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

NCT ID: NCT04633018

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2024-07-30

Brief Summary

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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

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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.

Conditions

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Asthma

Keywords

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mHealth Latino asthma limited English proficiency pediatrics school nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patient-centered asthma intervention feasibility

Investigate the effect of the patient-centered asthma intervention using the AsthmaMD app on school days missed and medication adherence.

Group Type EXPERIMENTAL

AsthmaMD mobile application

Intervention Type DEVICE

asthma management app with Spanish-language user interface

Wait list control

Control group with usual care (not using app).

Group Type EXPERIMENTAL

Usual care

Intervention Type OTHER

Asthma management without the app

Interventions

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AsthmaMD mobile application

asthma management app with Spanish-language user interface

Intervention Type DEVICE

Usual care

Asthma management without the app

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Robin Dawson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robin M Dawson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina College of Nursing

Locations

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Lancaster County School District

Lancaster, South Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Robin Dawson

Role: CONTACT

Phone: (803) 576-6021

Email: [email protected]

Facility Contacts

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Leigh Lever, RN

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33258784 (View on PubMed)

Other Identifiers

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1K23HL133596-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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