Clinical trial NCT03986177: Asthma Implementation Research Trial
Official title: Implementation of a Community Intervention to Improve Asthma Self-Management Practices in Peru
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Asthma in Children
Keywords: Implementation Science
Global Health
Peru
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Asociacion Benefica Prisma
name: Hospital Nacional Cayetano Heredia
name: American Thoracic Society
First posted: 2019-06-14
Enrollment: 110
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Change in Asthma Control as assessed by Childhood Asthma Control Test (cACT) Score
timeFrame: Baseline, then monthly up to 6 months
measure: Change in Asthma Control as assessed by Asthma Control Test (ACT) Score
timeFrame: Baseline, then monthly up to 6 months
measure: Number of participants with at least one asthma-related ED or urgent care visit during the six-month follow-up period
timeFrame: 6 months
Secondary outcomes:
measure: Change in Adherence to Refills and Medications Scale-7 (ARMS-7) score
timeFrame: Baseline, then monthly up to 6 months
measure: Medication adherence as assessed by Dose counter-measured medication use
timeFrame: 6 months
measure: Quality of life as assessed by Pediatric Asthma Quality of Life Questionnaire (PAQLQ)-Mini
timeFrame: 6 months
measure: Quality of life in caregivers of children and adolescents with asthma as assessed by Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
timeFrame: 6 months
measure: Depression as assessed by Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 6 months
measure: Number of participants with asthma-related hospitalizations
timeFrame: 6 months
measure: Number of participants with all-cause emergency department (ED) or urgent care visits
timeFrame: 6 months
measure: Number of participants who attend two or more outpatient appointments with healthcare provider for asthma.
timeFrame: 6 months
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Hospital Nacional Cayetano Heredia
Study officials:
affiliation: Johns Hopkins University
name: Suzanne Pollard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Romani ED, Siddharthan T, Lovaton N, Alvitez-Luna CC, Flores-Flores O, Pollard SL. Implementation of an intervention to improve the adoption of asthma self-management practices in Peru: Asthma Implementation Research (AIRE) randomized trial study protocol. Trials. 2020 May 4;21(1):377. doi: 10.1186/s13063-020-4207-5.