Asthma
Conditions
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.
Interventions
BEHAVIORALDaily Text message reminder
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.
DEVICEInhaled steroid canister monitor
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.
Sponsors
University of Pennsylvania
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Number and Percentage of Patients That Use Monitoring Device Over 30 Days (Feasibility) | 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. |
| Acceptability | 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
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 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) |
| Change in Child Asthma Control Tool Score (cACT) From Baseline to End of Intervention Period. | 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. |
Countries
United States
Participant flow
Pre-assignment details
Children were the participants enrolled in the study, parents/caregivers were not.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Caregivers of intervention participants will receive daily text message reminders about asthma controller medication use and an electronic monitoring device to track their medication use for 60 days following hospital discharge. 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.
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. 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. | 21 |
| Control Group Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. 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.
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. | 20 |
| Total | 41 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Continuous | 5.8 years STANDARD_DEVIATION 2.1 | 6.1 years STANDARD_DEVIATION 2.1 | 5.9 years STANDARD_DEVIATION 2.1 |
| Baseline adherence intent , mean (std) | 85 percentage of intended medication STANDARD_DEVIATION 21 | 80 percentage of intended medication STANDARD_DEVIATION 23 | 85 percentage of intended medication STANDARD_DEVIATION 21 |
| Baseline Caregiver Asthma Knowledge Questionnaire | 92 percentage score STANDARD_DEVIATION 8.4 | 93 percentage score STANDARD_DEVIATION 8.7 | 93 percentage score STANDARD_DEVIATION 8.5 |
| Baseline child Asthma Control Test | 17.2 units on a scale STANDARD_DEVIATION 4.7 | 17.8 units on a scale STANDARD_DEVIATION 4.3 | 17.3 units on a scale STANDARD_DEVIATION 4.4 |
| Baseline prior adherence (caregiver-reported), mean (std) | 62 percentage of medication taken STANDARD_DEVIATION 25 | 65 percentage of medication taken STANDARD_DEVIATION 23 | 64 percentage of medication taken STANDARD_DEVIATION 24 |
| Child Health Insurance private | 4 Participants | 1 Participants | 5 Participants |
| Child Health Insurance public | 16 Participants | 20 Participants | 36 Participants |
| Family Income Level <$30,000 | 12 Participants | 15 Participants | 27 Participants |
| Family Income Level >$30,000 | 8 Participants | 6 Participants | 14 Participants |
| Primary Caregiver Education High School or less | 7 primary caregiver of participant | 14 primary caregiver of participant | 21 primary caregiver of participant |
| Primary Caregiver Education Some College and above | 13 primary caregiver of participant | 7 primary caregiver of participant | 20 primary caregiver of participant |
| Prior asthma-related emergency department visits in year before enrollment, mean (std) | 1.0 visits STANDARD_DEVIATION 1.6 | 1.0 visits STANDARD_DEVIATION 1.5 | 1.0 visits STANDARD_DEVIATION 1.5 |
| Prior asthma-related hospitalizations in year before enrollment, mean (std) | 0.5 hospitalizations STANDARD_DEVIATION 0.8 | 0.3 hospitalizations STANDARD_DEVIATION 0.6 | 0.4 hospitalizations STANDARD_DEVIATION 0.7 |
| Race/Ethnicity, Customized Black | 15 Participants | 20 Participants | 35 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 1 Participants | 6 Participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
Primary
Acceptability
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.
Time frame: 30 days (intervention group) 60 days (control group)
Population: There were 6 participants missing from the intervention group due to loss to followup. There were only 5 caregivers of participants in the control group who agreed to receive daily text messages.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Acceptability | 15 Participants |
| Control Group | Acceptability | 5 Participants |
Primary
Comparison of Number and Percentage of Patients That Use Monitoring Device Over 30 Days (Feasibility)
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.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Comparison of Number and Percentage of Patients That Use Monitoring Device Over 30 Days (Feasibility) | 15 Participants |
| Control Group | Comparison of Number and Percentage of Patients That Use Monitoring Device Over 30 Days (Feasibility) | 17 Participants |
Secondary
Adherence
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)
Time frame: 30 days
Population: There are only 15 participants in the intervention group and 17 in the control group due to loss to follow up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Adherence | 34 percent adherence |
| Control Group | Adherence | 40 percent adherence |
Secondary
Change in Child Asthma Control Tool Score (cACT) From Baseline to End of Intervention Period.
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.
Time frame: 30 days
Population: There are only 15 participants in the intervention group and 17 in the control group due to loss to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Child Asthma Control Tool Score (cACT) From Baseline to End of Intervention Period. | 1.0 units on a scale | Standard Deviation 2.8 |
| Control Group | Change in Child Asthma Control Tool Score (cACT) From Baseline to End of Intervention Period. | 3.1 units on a scale | Standard Deviation 3 |