MedDataX Logo

Investigation of the Role of Pictorial Asthma Action Plans to Promote Self-management in Rural Youth With Asthma

NCT ID: NCT03187119

Last Updated: 2021-10-22

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-24

Study Completion Date

2018-11-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pictorial Asthma Action Plan

Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP.

Group Type EXPERIMENTAL

Pictorial Asthma Action Plan

Intervention Type BEHAVIORAL

Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP.

Written Asthma Action Plan

Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP.

Group Type ACTIVE_COMPARATOR

Written Asthma Action Plan

Intervention Type BEHAVIORAL

Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pictorial Asthma Action Plan

Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP.

Intervention Type BEHAVIORAL

Written Asthma Action Plan

Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

West Virginia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christina Duncan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christina Duncan, PhD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

WVU Medicine

Morgantown, West Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1612396282

Identifier Type: -

Identifier Source: org_study_id