometry - FEV1/FVC Change From Baseline to 8 Weeks
Spirometry - objective measure of expiratory lung function will be used to evaluate asthma control. Specifically, the forced expiratory volume in one second/forced vital capacity (FEV1/FVC) measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report). Scores are presented as a percentage and typically range from 1% to 120% (occasionally higher), with higher scores indicating better asthma control. Note, national asthma guidelines consider \>85% to indicate well controlled asthma.
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | Spirometry - FEV1/FVC Change From Baseline to 8 Weeks | 85.18 percentage of predicted | Standard Error 3.35 |
| Parent Intervention Group | Spirometry - FEV1/FVC Change From Baseline to 8 Weeks | 82.87 percentage of predicted | Standard Error 2.39 |
Secondary
System Usability Scale (Intervention Group Only)
System usability scale - 10 items, 5-point scale to determine perceived usability of a system. To calculate the SUS score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of SU. Total score may range from 0 to 100 with higher scores indicating higher usability. Used only post-intervention.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Child Intervention Group | System Usability Scale (Intervention Group Only) | 68.95 score on a scale | Standard Deviation 14.03 |
| Parent Intervention Group | System Usability Scale (Intervention Group Only) | 62.5 score on a scale | Standard Deviation 19.18 |