Asthma Controller Adherence After Hospitalization
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 4 - 11 |
| Updated: | 4/17/2018 |
| Start Date: | December 2015 |
| End Date: | October 2016 |
Automated Adherence Feedback for High Risk Children With Asthma
This study sets out to assess whether daily text message reminders help to enhance the
consistency of use of controller medications following hospitalization for pediatric asthma
patients ages 4-11 and their families. Text message reminders will be delivered to a
subject's cell phone for those in the intervention group and electronic monitors will placed
on the controller inhalers at the time of hospital discharge to track medication use over
time in both the intervention and the regular care group. Families will complete surveys on
the day of enrollment (in person), day 30 (telephone) and day 60 (telephone) on aspects of
asthma care including asthma knowledge, medication routines, who is responsible for asthma
care, and medication beliefs.
consistency of use of controller medications following hospitalization for pediatric asthma
patients ages 4-11 and their families. Text message reminders will be delivered to a
subject's cell phone for those in the intervention group and electronic monitors will placed
on the controller inhalers at the time of hospital discharge to track medication use over
time in both the intervention and the regular care group. Families will complete surveys on
the day of enrollment (in person), day 30 (telephone) and day 60 (telephone) on aspects of
asthma care including asthma knowledge, medication routines, who is responsible for asthma
care, and medication beliefs.
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.
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.
Inclusion Criteria:
1. Has unlimited text messaging plan
2. 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)
3. Patient receives primary care at one of the three urban CHOP primary care practices
(Karabots, South Philadelphia, and Cobbs Creek)
Exclusion Criteria:
1. 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
2. Subjects with developmental delays or disabilities
3. Families with active Department of Human Services (DHS) involvement
4. Non-English speaking families
5. Parents/guardians or subjects who the inpatient medical team recommends against
approaching for enrollment in a research study
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Phone: 267-426-6339
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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