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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-08-15

Brief Summary

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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.

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Detailed Description

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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

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Asthma in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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IMPACT Intervention

IMPACT health application and wearable device

Group Type EXPERIMENTAL

Improving Asthma Care Together (IMPACT)

Intervention Type BEHAVIORAL

IMPACT is a novel health application and wearable device

Usual care control

Usual care control.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Improving Asthma Care Together (IMPACT)

IMPACT is a novel health application and wearable device

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Clinician diagnosis of persistent asthma (prescription for daily asthma medication)
* Speak English

* 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

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

Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No