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

NCT03187119 | Completed Results DMC

• 1 other identifier: 1612396282
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Pediatric; Education; Technology-supported intervention; Asthma Action Plan; Health literacy

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

• 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.

• 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

• 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.

• 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 Outcomes (2)

• Satisfaction With Asthma Action Plan-Caregiver

  Measured at two time points over 6 months; 1- and 6-month follow-up.

• Satisfaction With Asthma Action Plan-Patient

  Measured at two time points over 6 months; 1- and 6-month follow-up.

Study Arms (2)

Pictorial Asthma Action Plan

EXPERIMENTAL

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.

Behavioral: Pictorial Asthma Action Plan

Written Asthma Action Plan

ACTIVE COMPARATOR

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.

Behavioral: Written Asthma Action Plan

Interventions

Pictorial Asthma Action Plan 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.

Pictorial Asthma Action Plan

Written Asthma Action Plan 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.

Written Asthma Action Plan

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

WVU Medicine

Morgantown, West Virginia, 26501, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Christina Duncan
• Organization: West Virginia University

Christina.Duncan@mail.wvu.edu

304-293-1289

Study Officials

• Christina Duncan, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 14, 2017
• Study Start: May 24, 2017
• Primary Completion: November 12, 2018
• Study Completion: November 12, 2018
• Last Updated: October 22, 2021
• Results First Posted: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)