CLINICAL TRIAL

Daily Adherence Reminders/Adherence Performance Feedback for Asthma

Waitlist Available · < 18 · All Sexes · Philadelphia, PA

This study is evaluating whether financial incentives can help improve adherence to inhaled corticosteroids for children with asthma.

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About the trial for Asthma

Eligible Conditions
Asthma in Children · Adherence, Medication · Asthma

Treatment Groups

This trial involves 2 different treatments. Daily Adherence Reminders/Adherence Performance Feedback is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Nominal Financial Incentives
OTHER
Daily Adherence Reminders/Adherence Performance Feedback
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Daily Adherence Reminders/Adherence Performance Feedback
OTHER

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People between the ages of 5 and 12, along with a parent or legal guardian, are eligible to take part in this study. show original
The caregiver has an enabled cellular phone, which most likely means that it is a smartphone show original
A corticosteroid inhaler is prescribed for daily use to help control asthma symptoms show original
The person has had at least two asthma exacerbations in the preceding year show original
Your parents/guardians need to give permission (informed consent) before you can participate in this study, and if you are under 18, you will need to assent to participate. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Daily Adherence Reminders/Adherence Performance Feedback will improve 1 primary outcome and 4 secondary outcomes in patients with Asthma. Measurement will happen over the course of 6 months.

Adherence to ICS regime
6 MONTHS
Calculated as the mean daily proportion of prescribed doses taken by study month. Days that reflect >1 will be truncated to 1.
6 MONTHS
Adherence trajectory
6 MONTHS
Calculate group-based modeling of adherence patterns
6 MONTHS
Number of asthma-related emergency room visits, hospitalizations and oral steroid courses
12 MONTHS
Calculate and compare the number of asthma-related emergency room visits, hospitalizations and oral steroid courses between study arms.
12 MONTHS
Healthcare costs of utilization
12 MONTHS
Calculate the costs associated with emergency room utilization, hospital utilization and oral steroid course prescription between study arms.
12 MONTHS
Changes in Child Asthma Control Tool (cACT) score
12 MONTHS
Assess the cACT score at multiple time points and evaluate the changes in score from first study visit to the second, third, fourth, and fifth study visits. The Child Asthma Control Tool (cACT) score ranges from 0 (poor control) to 27 (complete control). The greater the value, the higher the control. The larger the difference (larger magnitude) of the value in the differences between the scores, the greater the improvement in controlling the child's asthma diagnosis.
12 MONTHS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for asthma?

Asthma and COPD are common and treatable diseases. Effective symptom control and preventive care decrease disability and improve lung function. Corticosteroids can help in some patients' control of their symptoms, while in others, inhaled corticosteroids may not be the first choice of treatment.

Anonymous Patient Answer

How many people get asthma a year in the United States?

Symptoms of asthma occur at least four times in the course of a year in at least 15% of the US population. At least 1.6 million people have symptoms of asthma that require urgent medical or surgical intervention annually. To this end, the National Institute of Allergy and Infectious Disease (NIAID) has committed an NIH-wide effort to address health disparities. The goal of this effort is to integrate research to improve the overall care of persons with asthma or related disorders in the United States.

Anonymous Patient Answer

What is asthma?

Approximately 30% of children in developed countries suffer from asthma at least once in their lives. Approximately 1 billion people will suffer from asthma in the developed world by 2005 and 20% of all deaths will be due to asthma. Asthma is a long term disorder, as is nearly 70% of all deaths caused by it.

Anonymous Patient Answer

What are the signs of asthma?

Asthma is a common problem all over the world. People affected by it experience symptoms that are non-specific, vague and vague, difficult to distinguish from other conditions. The severity of asthma decreases with awareness. Most people with asthma know their asthma does not necessarily affect their quality of life. Clinicians should be aware of asthma symptoms. They should be aware that even mildly symptomatic cases may be under-diagnosed. Patients are often unaware of the nature of asthma and what would help them to live longer and in the end better.

Anonymous Patient Answer

Can asthma be cured?

There seems to be a trend towards remission after asthma control. The role of alternative treatment regimens is still under-researched. There is still a need to increase asthma research to enable evidence-based treatment decisions to be made.

Anonymous Patient Answer

What causes asthma?

There have not been many specific risk factors identified for asthma and the disease remains poorly understood. Though it is often said that the 'house dust mite hypothesis' predicts the development of asthma, the data suggest that environmental triggers of asthma other than indoor allergens may contribute to asthma aetiology.

Anonymous Patient Answer

What are the latest developments in daily adherence reminders/adherence performance feedback for therapeutic use?

The following systems may serve as reminders if used appropriately to promote adherence:\n- Wearable devices by patients\n- Patient self-monitoring\n- Patient reminders from health care providers that are given when patients are due reminders (e.g., clinic visits) or when patients request to have missed reminders\n- Electronic monitoring of adherence via a clinical decision support system. This requires a clinician to be in the room at a reminder event but can be useful as another deterrent to poor adherence.

Anonymous Patient Answer

Is daily adherence reminders/adherence performance feedback safe for people?

The use of daily reminders or performance feedback had no difference in adherence, and may not be safe at this dose in this population. Adherence counseling increased adherence, however, it may not be the most important factor.

Anonymous Patient Answer

What is the average age someone gets asthma?

Most estimates are higher than the actual incidence of asthma in the United States: about 6% have asthma at age 15 and nearly 14% of adults have asthma. However, age adjusted asthma rates have been decreasing in the United States.

Anonymous Patient Answer

What is the primary cause of asthma?

The most common causes of asthma are allergy, tobacco smoking, air pollution, and the presence of parasitic infections. The presence of these causes may worsen and/or initiate asthma attacks.

Anonymous Patient Answer

Have there been any new discoveries for treating asthma?

This is not so surprising because more than one in ten people with asthma would need treatment to manage the symptoms of the disease. This is especially true among children, for whom asthma can severely impair quality of life, with an average of five days lost from school and three days lost from work in the U.S., and this number is substantially lower in Europe in the absence of controller medicines.

Anonymous Patient Answer
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