- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02615743
Asthma Controller Adherence After Hospitalization
Automated Adherence Feedback for High Risk Children With Asthma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Poor adherence to inhaled controller medications for asthma is a well-documented and poorly understood problem with a disproportionate prevalence and impact on urban minority children. Recent randomized trials from other countries using electronic monitoring of inhaled steroids with automated adherence feedback demonstrated dramatic improvements in adherence behavior. Whether similar intervention effects can be expected in high-risk children in the US is unknown.
To accomplish the above objectives, investigators propose to enroll 40 children and their parents (20 parent/child dyads in each arm) in a two-month pilot randomized controlled trial of an automated adherence feedback intervention. Children will be from West Philadelphia, ages 4-11, and must be hospitalized for asthma at The Children's Hospital of Philadelphia (CHOP).
The study intervention will include daily automated medication reminders via text messaging for those subjects randomized to the intervention group. Inhaled controller medication adherence will be measured in both groups using electronic monitors affixed to the top of the canister of the inhaled steroid medication and adherence trajectories will be determined using group-based trajectory modeling. Factors associated with adherence trajectories will be assessed using a survey completed upon enrollment, completion of the treatment phase (1 month) and upon completion of follow up (2 months). Feasibility outcomes will include use, acceptance, and preferences. Limited efficacy outcomes will include change in parent-reported asthma control and difference in average percent adherence between intervention and control conditions.
Findings from this study will provide preliminary data for a larger study evaluating the mechanisms of differential adherence trajectories and the effect of an adherence feedback intervention for different mechanisms of non-adherence.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Has unlimited text messaging plan
- Prescribed one of the following metered dose inhalers for daily use: Flovent (fluticasone), QVAR (budesonide), Seretide (fluticasone-salmeterol), Advair multi-dose inhaler (MDI) (fluticasone-salmeterol) or Dulera (mometasone-formoterol)
- Patient receives primary care at one of the three urban CHOP primary care practices (Karabots, South Philadelphia, and Cobbs Creek)
Exclusion Criteria:
- Subjects prescribed a controller medication to which the electronic device cannot affix (i.e. montelukast, Advair Diskus, Symbicort, Seretide Acuhaler/Diskus) as their primary controller medication
- Subjects with developmental delays or disabilities
- Families with active Department of Human Services (DHS) involvement
- Non-English speaking families
- Parents/guardians or subjects who the inpatient medical team recommends against approaching for enrollment in a research study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
Caregivers of intervention arm participants will receive daily text message reminders about asthma controller medication use, as well as an electronic monitoring device to track the participant's medication usage for 60 days following hospital discharge.
At the end of 30 days, participants will be able to opt out of daily text messages if they choose.
All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.
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Subjects in the intervention arm will receive once daily text messages at the time of their choice or at a default time of 7am.
The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.
An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician.
Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters.
The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem.
Data is then sent via the cellular network to the secure Propeller server.
The data will then be downloaded monthly.
Other Names:
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Other: Control Group
Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge.
At 30 days, caregivers of participants will be able to opt in to receive daily text message reminders about asthma medication use.
Caregivers of all participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.
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An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician.
Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters.
The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem.
Data is then sent via the cellular network to the secure Propeller server.
The data will then be downloaded monthly.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Number and Percentage of Patients That Use Monitoring Device Over 30 Days (Feasibility)
Time Frame: 30 days
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The number and percentage of patients that continue to use the monitoring device throughout the month will be compared between the intervention and control groups.
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30 days
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Acceptability
Time Frame: 30 days (intervention group) 60 days (control group)
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The rating of the monitoring device will be compared between groups based on responses to a questionnaire asking about acceptability and preferences to determine if there is a difference in the "favorability" We determined this by the number of participants who found text message reminders helpful to avoid missing doses.
After 30 days caregivers of control group participants were given the option to receive daily text messages; they were asked about acceptability 30 days later.
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30 days (intervention group) 60 days (control group)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence
Time Frame: 30 days
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Percent adherence will be calculated as observed medication actuations from electronic adherence monitors over expected use (the latter is = prescribed daily regimen number of observation days)
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30 days
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Change in Child Asthma Control Tool Score (cACT) From Baseline to End of Intervention Period.
Time Frame: 30 days
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The difference in the change of cACT score from first study visit to the third study visit will be compared between the two study groups.
Asthma Control Test (ACT) provides a numerical score to determine if asthma symptoms are well controlled.
The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control.
An ACT score >19 indicates well controlled asthma.
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30 days
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Chen C Kenyon, MD, MS, Children's Hospital of Philadelphia
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-012092
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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