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

University of Washington

Status: Completed

Conditions: Asthma in Children

Treatments: Behavioral: Improving Asthma Care Together (IMPACT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04908384

KL2TR002317 (U.S. NIH Grant/Contract)

1R21NR019328 (U.S. NIH Grant/Contract)

STUDY00010461

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 7 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

104 participants in 2 patient groups

IMPACT Intervention

Experimental group

Description:

IMPACT health application and wearable device

Treatment:

Behavioral: Improving Asthma Care Together (IMPACT)

Usual care control

No Intervention group

Description:

Usual care control.