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

Asthma Clinical Trial

— TAAC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03187119
• Other study ID #: 1612396282
• Status: Completed
• Phase: N/A
• Start date: May 24, 2017
• Est. completion date: November 12, 2018

Study information

• Verified date: October 2021
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 12, 2018
• Est. primary completion date: November 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	WVU Medicine	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Asthma Action Plan Knowledge Interview (AAPKI)-Child	The Asthma Action Plan Knowledge Interview (AAPKI) was developed for the purposes of this study. The first section of the structured interview included 8 items describing hypothetical situations in which the respondent was asked to categorize themselves or their child into one of three zones. These items were scored as correct (1) or incorrect (0). Two items were excluded because they were not relevant to all participants. The second section of the structured interview included 3 open response items asking the respondent to describe the treatment instructions for the three zones according to the AAP. Responses were coded on a 4-point scale: 0 = incorrect; 1 = possibly correct, but vague or missing important details; 2 = correct but not detailed; 3 = correct and specific. Percent correct knowledge scores were calculated using six items from the first section and the three additional questions about treatment, for a total of nine questions.	Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
Primary	The Asthma Action Plan Knowledge Interview (AAPKI)-Parent	The Asthma Action Plan Knowledge Interview (AAPKI) was developed for the purposes of this study. The first section of the structured interview included 8 items describing hypothetical situations in which the respondent was asked to categorize their child into one of three zones. These items were scored as correct (1) or incorrect (0). Two items were excluded because they were not relevant to all participants. The second section of the structured interview included 3 open response items asking the respondent to describe the treatment instructions for the three zones according to the AAP. Responses were coded on a 4-point scale: 0 = incorrect; 1 = possibly correct, but vague or missing important details; 2 = correct but not detailed; 3 = correct and specific. Percent correct knowledge scores were calculated using six items from the first section and the three additional questions about treatment, for a total of nine questions.	Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
Primary	Asthma Control Test	Asthma control was measures via the Asthma Control Test (ACT) 12 for participants 12 and older (7 items), and the ACT 11 for participants 11 and younger (5 items). These scales include a 5 point Likert type response. Total score is calculated by summing response with higher scores indicating more control. Possible range of scores is 0-35. The raw scores were dichotomized for a clinical cut-off, with a score of 19 and less considered "poor control".	Measured at four time points over 6 months; baseline, 1-, 3- and 6-month follow-up.
Primary	Adherence to Daily Controller Inhaler	Adherence to daily controller inhaler measured objectively using an electronic monitor attached to the inhaler and connected to a smart phone application or 'hub' in the participant's home.Data was examined for daily percent adherence by comparing the number of puffs taken with the number of puffs prescribed. Day 180 was not included in the analyses due to low insufficient group size.	Measured over 6 months; day 1, day 30, day 90 and day 180
Primary	Lung Function-FEV1	Lung function was assessed using spirometry outcome of Forced Expiratory Volume (FEV1),	Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
Primary	Lung Function- FEF 25-75	This data is gathered from a spirometry test. FEF 25-75 is the air flow between 25% and 75% of forced vital capacity.	Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.
Secondary	Satisfaction With Asthma Action Plan-Caregiver	Satisfaction questions were developed for this project and a final questionnaire developed. The Satisfaction questionnaire was completed by both parents and children at post-test (1 month, and 3 or 6 months). The scale included 11 questions, 5 reverse coded, on a 4 point Likert-type response scale. A mean item score was generated; higher scores indicate higher levels of satisfaction. Possible range of mean score was 0-4.	Measured at two time points over 6 months; 1- and 6-month follow-up.
Secondary	Satisfaction With Asthma Action Plan-Patient	Satisfaction questions were developed for this project and a final questionnaire developed. The Satisfaction questionnaire was completed by both parents and children at post-test (1 month, and 3 or 6 months). The scale included 11 questions, 5 reverse coded, on a 4 point Likert-type response scale. Items were averaged together for a mean score; higher scores indicate higher levels of satisfaction. Possible range of mean score was 0-4.	Measured at two time points over 6 months; 1- and 6-month follow-up.