Clinical trial NCT04908384: Improving Asthma Care Together (IMPACT): A Shared Management Pilot Study
Official title: Improving Asthma Care Together (IMPACT): A Shared Management Pilot Study for Children With Asthma and Their Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Keywords: Self-management
Shared management
mHealth
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-06-01
Enrollment: 104
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Asthma Responsibility Questionnaire Change From 8 to 16 Weeks
timeFrame: 8 and 16 weeks
measure: Asthma Management Self-efficacy Change From Baseline to 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Asthma Management Self-efficacy Change From 8 Weeks to 16 Weeks
timeFrame: 8 and 16 weeks
Secondary outcomes:
measure: Spirometry - FEV1/FVC Change From Baseline to 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Spirometry - FEV1/FVC Change From 8 Weeks to 16 Weeks
timeFrame: 8 and 16 weeks
measure: Childhood Asthma Control Test Change From Baseline to 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Childhood Asthma Control Test Change From 8 Weeks to 16 Weeks
timeFrame: 8 and 16 weeks
measure: Childhood Asthma Quality of Life Change From Baseline to 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Childhood Asthma Quality of Life Change From 8 Weeks to 16 Weeks
timeFrame: 8 and 16 weeks
measure: Parent Asthma Quality of Life Change From Baseline to 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Parent Asthma Quality of Life Change From 8 Weeks to 16 Weeks
timeFrame: 8 and 16 weeks
measure: Acceptability of Intervention Measure (Intervention Groups Only)
timeFrame: 8 weeks
measure: Medication Adherence Change From Baseline to 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Medication Adherence Change From 8 Weeks to 16 Weeks
timeFrame: 8 and 16 weeks
measure: Feasibility of Intervention (Intervention Group Only)
timeFrame: 8 weeks
measure: System Usability Scale (Intervention Group Only)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington School of Nursing
state: Washington
Study officials:
affiliation: University of Washington
name: Jennifer T Sonney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.