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Completed

NCT Number: NCT02615743

Asthma Controller Adherence After Hospitalization

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daily Text message reminder

Behavioral

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.

Inhaled steroid canister monitor

Device

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: Propeller Health Bluetooth Low Energy (BLE) Sensor

Primary outcomes

  1. Comparison of Number and Percentage of Patients That Use Monitoring Device Over 30 Days (Feasibility)

    Time frame: 30 days

    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.

  2. Acceptability

    Time frame: 30 days (intervention group) 60 days (control group)

    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.

Secondary outcomes

  1. Adherence

    Time frame: 30 days

    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)

  2. Change in Child Asthma Control Tool Score (cACT) From Baseline to End of Intervention Period.

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • University of Pennsylvania

Registry information

Official study title

Automated Adherence Feedback for High Risk Children With Asthma

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 26, 2015
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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