Clinical trial NCT04633018: A Patient-Centered Asthma Management Communication Intervention for Rural Latino Children
Official title: A Patient-Centered Asthma Management Communication Intervention for Rural Latino
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Keywords: mHealth
Latino
asthma
limited English proficiency
pediatrics
school nursing
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mobile app usability and acceptability
timeFrame: 1 week
measure: Preliminary protocol testing of mobile app-facilitated triadic communication
timeFrame: 3 months
measure: Investigate the feasibility of the patient-centered asthma intervention
timeFrame: 6 months
Secondary outcomes:
measure: Medication adherence and lung function tests
timeFrame: 6 months
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Lancaster County School District
state: South Carolina
Study officials:
affiliation: University of South Carolina College of Nursing
name: Robin M Dawson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dawson RM, Heiney SP, Messias DH, Ownby D. A Patient-Centered Asthma Management Communication Intervention for Rural Latino Children: Protocol for a Waiting-List Randomized Controlled Trial. JMIR Res Protoc. 2020 Dec 1;9(12):e18977. doi: 10.2196/18977.