Asthma in ChildrenIMPACTNCT04908384
Improving Asthma Care Together (IMPACT): A Shared Management Pilot Study
A study testing Improving Asthma Care Together (IMPACT) in people with Asthma in Children, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Improving Asthma Care Together (IMPACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington School of Nursing
Seattle, Washington, 98195
About this study
Official title: Improving Asthma Care Together (IMPACT): A Shared Management Pilot Study for Children With Asthma and Their Parents
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.
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- Improving Asthma Care Together (IMPACT)
- Keywords
- Self-management, Shared management, mHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving Asthma Care Together (IMPACT)Behavioural
IMPACT is a novel health application and wearable device
| Study group | Role | What they receive |
|---|---|---|
| IMPACT Intervention | Experimental | IMPACT health application and wearable device Receives: Behavioral: Improving Asthma Care Together (IMPACT) |
| Usual care control | No intervention | Usual care control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 and 16 weeks
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Oct 2021
- Primary completion15 Dec 2022
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Jennifer Sonney, University of Washington
- Investigators
- Jennifer T Sonney, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908384
- Sponsor's protocol ID
- STUDY00010461
- Other IDs
- KL2TR002317, 1R21NR019328
- Acronym
- IMPACT
- Status last verified
- Jun 2024
- First submitted
- 29 Sep 2020
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steidl A, McHale J, Harmon S, Sonney J. Spirometry Monitoring and Asthma Responsibility in Kids (SMARt-Kids): A Mixed-Methods Study. J Pediatr Health Care. 2026 Jul 27:S0891-5245(26)00220-8. doi: 10.1016/j.pedhc.2026.06.014. Online ahead of print.
PubMed 42517830Sonney 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.
PubMed 35144958
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Asthma Care Together (IMPACT): A Shared Management Pilot Study for Children With Asthma and Their Parents
- ClinicalTrials.gov ID
- NCT04908384
- Acronym / sponsor ID
- IMPACT / STUDY00010461
- Conditions
- Asthma in Children
- Keywords
- Self-management, Shared management, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Posted 21 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMPACT Intervention | Experimental | Behavioral: Improving Asthma Care Together (IMPACT)IMPACT health application and wearable device |
| Usual care control | No intervention | –Usual care control. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improving Asthma Care Together (IMPACT)IMPACT is a novel health application and wearable device | Behavioural | IMPACT Intervention |
Primary outcome
Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
13 secondary outcomes
Spirometry - FEV1/FVC Change From Baseline to 8 Weeks
Time frame: Baseline and 8 weeks
Spirometry - FEV1/FVC Change From 8 Weeks to 16 Weeks
Time frame: 8 and 16 weeks
Childhood Asthma Control Test Change From Baseline to 8 Weeks
Time frame: Baseline and 8 weeks
Childhood Asthma Control Test Change From 8 Weeks to 16 Weeks
Time frame: 8 and 16 weeks
Childhood Asthma Quality of Life Change From Baseline to 8 Weeks
Time frame: Baseline and 8 weeks
Childhood Asthma Quality of Life Change From 8 Weeks to 16 Weeks
Time frame: 8 and 16 weeks
Parent Asthma Quality of Life Change From Baseline to 8 Weeks
Time frame: Baseline and 8 weeks
Parent Asthma Quality of Life Change From 8 Weeks to 16 Weeks
Time frame: 8 and 16 weeks
Acceptability of Intervention Measure (Intervention Groups Only)
Time frame: 8 weeks
Medication Adherence Change From Baseline to 8 Weeks
Time frame: Baseline and 8 weeks
Medication Adherence Change From 8 Weeks to 16 Weeks
Time frame: 8 and 16 weeks
Feasibility of Intervention (Intervention Group Only)
Time frame: 8 weeks
System Usability Scale (Intervention Group Only)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42517830Steidl A, McHale J, Harmon S, Sonney J. Spirometry Monitoring and Asthma Responsibility in Kids (SMARt-Kids): A Mixed-Methods Study. J Pediatr Health Care. 2026 Jul 27:S0891-5245(26)00220-8. doi: 10.1016/j.pedhc.2026.06.014. Online ahead of print.
- Derived from this study: PubMed 35144958Sonney 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer T Sonney, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improving Asthma Care Together (IMPACT) in people with Asthma in Children, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks (time frame: Baseline and 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04908384, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.