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An Asthma Mobile Intervention to Promote Patient-Reported Outcomes in Primary Care

Adapting, Scaling, and Spreading an Algorithmic Asthma Mobile Intervention to Promote Patient-Reported Outcomes Within Primary Care Settings

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03847142
Enrollment
110
Registered
2019-02-20
Start date
2020-03-01
Completion date
2023-05-01
Last updated
2023-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

informatics, asthma

Brief summary

Through this study, the investigators will adapt the ASTHMAXcel mobile app and evaluate the adapted intervention through a randomized controlled trial.

Detailed description

Through this study, the investigators will use patient and provider feedback to adapt the ASTHMAXcel mobile intervention, and will conduct a randomized controlled trial to test the intervention's impact on clinical and process outcomes.

Interventions

OTHERASTHMAXcel mobile application

ASTHMAXcel is a mobile application (patient-facing) that delivers guideline-based asthma education.

OTHEROutpatient primary care

Usual care delivered through the outpatient primary care setting

Sponsors

Montefiore Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Through the randomized controlled trial component, there will be 2 arms, which include the ASTHMAXcel intervention and usual care delivered through the outpatient primary care setting.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

English-speaking individuals \>18 years with: 1. persistent asthma(diagnosis made by a healthcare provider) on a daily controller medication 2. able to give informed consent 3. Smartphone (iOS or Android) access

Exclusion criteria

1. use of oral corticosteroids in the 2 weeks prior to the baseline visit 2. pregnancy 3. severe psychiatric or cognitive problems that would prohibit an individual from completing the protocol 4. patients that previously received ASTHMAXcel

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline asthma quality of life to 2, 6, and 12 monthsBaseline, 2 months, 6 months, 12 monthsPatients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)

Secondary

MeasureTime frameDescription
Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment QuestionnaireBaseline, 2 months, 6 months, 12 monthsProvider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire
Change from baseline asthma knowledge to 2 months, 6 months, and 12 monthsBaseline, 2 months, 6 months, 12 monthsAsthma knowledge as measured by the validated KASE asthma questionnaire
Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaireBaseline, 2 months, 6 months, 12 monthsPatient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire
Patient satisfaction measured by the Client Satisfaction Questionnaire-8Baseline, 2 months, 6 months, 12 monthsPatient satisfaction measured by the Client Satisfaction Questionnaire-8
Depression as measured by the Patient Health Questionnaire-9Baseline, 2 months, 6 months, 12 monthsDepression as measured by the Patient Health Questionnaire-9
Number of asthma emergency department visitsBaseline, 2 months, 6 months, 12 monthsNumber of asthma emergency department visits
Number of asthma hospitalizationsBaseline, 2 months, 6 months, 12 monthsNumber of asthma hospitalizations
Change from baseline asthma control to 2, 6, and 12 monthsBaseline, 2 months, 6 months, 12 monthsAsthma symptom burden as measured by the Asthma Control Test

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026