Clinical trial NCT03847142: An Asthma Mobile Intervention to Promote Patient-Reported Outcomes in Primary Care
Official title: Adapting, Scaling, and Spreading an Algorithmic Asthma Mobile Intervention to Promote Patient-Reported Outcomes Within Primary Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: informatics
asthma
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline asthma quality of life to 2, 6, and 12 months
timeFrame: Baseline, 2 months, 6 months, 12 months
Secondary outcomes:
measure: Patient satisfaction measured by the Client Satisfaction Questionnaire-8
timeFrame: Baseline, 2 months, 6 months, 12 months
measure: Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire
timeFrame: Baseline, 2 months, 6 months, 12 months
measure: Change from baseline asthma knowledge to 2 months, 6 months, and 12 months
timeFrame: Baseline, 2 months, 6 months, 12 months
measure: Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire
timeFrame: Baseline, 2 months, 6 months, 12 months
measure: Change from baseline asthma control to 2, 6, and 12 months
timeFrame: Baseline, 2 months, 6 months, 12 months
measure: Depression as measured by the Patient Health Questionnaire-9
timeFrame: Baseline, 2 months, 6 months, 12 months
measure: Number of asthma emergency department visits
timeFrame: Baseline, 2 months, 6 months, 12 months
measure: Number of asthma hospitalizations
timeFrame: Baseline, 2 months, 6 months, 12 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Sunit Jariwala
role: PRINCIPAL_INVESTIGATOR
References: