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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR002317 | U.S. NIH Grant/Contract | View source | |
| 1R21NR019328 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMPACT Intervention | Experimental | IMPACT health application and wearable device |
|
| Usual care control | No Intervention | Usual care control. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Improving Asthma Care Together (IMPACT) | Behavioral | IMPACT is a novel health application and wearable device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 8 weeks |
| 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. | 8 and 16 weeks |
| 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. | Baseline and 8 weeks |
| 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. | 8 and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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CHILD Inclusion Criteria:
PARENT Inclusion Criteria:
CHILD Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer T Sonney, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington School of Nursing | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35144958 | Derived | Sonney J, Ward T, Thompson HJ, Kientz JA, Segrin C. Improving Asthma Care Together (IMPACT) mobile health intervention for school-age children with asthma and their parents: a pilot randomised controlled trial study protocol. BMJ Open. 2022 Feb 10;12(2):e059791. doi: 10.1136/bmjopen-2021-059791. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IMPACT Intervention Child Participants | IMPACT health application and wearable device - child participants Improving Asthma Care Together (IMPACT): IMPACT is a novel health application and wearable device |
| FG001 | IMPACT Intervention - Parent Participants | IMPACT health application and wearable device - parent participants Improving Asthma Care Together (IMPACT): IMPACT is a novel health application and wearable device |
| FG002 | Usual Care Control Child Participants | Usual care control - child participants |
| FG003 | Usual Care Control Parent Participants | Usual care control - parent participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IMPACT Intervention Child Participants | IMPACT health application and wearable device - child participants |
| BG001 | IMPACT Intervention Parent Participants | IMPACT health application and wearable device - parent participants |
| 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 | 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. | Posted | Mean | Standard Error | score on a scale | Baseline and 8 weeks |
|
During entire study period of 12 months
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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 | IMPACT Intervention - Child Participants | IMPACT health application and wearable device - child participants Improving Asthma Care Together (IMPACT): IMPACT is a novel health application and wearable device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Sonney | University of Washington | 206-685-2161 | jsonney@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2021 | Dec 4, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 19, 2020 | Dec 4, 2023 | SAP_001.pdf |
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| Baseline and 8 weeks |
| 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. | 8 and 16 weeks |
| 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. | Baseline and 8 weeks |
| 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. | 8 and 16 weeks |
| 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. | Baseline and 8 weeks |
| 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. | 8 and 16 weeks |
| 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. | Baseline and 8 weeks |
| 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. | 8 and 16 weeks |
| 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. | 8 weeks |
| 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. | Baseline and 8 weeks |
| 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. | 8 and 16 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| BG002 | Usual Care Control Child Participants | Usual care control - child participants |
| BG003 | Usual Care Control Parent Participants | Usual care control - parent participants |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Asthma Responsibility Questionnaire | 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. | Mean | Standard Deviation | units on a scale |
|
| Spirometry - FEV1/FVC | 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. | Only measured spirometry in child participants. | Mean | Standard Deviation | percent of predicted |
|
| Childhood asthma control test | 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. | Scale uses a combination of child and parent participants scores for an overall asthma control score. Overall scores reported under child participants. | Mean | Standard Deviation | units on a scale |
|
| Asthma Quality of Life | Self-report child (13 items)- or 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. | Mean | Standard Deviation | units on a scale |
|
| Medication Adherence | Medication Adherence Report Scale for Asthma, 10-items, 5-point scale assessing reported child asthma controller medication adherence at baseline. Baseline assessment of medication adherence allows for analyzing change in adherence following the study intervention. Higher adherence suggests better asthma management. Scores are averaged, ranging from 1-5, with higher scores indicating better adherence. | Mean | Standard Deviation | units on a scale |
|
| OG002 |
| Child Control Group |
Child participants assigned to control group |
| OG003 | Parent Control Group | Parent participants assigned to control group |
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | 8 and 16 weeks |
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | Baseline and 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | 8 and 16 weeks |
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|
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| 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. | Posted | Mean | Standard Error | percentage of predicted | Baseline and 8 weeks |
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| 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. | Posted | Mean | Standard Error | percentage of predicted | 8 and 16 weeks |
|
|
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| 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. | Scale uses a combination of child and parent participants scores for an overall asthma control score. Overall scores reported under child participants. | Posted | Mean | Standard Error | score on a scale | Baseline and 8 weeks |
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|
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| 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. | Scale uses a combination of child and parent participants scores for an overall asthma control score. Overall scores reported under child participants. | Posted | Mean | Standard Error | score on a scale | 8 and 16 weeks |
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | Baseline and 8 weeks |
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|
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| 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. | Posted | Mean | Standard Error | score on a scale | 8 and 16 weeks |
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| 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. | Means and SEs for this variable reflect an exponential transformation to compensate for a negatively skewed distribution in the raw variable. | Posted | Mean | Standard Error | score on a scale | Baseline and 8 weeks |
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|
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| 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. | Means and SEs for this variable reflect an exponential transformation to compensate for a negatively skewed distribution in the raw variable. | Posted | Mean | Standard Error | score on a scale | 8 and 16 weeks |
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|
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| 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. | Child max score of 10; parent max score of 20 | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| 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. | Posted | Mean | Standard Error | score on a scale | Baseline and 8 weeks |
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| 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. | Posted | Mean | Standard Error | score on a scale | 8 and 16 weeks |
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| 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. | child score max of 10; parent max score of 20 | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | IMPACT Intervention - Parent Participants | IMPACT health application and wearable device - parent participants Improving Asthma Care Together (IMPACT): IMPACT is a novel health application and wearable device | 0 | 21 | 0 | 21 | 0 | 21 |
| EG002 | Usual Care Control - Child Participants | Usual care control group - child participants | 0 | 31 | 0 | 31 | 0 | 31 |
| EG003 | Usual Care Control - Parent Participants | Usual care control group - parent participants | 0 | 31 | 0 | 31 | 0 | 31 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|