AsthmaNCT02615743
Asthma Controller Adherence After Hospitalization
A study testing Daily Text message reminder and Inhaled steroid canister monitor in people with Asthma, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Daily Text message reminder and Inhaled steroid canister monitor
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Daily Text message reminder, Inhaled steroid canister monitor
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Text message reminderBehavioural
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 monitorDevice
Also called Propeller Health Bluetooth Low Energy (BLE) Sensor
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Daily Text message reminder; Device: Inhaled steroid canister monitor |
| Control Group | Other | 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. Receives: Device: Inhaled steroid canister monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
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.
Measured: 30 days (intervention group) 60 days (control group)
Secondary outcomes (2)
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)
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startDec 2015
- Primary completion20 Sep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Chen C Kenyon, MD, MS, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615743
- Sponsor's protocol ID
- 15-012092
- Status last verified
- Apr 2019
- First submitted
- 23 Nov 2015
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 28347975
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Adherence Feedback for High Risk Children With Asthma
- ClinicalTrials.gov ID
- NCT02615743
- Acronym / sponsor ID
- 15-012092
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- Dec 2015
- Primary completion
- 20 Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Posted 31 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Daily Text message reminder, Device: Inhaled steroid canister monitorCaregivers 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. |
| Control Group | Other | Device: Inhaled steroid canister monitorCaregivers 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. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Text message reminderSubjects 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. | Behavioural | Intervention Group |
| Inhaled steroid canister monitorAlso: Propeller Health Bluetooth Low Energy (BLE) SensorAn 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. | Device | Control Group, Intervention Group |
Primary outcome
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.
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.
2 secondary outcomes
Adherence
Time frame: 30 days
Change in Child Asthma Control Tool Score (cACT) From Baseline to End of Intervention Period.
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28347975Adams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen C Kenyon, MD, MS principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Text message reminder and Inhaled steroid canister monitor in people with Asthma, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Number and Percentage of Patients That Use Monitoring Device Over 30 Days (Feasibility) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02615743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.