Clinical trial NCT03187119: Investigation of the Role of Pictorial Asthma Action Plans to Promote Self-management in Rural Youth With Asthma
Official title: Take Action for Asthma Control Study - Pilot Randomized Controlled Trial of Pictorial Asthma Action Plans to Promote Self-management and Health in Rural Youth With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Pediatric
Education
Technology-supported intervention
Asthma Action Plan
Health literacy
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 45
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the potential benefit of Pictorial versus Written Asthma Action Plans (AAPs) to support asthma management among young people with persistent asthma. Participants will be randomly allocated to the Pictorial or Written AAP group and followed up over a 6-month period. Qualitative and quantitative data will be collected from young people, parents and clinical teams involved in recruitment to assess the feasibility and acceptability of the Pictorial AAP (PAAP) software developed for this study, the PAAPs produced by the software, and the study procedures.

Detailed description: Asthma is the most common chronic health condition of childhood, and continues to be associated with morbidity and mortality. Many children with persistent asthma follow a treatment plan including a prescription to take a daily inhaled corticosteroid (controller), often in conjunction with a daily oral controller medication, and a dose of an albuterol (rescue) inhaler before activity or exercise. Young people with asthma must add to this treatment plan in response to a flare in symptoms by taking additional medication and contacting their asthma provider or getting to a hospital. Adherence to daily medications is essential for maintaining lung health and reducing symptom flares, but asthma treatment is complex, requiring regular decision-making in response to symptoms and environmental issues like symptom triggers. As a result consistent adherence is a challenge for families and young people. It is recommended to provide an Asthma Action Plan (AAP) to all people diagnosed with asthma, summarizing their treatment plan using a traffic light format; Green Zone for daily, symptom-free management, Yellow Zone for symptom flare, and Red Zone for extreme symptom flare. Despite evidence for the effectiveness of AAPs, they are often not prescribed for reasons including readability and accessibility for families and young people, and asthma provider perceptions of their utility and suitability. In this study, young people with persistent asthma will be given a Written (WAAP) or Pictorial Asthma Action Plan (PAAP) to compare the differential impact on AAP knowledge, adherence to daily inhaler use, and asthma control. Software developed for the study, in collaboration with providers, young people with asthma and their parents, will be used to generate personalized PAAPs. Quantitative and qualitative data will be collected to explore perceptions of providers, parents and young people of different versions of AAPs, the influence of AAPs on asthma understanding and management, and the experience of taking part in the study, as well as to assess the impact of different AAPs on the asthma and psychosocial outcomes mentioned. The findings will inform the development of the PAAP software and as the basis for a definitive Randomized Controlled Trial of the efficacy of PAAPs.

Eligibility criteria: Inclusion Criteria:

* age 8-17 years
* new patient (to clinic) with a diagnosis of persistent asthma or an established patient with uncontrolled persistent asthma and a clinical need for a new treatment regimen
* no history of having received a written AAP
* prescribed an inhaled corticosteroid (i.e., daily controller medication).

Exclusion Criteria:

* patients and caregivers who do not use English as their primary language
* has a significant developmental (e.g., autism, intellectual disability) or sensory (e.g., blindness) disorder that would preclude completion of study measures.

Primary outcomes:
measure: The Asthma Action Plan Knowledge Interview (AAPKI)-Child
timeFrame: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
measure: The Asthma Action Plan Knowledge Interview (AAPKI)-Parent
timeFrame: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
measure: Asthma Control Test
timeFrame: Measured at four time points over 6 months; baseline, 1-, 3- and 6-month follow-up.
measure: Adherence to Daily Controller Inhaler
timeFrame: Measured over 6 months; day 1, day 30, day 90 and day 180
measure: Lung Function-FEV1
timeFrame: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
measure: Lung Function- FEF 25-75
timeFrame: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
Secondary outcomes:
measure: Satisfaction With Asthma Action Plan-Caregiver
timeFrame: Measured at two time points over 6 months; 1- and 6-month follow-up.
measure: Satisfaction With Asthma Action Plan-Patient
timeFrame: Measured at two time points over 6 months; 1- and 6-month follow-up.
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: WVU Medicine
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Christina Duncan, PhD
role: PRINCIPAL_INVESTIGATOR
References: