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Asthma Implementation Research Trial (AIRE)

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ClinicalTrials.gov Identifier: NCT03986177
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborators:
Asociación Benéfica Prisma
Hospital Nacional Cayetano Heredia
American Thoracic Society
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Asthma is the most common chronic disease among children worldwide, with 80% of asthma related deaths occurring in low- and middle-income countries (LMICs), such as Peru. While evidence-based guidelines exist for asthma treatment and management, adherence to guideline-based practices is low in high-income country (HIC) and LMIC settings alike. There a clear need for effective, locally-tailored solutions to address the asthma treatment gap in low-income communities in LMICs, such as Peru. This study aims to develop and test a locally-adapted intervention package to improve adoption of self-management practices and utilization of preventive health services for asthma among children in Lima. There is a paucity of research regarding the development and testing of interventions to improve asthma self-management in LMIC settings, which experience unique or exacerbated barriers to receiving evidence-based care. To the investigators' knowledge, no studies have systematically developed and evaluated an asthma management program in Peru. Therefore, the long-term goal of this study is to disseminate locally appropriate asthma management strategies to reduce asthma-related emergency department visits and improve service utilization in LMIC settings. For the current study, the investigators will carry out a randomized controlled trial to test the effectiveness of the intervention package in a group of 110 children with asthma who will be randomized to the intervention (55 children) or no intervention (55 children) arm. Participants in the intervention group will receive case management from a designated nurse manager, who will provide ongoing educational, social, and self-management support during monthly follow-up home visits and text-message based communication. Participants will be followed up every month for data collection over a six-month period. Throughout the follow-up period, the investigators will collect data on asthma control, healthcare utilization, medication adherence, quality of life of children with asthma and the children's caregivers, caregiver mental health, fidelity to the intervention, and acceptability and feasibility. Ultimately, this study will inform the scientific community about effective strategies and treatment programs for asthma in low-income settings.

Condition or disease Intervention/treatment Phase
Asthma Asthma in Children Behavioral: Self-management Intervention Package Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Implementation of a Community Intervention to Improve Asthma Self-Management Practices in Peru
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Intervention
The intervention arm will receive a multi-faceted self-management intervention package.
Behavioral: Self-management Intervention Package

Children will receive basic asthma education, based on the National Heart, Lung, and Blood Institute "A Breath of Life" asthma education program. Children/caregivers in the intervention arm will also be assigned a designated nurse case manager who will provide home visits and be available via text message and phone-based support throughout follow-up. Intervention components:

  • Interactive education and support on use of an asthma action plan
  • Locally adapted patient-provider communication tool
  • Child-oriented educational materials in comic book format
  • Modeling and hands-on practice of inhaler technique (written instructions, in person, video)
  • Education regarding environmental trigger abatement
  • Patient navigation, home visits, and goal setting support from nurse manager

No Intervention: Enhanced care
The control arm will receive usual care plus basic asthma education from a trained nurse educator.



Primary Outcome Measures :
  1. Change in Asthma Control as assessed by Childhood Asthma Control Test (cACT) Score [ Time Frame: Baseline, then monthly up to 6 months ]
    cACT (5-11 years of age) will be administered at baseline and monthly during the follow-up period. The cACT is scored by summing the scores for all items. Overall scores ranges from 0 to 27. Lower scores indicate poorer asthma control and higher scores indicate better asthma control. Scores 19 and below suggest impaired asthma control.

  2. Change in Asthma Control as assessed by Asthma Control Test (ACT) Score [ Time Frame: Baseline, then monthly up to 6 months ]
    ACT (12-17 years of age) will be administered at baseline and monthly during the follow-up period. The ACT is scored by summing the scores for all items. Overall score ranges from 5 to 25. Lower scores indicate poorer asthma control and higher scores indicate better asthma control. Scores 19 and below suggest impaired asthma control.

  3. Number of participants with at least one asthma-related ED or urgent care visit during the six-month follow-up period [ Time Frame: 6 months ]
    Number with asthma-related emergency department (ED) or urgent care visits will be used to assess healthcare utilization.


Secondary Outcome Measures :
  1. Change in Adherence to Refills and Medications Scale-7 (ARMS-7) score [ Time Frame: Baseline, then monthly up to 6 months ]
    ARMS-7 will administered at baseline and monthly during the follow-up period. Score is calculated by summing the scores for all items. Overall score ranges between 7 and 28. Lower scores indicate better adherence.

  2. Medication adherence as assessed by Dose counter-measured medication use [ Time Frame: 6 months ]
    Number of puffs used divided by the number of puffs indicated to be used over monthly follow-up period.

  3. Quality of life as assessed by Pediatric Asthma Quality of Life Questionnaire (PAQLQ)-Mini [ Time Frame: 6 months ]
    Measures disease-specific quality of life in children and adolescents with asthma. The PAQLQ-mini has 13 items, each scored on a 7-point Likert scale with "1" indicating severe impairment and "7" indicating no impairment. Score is calculated by taking the average of scores for each item. Higher scores indicate better quality of life. Range: [1 to 7].

  4. Quality of life in caregivers of children and adolescents with asthma as assessed by Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) [ Time Frame: 6 months ]
    Measures quality of life in caregivers of children and adolescents with asthma. The PACQLQ has 13 items, each scored on a 7-point Likert scale with "1" indicating severe impairment and "7" indicating no impairment. Score is calculated by taking the average of scores for each item. Higher scores indicate better quality of life. Range: [1 to 7].

  5. Depression as assessed by Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 6 months ]
    Measures depressive symptoms. Will be administered to caregivers of children and adolescents with asthma. The PHQ-9 has nine items, each scored on a Likert scale from 0 to 3. Higher scores indicate more evidence of depressive disorder of greater severity of disorder. Scores are calculated by summing the scores for all items. Range: [0 to 27].

  6. Number of participants with asthma-related hospitalizations [ Time Frame: 6 months ]
    Count of participants (children) with at least one asthma-related hospitalization during six-month follow-up period.

  7. Number of participants with all-cause emergency department (ED) or urgent care visits [ Time Frame: 6 months ]
    Count of participants with at least one all-cause ED or urgent care visit during the six-month follow-up period.

  8. Number of participants who attend two or more outpatient appointments with healthcare provider for asthma. [ Time Frame: 6 months ]
    Count of participants who attend two or more outpatient appointments with healthcare provider for asthma over six-month follow-up period.



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently living in Lima, Peru
  • 5-17 years of age
  • Has a physician diagnosis of asthma
  • Has attended the emergency room or urgent care for asthma, or has been hospitalized for asthma at least once in the previous 12 months

Exclusion Criteria:

  • Family plans to move out of the study community within the next 12 months
  • Co-occurring chronic respiratory or cardiovascular disorders other than asthma
  • Active tuberculosis or are currently taking tuberculosis medications
  • Diagnosis of HIV/AIDS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986177


Contacts
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Contact: Suzanne Pollard, PhD (443) 287-4287 spollard@jhu.edu

Locations
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Peru
Hospital Nacional Cayetano Heredia Recruiting
Lima, Peru
Contact: Elisa Romani       aire.johnshopkins@gmail.com   
Sponsors and Collaborators
Johns Hopkins University
Asociación Benéfica Prisma
Hospital Nacional Cayetano Heredia
American Thoracic Society
Investigators
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Principal Investigator: Suzanne Pollard, PhD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03986177     History of Changes
Other Study ID Numbers: IRB00170462
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Implementation Science
Global Health
Peru

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases