Brief Summary
This study will evaluate the role of using electronic sensors for asthma inhaler devices in monitoring medication adherence and asthma control
Brief Title
Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients
Detailed Description
This study will assess the feasibility of using electronic sensors for asthma inhalers in a population of urban minority adults and children with moderate-severe asthma in the Bronx.
Investigators will also assess differences in asthma outcomes (specifically asthma control as a primary outcome measure) and treatment adherence in a group of participants with moderate-severe asthma who use inhalers with electronic sensors and real-time remote outreach worker monitoring/feedback compared to a group of participants who use inhalers with electronic sensors but without real-time monitoring/feedback.
Investigators will also assess differences in asthma outcomes (specifically asthma control as a primary outcome measure) and treatment adherence in a group of participants with moderate-severe asthma who use inhalers with electronic sensors and real-time remote outreach worker monitoring/feedback compared to a group of participants who use inhalers with electronic sensors but without real-time monitoring/feedback.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Asthma
Eligibility Criteria
Inclusion Criteria:
* Adults (\>18 years) and children (5-11 years old) with a clinical history (i.e. physician-diagnosed) of asthma
* Moderate to severe asthmatics with ≥1 asthma-related ED visits or hospitalizations in the past year
* Use of daily controller inhaler medications
* Adult non-smokers, or lifetime use \<5 pack years with no smoking in last 1 yr
* Smartphone required
* English or Spanish speaking
Exclusion Criteria:
* No smartphone
* Use of oral corticosteroids in prior 4 weeks
* Pregnancy
* Psychiatric conditions
* Adults (\>18 years) and children (5-11 years old) with a clinical history (i.e. physician-diagnosed) of asthma
* Moderate to severe asthmatics with ≥1 asthma-related ED visits or hospitalizations in the past year
* Use of daily controller inhaler medications
* Adult non-smokers, or lifetime use \<5 pack years with no smoking in last 1 yr
* Smartphone required
* English or Spanish speaking
Exclusion Criteria:
* No smartphone
* Use of oral corticosteroids in prior 4 weeks
* Pregnancy
* Psychiatric conditions
Inclusion Criteria
Inclusion Criteria:
* Adults (\>18 years) and children (5-11 years old) with a clinical history (i.e. physician-diagnosed) of asthma
* Moderate to severe asthmatics with ≥1 asthma-related ED visits or hospitalizations in the past year
* Use of daily controller inhaler medications
* Adult non-smokers, or lifetime use \<5 pack years with no smoking in last 1 yr
* Smartphone required
* English or Spanish speaking
* Adults (\>18 years) and children (5-11 years old) with a clinical history (i.e. physician-diagnosed) of asthma
* Moderate to severe asthmatics with ≥1 asthma-related ED visits or hospitalizations in the past year
* Use of daily controller inhaler medications
* Adult non-smokers, or lifetime use \<5 pack years with no smoking in last 1 yr
* Smartphone required
* English or Spanish speaking
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
5 Years
NCT Id
NCT02913092
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2016-7001
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma
Primary Outcomes
Outcome Description
validated asthma control measure
Outcome Measure
Asthma Control Test
Outcome Time Frame
change from baseline to 6 months
Secondary Ids
Secondary Id
Community Service Award
Secondary Outcomes
Outcome Description
measured by electronic sensor
Outcome Time Frame
change from baseline to 6 months
Outcome Measure
Medication adherence
Outcome Description
ED visits and hospitalizations will be assessed via electronic health records
Outcome Time Frame
change from baseline to 6 months
Outcome Measure
Health care utilization
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
5
Investigators
Investigator Type
Principal Investigator
Investigator Name
Marina Reznik
Investigator Email
MREZNIK@montefiore.org
Investigator Phone
718-405-5260