Implementation of an intervention to improve the adoption of asthma self-management practices in Peru: Asthma Implementation Research (AIRE) randomized trial study protocol

Elisa D Romani, Trishul Siddharthan, Nair Lovatón, Carol C Alvítez-Luna, Oscar Flores-Flores, Suzanne L Pollard, Elisa D Romani, Trishul Siddharthan, Nair Lovatón, Carol C Alvítez-Luna, Oscar Flores-Flores, Suzanne L Pollard

Abstract

Introduction: Asthma is the most common chronic disease among children worldwide, with 80% of asthma-related deaths occurring in low- and middle-income countries (LMICs). While evidence-based guidelines exist for asthma treatment and management, adoption of guideline-based practices is low in high-income country and LMIC settings alike. While asthma prevalence among children and adolescents in Lima, Peru is in the range of 13%-19.6%, our data suggest that < 5% of children in low-resource communities are currently taking guideline-based therapies. There is an urgent need for effective, locally tailored solutions to address the asthma treatment gap in low-income communities in Peru.

Methods: 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 Norte. The intervention package was designed using a systematic, theory-based framework (Capability, Opportunity, Motivation - Behavior Framework) and is rooted in a multi-phased formative research approach. The main study design is an individually randomized implementation-effectiveness hybrid trial enrolling 110 children aged 5-17 years with asthma and their caregivers. Families allocated to the treatment group receive the supported self-management intervention package, while families allocated to the control group receive the standard of care plus asthma education. We will follow participants monthly for six months and evaluate asthma control (Asthma Control Test), healthcare utilization, and medication adherence (Adherence to Refills and Medications Scale). Disease-specific quality of life for children (Pediatric Asthma Quality of Life Questionnaire) and caregivers (Pediatric Asthma Caregiver's Quality of Life Questionnaire) will be evaluated at baseline, 3 months, and 6 months. We will also evaluate acceptability, feasibility, and fidelity of the intervention using mixed methods approaches.

Discussion: The long-term goal of this study is to disseminate locally appropriate asthma management strategies in LMIC settings. This study will contribute to the body of knowledge surrounding approaches for developing and evaluating intervention strategies for asthma using systematic, theory-based approaches grounded in local context. Such strategies have the potential to inform the development and adaptation of appropriate and scalable solutions for asthma management in LMIC settings.

Trial registration: ClinicalTrials.gov, NCT03986177. Registered on 14 June 2019.

Keywords: Asthma; Asthma action plan; Asthma community home visit; Asthma self-management practices; Implementation Science; Randomized controlled trial.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram of Asthma Implementation Research phases
Fig. 2
Fig. 2
Theoretical framework and targeted barriers of the multi-component intervention package to promote adoption of asthma self-management practices
Fig. 3
Fig. 3
Participant timeline for the individually randomized trial

References

    1. Global Asthma Network . The global asthma report 2018. Auckland: Global Asthma Network; 2018.
    1. Braman SS. The global burden of asthma. Chest. 2006;130:4–12. doi: 10.1378/chest.130.1_suppl.4S.
    1. Lai C, Beasley R, Crane J, Foliaki S, Shah J, Weiland S. Global variation in the prevalence and severity of asthma symptoms: phase three of the International Study of Asthma and Allergies in Childhood (ISAAC) Thorax. 2009;64(6):476–483. doi: 10.1136/thx.2008.106609.
    1. Robinson CL, Baumann LM, Romero K, Combe JM, Gomez A, Gilman RH, et al. Effect of urbanisation on asthma, allergy and airways inflammation in a developing country setting. Thorax. 2011;66:1051–1057. doi: 10.1136/thx.2011.158956.
    1. National Asthma Education and Prevention Program Expert Panel Report 3 (EPR-3): guidelines for the diagnosis and management of asthma summary report 2007. J Allergy Clin Immunol. 2007;120(5 Suppl):S94–138.
    1. Global Initiative for Asthma. Global strategy for asthma management and prevention, 2019. . Accessed 20 Feb 2020.
    1. Peru Ministry of Health . Guías de práctica clínica para la atención de las patologías más frecuentes y cuidados esenciales del niño y la niña: Enfermedades respiratorias. 2006. pp. 39–57.
    1. Pinnock H, Parke HL, Panagioti M, Daines L, Pearce G, Epiphaniou E, Bower P, Sheikh A, Griffiths CJ, Taylor SJC, PRISMA and RECURSIVE groups Systematic meta-review of supported self-management practices for asthma: a healthcare perspective. BMC Med. 2017;15(1):64. doi: 10.1186/s12916-017-0823-7.
    1. Ahmed S, Steed L, Harris K, Taylor SJC, Pinnock H. Interventions to enhance the adoption of asthma self-management behaviour in South Asian and African American populations: a systematic review. NPJ Prim Care Respir Med. 2018;28:5. doi: 10.1038/s41533-017-0070-6.
    1. Peru Ministry of Health. Recursos Humanos en Salud de Perú: Segundo Informe al País 2011. . Accessed 20 Feb 2020.
    1. Michie S, van Stralen MM, West R. The behaviour change wheel: A new method for characterising and designing behaviour change interventions. Implement Sci. 2011;6:42. doi: 10.1186/1748-5908-6-42.
    1. SaludMadrid: Gerencia Asistencial de Atención Primaria. Guía de cuidados: Terapia Inhalada. 2016. . Accessed 20 Feb 2020.
    1. Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009;124(4):719–23.e1. doi: 10.1016/j.jaci.2009.06.053.
    1. Juniper EF, Guyatt GH, Feeny DH, Ferrie PJ, Griffith LE, Townsend M. Measuring quality of life in children with asthma. Qual Life Res. 1996;5(1):35–46. doi: 10.1007/BF00435967.
    1. Juniper EF, Guyatt GH, Feeny DH, Ferrie PJ, Griffith LE, Townsend M. Measuring quality of life in the parents of children with asthma. Qual Life Res. 1996;5:27–34. doi: 10.1007/BF00435966.
    1. Kripalani S, Risser J, Gatti ME, Jacobson TA. Development and evaluation of the Adherence to Refills and Medications Scale (ARMS) among low-literacy patients with chronic disease. Value Health. 2009;12(1):118–123. doi: 10.1111/j.1524-4733.2008.00400.x.
    1. Pollard SL, Lima JJ, Romero K, Tarazona-Meza C, Mougey E, Tomaino K, Malpartida-Guzmán G, Hansel NN, Checkley W. Associations between serum 25(OH) D concentrations and prevalent asthma among children living in communities with differing levels of urbanization: a cross-sectional study. Asthma Res Pract. 2017;3:5. doi: 10.1186/s40733-017-0033-2.

Source: PubMed

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