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Completed

NCT Number: NCT03986177

Asthma Implementation Research Trial

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.

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Key information

Conditions

Asthma Asthma in Children Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Nacional Cayetano Heredia

Lima, Peru

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-management Intervention Package

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • American Thoracic Society
  • Asociacion Benefica Prisma
  • Hospital Nacional Cayetano Heredia

Registry information

Official study title

Implementation of a Community Intervention to Improve Asthma Self-Management Practices in Peru

Acronym: AIRE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 14, 2019
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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