Skip to main content
OpenTrials
Completed

NCT Number: NCT04908384

Improving Asthma Care Together (IMPACT): A Shared Management Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma in Children

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington School of Nursing

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Improving Asthma Care Together (IMPACT)

Behavioral

IMPACT is a novel health application and wearable device

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Spirometry - FEV1/FVC Change From Baseline to 8 Weeks

    Time frame: 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.

  2. Spirometry - FEV1/FVC Change From 8 Weeks to 16 Weeks

    Time frame: 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.

  3. Childhood Asthma Control Test Change From Baseline to 8 Weeks

    Time frame: 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.

  4. Childhood Asthma Control Test Change From 8 Weeks to 16 Weeks

    Time frame: 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.

  5. Childhood Asthma Quality of Life Change From Baseline to 8 Weeks

    Time frame: 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.

  6. Childhood Asthma Quality of Life Change From 8 Weeks to 16 Weeks

    Time frame: 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.

  7. Parent Asthma Quality of Life Change From Baseline to 8 Weeks

    Time frame: 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.

  8. Parent Asthma Quality of Life Change From 8 Weeks to 16 Weeks

    Time frame: 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.

  9. Acceptability of Intervention Measure (Intervention Groups Only)

    Time frame: 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.

  10. Medication Adherence Change From Baseline to 8 Weeks

    Time frame: 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.

  11. Medication Adherence Change From 8 Weeks to 16 Weeks

    Time frame: 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.

  12. Feasibility of Intervention (Intervention Group Only)

    Time frame: 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.

  13. System Usability Scale (Intervention Group Only)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Improving Asthma Care Together (IMPACT): A Shared Management Pilot Study for Children With Asthma and Their Parents

Acronym: IMPACT

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 1, 2021
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.