NCT04633018

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

4.9 years

First QC Date

November 16, 2020

Last Update Submit

November 29, 2023

Conditions

Asthma

Keywords

mHealthLatinoasthmalimited English proficiencypediatricsschool nursing

Outcome Measures

Primary Outcomes (3)

  • Mobile app usability and acceptability

    Participants with Spanish as first language use the translated app for ease of use and identification of interface problems

    1 week

  • 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.

    3 months

  • 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.

    6 months

Secondary Outcomes (1)

  • Medication adherence and lung function tests

    6 months

Study Arms (2)

Patient-centered asthma intervention feasibility

EXPERIMENTAL

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

Device: AsthmaMD mobile application

Wait list control

EXPERIMENTAL

Control group with usual care (not using app).

Other: Usual care

Interventions

AsthmaMD mobile applicationDEVICE

asthma management app with Spanish-language user interface

Patient-centered asthma intervention feasibility
Usual careOTHER

Asthma management without the app

Wait list control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lancaster County School District

Lancaster, South Carolina, 29720, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33258784DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Robin M Dawson, PhD

    University of South Carolina College of Nursing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin Dawson

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 17, 2020

Study Start

August 1, 2019

Primary Completion

June 30, 2024

Study Completion

July 30, 2024

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)