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

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AsthmaMD mobile application
Usual care
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring mHealth, Latino, asthma, limited English proficiency, pediatrics, school nursing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1) children self/family-identified as Hispanic or Latino, 2) school-aged (5-12 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.

Sites / Locations

  • Lancaster County School DistrictRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient-centered asthma intervention feasibility

Wait list control

Arm Description

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

Control group with usual care (not using app).

Outcomes

Primary Outcome Measures

Mobile app usability and acceptability
Participants 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 communication
Develop 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 intervention
Investigate 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 Outcome Measures

Medication adherence and lung function tests
Secondary 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.

Full Information

First Posted
November 16, 2020
Last Updated
September 27, 2021
Sponsor
University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT04633018
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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: Produce and validate a Spanish translation of an existing asthma management app and evaluate its usability with Latino parents of children with asthma; and Develop and evaluate a triadic, patient-centered asthma intervention preliminary protocol, facilitated by the bilingual mobile app validated in aim 1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
mHealth, Latino, asthma, limited English proficiency, pediatrics, school nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient-centered asthma intervention feasibility
Arm Type
Experimental
Arm Description
Investigate the effect of the patient-centered asthma intervention using the AsthmaMD app on school days missed and medication adherence.
Arm Title
Wait list control
Arm Type
Experimental
Arm Description
Control group with usual care (not using app).
Intervention Type
Device
Intervention Name(s)
AsthmaMD mobile application
Intervention Description
asthma management app with Spanish-language user interface
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Asthma management without the app
Primary Outcome Measure Information:
Title
Mobile app usability and acceptability
Description
Participants with Spanish as first language use the translated app for ease of use and identification of interface problems
Time Frame
1 week
Title
Preliminary protocol testing of mobile app-facilitated triadic communication
Description
Develop 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.
Time Frame
3 months
Title
Investigate the feasibility of the patient-centered asthma intervention
Description
Investigate 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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Medication adherence and lung function tests
Description
Secondary 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.
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1) children self/family-identified as Hispanic or Latino, 2) school-aged (5-12 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Dawson
Phone
(803) 576-6021
Email
robin.dawson@sc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin M Dawson, PhD
Organizational Affiliation
University of South Carolina College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lancaster County School District
City
Lancaster
State/Province
South Carolina
ZIP/Postal Code
29720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leigh Lever, RN
Phone
803-416-8884
Email
Leigh.Lever@lcsdmail.net

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33258784
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.
Results Reference
derived

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

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