Asthma Implementation Research Trial (AIRE)

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Johns Hopkins University

Status

Completed

Conditions

Asthma
Asthma in Children

Treatments

Behavioral: Self-management Intervention Package

Study type

Interventional

Funder types

Other

Identifiers

NCT03986177
IRB00170462

Details and patient eligibility

About

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.

Enrollment

110 patients

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

110 participants in 2 patient groups

Intervention
Experimental group
Description:
The intervention arm will receive a multi-faceted self-management intervention package.
Treatment:
Behavioral: Self-management Intervention Package
Enhanced care
No Intervention group
Description:
The control arm will receive usual care plus basic asthma education from a trained nurse educator.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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