Asthma Implementation Research Trial

NCT03986177 | Completed

• 1 other identifier: IRB00170462
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Asthma in Children

Keywords

Implementation Science; Global Health; Peru

Outcome Measures

Primary Outcomes (3)

• Change in Asthma Control as assessed by Childhood Asthma Control Test (cACT) Score

  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.

  Baseline, then monthly up to 6 months

• Change in Asthma Control as assessed by Asthma Control Test (ACT) Score

  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.

  Baseline, then monthly up to 6 months

• Number of participants with at least one asthma-related ED or urgent care visit during the six-month follow-up period

  Number with asthma-related emergency department (ED) or urgent care visits will be used to assess healthcare utilization.

  6 months

Secondary Outcomes (8)

• Change in Adherence to Refills and Medications Scale-7 (ARMS-7) score

  Baseline, then monthly up to 6 months

• Medication adherence as assessed by Dose counter-measured medication use

  6 months

• Quality of life as assessed by Pediatric Asthma Quality of Life Questionnaire (PAQLQ)-Mini

  6 months

• Quality of life in caregivers of children and adolescents with asthma as assessed by Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)

  6 months

• Depression as assessed by Patient Health Questionnaire-9 (PHQ-9)

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention arm will receive a multi-faceted self-management intervention package.

Behavioral: Self-management Intervention Package

Enhanced care

NO INTERVENTION

The control arm will receive usual care plus basic asthma education from a trained nurse educator.

Interventions

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

Intervention

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Currently living in Lima, Peru
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Asociacion Benefica Prisma: collaborator
• Hospital Nacional Cayetano Heredia: collaborator
• American Thoracic Society: collaborator

Study Sites (1)

Hospital Nacional Cayetano Heredia

Lima, Peru

Location

Related Publications (2)

• Zevallos-Morales A, Romani-Huacani E, Psoter KJ, Flores-Flores O, Reif D, Siddharthan T, Portell M, Anguera MT, Underhill LJ, Pollard SL. Effectiveness and implementation of a multi-faceted intervention to facilitate adoption of asthma self-management practices in Peruvian children and adolescents: a hybrid type 2 individually randomized controlled trial. Front Public Health. 2026 Jan 13;13:1710746. doi: 10.3389/fpubh.2025.1710746. eCollection 2025.

  PMID: 41607915 DERIVED

• 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.

  PMID: 32366314 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Suzanne Pollard, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: June 3, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-05

Locations

PE (1)