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A Patient-Centered Asthma Management Communication Intervention for Rural Latino Children

A Patient-Centered Asthma Management Communication Intervention for Rural Latino

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04633018
Enrollment
30
Registered
2020-11-17
Start date
2019-08-01
Completion date
2024-07-30
Last updated
2023-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

mHealth, Latino, asthma, limited English proficiency, pediatrics, school nursing

Brief summary

The purpose of this research is to develop and evaluate an mHealth communication intervention designed to improve asthma medication adherence amongst rural Latino children in South Carolina.

Detailed description

The overall prevalence of asthma is highest in the US south, which has one of the fastest growing Latino populations in the country. In South Carolina, asthma is the leading cause of children's hospitalization and emergency department (ED) visits, with significant direct and indirect costs. Although rates of childhood asthma are lower in Latinos (with the exception of children of Puerto Rican origin) than in whites, Latinos are more likely to have a higher incidence of uncontrolled asthma symptoms, ED visits, repeat hospitalizations, and poorer health in general. Current interventions addressing asthma control include outpatient clinic based and home visitation programs. Rural Latino families have difficulty participating with these types of programs due to work, family, and transportation constraints. The adaptability of mobile apps holds the potential to target the unique challenges to management experienced by rural Latino children with asthma experience. The goal of this study is to develop and evaluate a patient-centered collaborative intervention between rural Latino children with asthma and their families, school-based nursing, and primary care providers, facilitated by the use of a smart phone based bilingual mobile app. The specific aims are to: 1. Produce and validate a Spanish translation of an existing asthma management app and evaluate its usability with Latino parents of children with asthma; and 2. Develop and evaluate a triadic, patient-centered asthma intervention preliminary protocol, facilitated by the bilingual mobile app validated in aim 1.

Interventions

DEVICEAsthmaMD mobile application

asthma management app with Spanish-language user interface

OTHERUsual care

Asthma management without the app

Sponsors

University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

1\) children self/family-identified as Hispanic/Latino or African American, 2) school-aged (5-18 years) and attends school within the Lancaster County School District, 3) has received a diagnosis of asthma from a health care provider and is taking a controller medication, and 4) parents/primary caregiver (e.g., grandparents, extended family) language of preference is Spanish or English.

Design outcomes

Primary

MeasureTime frameDescription
Mobile app usability and acceptability1 weekParticipants with Spanish as first language use the translated app for ease of use and identification of interface problems
Preliminary protocol testing of mobile app-facilitated triadic communication3 monthsDevelop and evaluate a triadic, patient-centered asthma intervention preliminary protocol, facilitated by the Spanish language mobile app. Post-intervention data regarding the experiences of the participants in this collaborative intervention will be obtained through a post-intervention focus group facilitated by the PI with the PCPs and school nurses, and five interviews conducted by a bilingual research assistant with the Latino families.
Investigate the feasibility of the patient-centered asthma intervention6 monthsInvestigate the feasibility of the patient-centered asthma intervention from aim 2 using a wait list randomized control trial (RCT) to investigate the effects of the intervention on school days missed and medication adherence. Anticipated quantitative data includes the information entered into the app, encrypted, and transmitted to the school nurse by the parent/caregiver. These data will include selected NIH/AHRQ standardized asthma outcomes,47 including the primary outcome measures of medication adherence information (asthma medication ratio48 - predictive of childhood asthma ED visits and hospitalizations) and school days missed.

Secondary

MeasureTime frameDescription
Medication adherence and lung function tests6 monthsSecondary outcome measures include frequency of rescue inhaler use, as well as asthma exacerbations, outpatient clinic visits, and emergency department visits. Lung capacity will be obtained pre- and post-intervention/bronchodilation using spirometry49 to obtain relevant lung function variables such as FEV1 and FEV1/FVC. Measures from the control group will include medication counts, number of asthma exacerbations, ED/outpatient clinic visits, and spirometry measures on enrollment, during the intervention phase, and again at the end of the intervention.

Countries

United States

Contacts

Primary ContactRobin Dawson
robin.dawson@sc.edu(803) 576-6021

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026