Clinical trial NCT02615743: Asthma Controller Adherence After Hospitalization
Official title: Automated Adherence Feedback for High Risk Children With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2015-11-26
Enrollment: 41
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of Number and Percentage of Patients That Use Monitoring Device Over 30 Days (Feasibility)
timeFrame: 30 days
measure: Acceptability
timeFrame: 30 days (intervention group) 60 days (control group)
Secondary outcomes:
measure: Adherence
timeFrame: 30 days
measure: Change in Child Asthma Control Tool Score (cACT) From Baseline to End of Intervention Period.
timeFrame: 30 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Chen C Kenyon, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adams SA, Leach MC, Feudtner C, Miller VA, Kenyon CC. Automated Adherence Reminders for High Risk Children With Asthma: A Research Protocol. JMIR Res Protoc. 2017 Mar 27;6(3):e48. doi: 10.2196/resprot.6674.