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

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ClinicalTrials.gov Identifier: NCT03187119
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Christina Duncan, West Virginia University

Tracking Information
First Submitted Date  ICMJE June 7, 2017
First Posted Date  ICMJE June 14, 2017
Last Update Posted Date April 30, 2019
Actual Study Start Date  ICMJE May 24, 2017
Actual Primary Completion Date November 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2017)
  • Change in Asthma Action Plan Knowledge [ Time Frame: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up. ]
    Knowledge of Asthma Action Plan assessed using a survey developed for the study.
  • Change in Asthma Control Test scores [ Time Frame: Measured at four time points over 6 months; baseline, 1-, 3- and 6-month follow-up. ]
    Control of asthma symptoms and burden assessed using the Asthma Control Test.
  • Change in adherence to daily controller inhaler [ Time Frame: Measured at four time points over 6 months; baseline, 1-, 3- and 6-month follow-up. ]
    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.
  • Change in lung function [ Time Frame: Measured at three time points over 6 months; baseline, 3- and 6-month follow-up. ]
    Lung function measured using Spirometry.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03187119 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2017)
Satisfaction with Asthma Action Plan [ Time Frame: Measured at two time points over 6 months; 1- and 6-month follow-up. ]
Satisfaction with Asthma Action Plan measured using a survey developed for this study.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 12, 2017)
  • Health literacy [ Time Frame: Measured at baseline. ]
    Parental health literacy measured using the Short Test Of Functional Health Literacy in Adults. Health literacy will be assessed to explore the impact of health literacy on AAP knowledge and satisfaction, and asthma outcomes, among parents with a child in the PAAP or WAAP group.
  • Reading comprehension [ Time Frame: Measured at baseline. ]
    Reading comprehension among young people will be measured as a proxy for health literacy due to a lack of appropriate health literacy measures for 8-17 year olds. Reading comprehension is being assessed to investigate it's role in determining outcomes among participants in the PAAP versus WAAP groups.
  • Asthma Numeracy [ Time Frame: Measured at baseline. ]
    Parental asthma numeracy will be assessed among parents using the Asthma Numeracy Questionnaire to investigate the role of asthma numeracy at baseline in determining knowledge, satisfaction and child asthma outcomes.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Investigation of the Role of Pictorial Asthma Action Plans to Promote Self-management in Rural Youth With Asthma
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Pictorial Asthma Action Plan
  • Active Comparator: 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.
    Intervention: Behavioral: Written Asthma Action Plan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2019)
45
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2017)
60
Actual Study Completion Date  ICMJE November 12, 2018
Actual Primary Completion Date November 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03187119
Other Study ID Numbers  ICMJE 1612396282A001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christina Duncan, West Virginia University
Study Sponsor  ICMJE West Virginia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christina Duncan, PhD West Virginia University
PRS Account West Virginia University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP