Brief Summary
Through this study, the investigators will adapt the ASTHMAXcel mobile app and evaluate the adapted intervention through a randomized controlled trial.
Brief Title
An Asthma Mobile Intervention to Promote Patient-Reported Outcomes in Primary Care
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Asthma
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
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
Inclusion 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
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
Gender
All
Gender Based
false
Keywords
informatics
asthma
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03847142
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2018-9027
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Adapting, Scaling, and Spreading an Algorithmic Asthma Mobile Intervention to Promote Patient-Reported Outcomes Within Primary Care Settings
Primary Outcomes
Outcome Description
Patients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)
Outcome Measure
Change from baseline asthma quality of life to 2, 6, and 12 months
Outcome Time Frame
Baseline, 2 months, 6 months, 12 months
Secondary Ids
Secondary Id
R18HS025645
Secondary Outcomes
Outcome Description
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Outcome Time Frame
Baseline, 2 months, 6 months, 12 months
Outcome Measure
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Outcome Description
Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire
Outcome Time Frame
Baseline, 2 months, 6 months, 12 months
Outcome Measure
Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire
Outcome Description
Asthma knowledge as measured by the validated KASE asthma questionnaire
Outcome Time Frame
Baseline, 2 months, 6 months, 12 months
Outcome Measure
Change from baseline asthma knowledge to 2 months, 6 months, and 12 months
Outcome Description
Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire
Outcome Time Frame
Baseline, 2 months, 6 months, 12 months
Outcome Measure
Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire
Outcome Description
Asthma symptom burden as measured by the Asthma Control Test
Outcome Time Frame
Baseline, 2 months, 6 months, 12 months
Outcome Measure
Change from baseline asthma control to 2, 6, and 12 months
Outcome Description
Depression as measured by the Patient Health Questionnaire-9
Outcome Time Frame
Baseline, 2 months, 6 months, 12 months
Outcome Measure
Depression as measured by the Patient Health Questionnaire-9
Outcome Description
Number of asthma emergency department visits
Outcome Time Frame
Baseline, 2 months, 6 months, 12 months
Outcome Measure
Number of asthma emergency department visits
Outcome Description
Number of asthma hospitalizations
Outcome Time Frame
Baseline, 2 months, 6 months, 12 months
Outcome Measure
Number of asthma hospitalizations
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sunit Jariwala
Investigator Email
sjariwal@montefiore.org