AsthmaNCT04633018
A Patient-Centered Asthma Management Communication Intervention for Rural Latino Children
A study testing AsthmaMD mobile application in people with Asthma, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- AsthmaMD mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Lancaster County School District
Lancaster, South Carolina, 29720
Leigh Lever, RN, 803-416-8884, Leigh.Lever@lcsdmail.net
About this study
Official title: A Patient-Centered Asthma Management Communication Intervention for Rural Latino
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- AsthmaMD mobile application, Usual care
- Keywords
- mHealth, Latino, asthma, limited English proficiency, pediatrics, school nursing
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsthmaMD mobile applicationDevice
asthma management app with Spanish-language user interface
Usual careOther
Asthma management without the app
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AsthmaMD mobile application |
| Wait list control | Experimental | Control group with usual care (not using app). Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobile app usability and acceptability
Participants with Spanish as first language use the translated app for ease of use and identification of interface problems
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Aug 2019
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Dawson, University of South Carolina
- Investigators
- Robin M Dawson, PhD, Principal investigator, University of South Carolina College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633018
- Sponsor's protocol ID
- 1K23HL133596-01A1
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33258784
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-Centered Asthma Management Communication Intervention for Rural Latino
- ClinicalTrials.gov ID
- NCT04633018
- Acronym / sponsor ID
- 1K23HL133596-01A1
- Conditions
- Asthma
- Keywords
- mHealth, Latino, asthma, limited English proficiency, pediatrics, school nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-centered asthma intervention feasibility | Experimental | Device: AsthmaMD mobile applicationInvestigate the effect of the patient-centered asthma intervention using the AsthmaMD app on school days missed and medication adherence. |
| Wait list control | Experimental | Other: Usual careControl group with usual care (not using app). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AsthmaMD mobile applicationasthma management app with Spanish-language user interface | Device | Patient-centered asthma intervention feasibility |
| Usual careAsthma management without the app | Other | Wait list control |
Primary outcome
Mobile app usability and acceptability
Time frame: 1 week
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
Time frame: 3 months
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
Time frame: 6 months
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.
1 secondary outcome
Medication adherence and lung function tests
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Derived from this study: PubMed 33258784Dawson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin M Dawson, PhD principal investigator
University of South Carolina College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AsthmaMD mobile application in people with Asthma, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robin Dawson ((803) 576-6021, robin.dawson@sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobile app usability and acceptability (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04633018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.