Asthma Implementation Research Trial
Condition: Asthma; Asthma in Children
MeSH terms: Asthma
Study type: Interventional

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.
    


Intervention name(s): Self-management Intervention Package
Intervention type(s): Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Implementation Science; Global Health; Peru