CLINICAL TRIAL

Usual care for Asthma

Recruiting · Any Age · All Sexes · Lancaster, SC

This study is evaluating whether a mobile phone app can help improve adherence to asthma medication for children in rural South Carolina.

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About the trial for Asthma

Treatment Groups

This trial involves 2 different treatments. Usual Care is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
AsthmaMD mobile application
DEVICE
Experimental Group 2
Usual care
OTHER

Eligibility

This trial is for patients born any sex of any age. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
1) children self/family-identified as Hispanic or Latino, 2) school-aged (5-12 years) and attends school within the Lancaster County School District, 3) has received a diagnosis of asthma from a health care provider and is taking a controller medication, and 4) parents/primary caregiver (e.g., grandparents, extended family) language of preference is Spanish
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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: 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
View detailed reporting requirements
Trial Expert
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- 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 Usual care will improve 3 primary outcomes and 1 secondary outcome in patients with Asthma. Measurement will happen over the course of 1 week.

Mobile app usability and acceptability
1 WEEK
Participants with Spanish as first language use the translated app for ease of use and identification of interface problems
1 WEEK
Preliminary protocol testing of mobile app-facilitated triadic communication
3 MONTHS
Develop and evaluate a triadic, patient-centered asthma intervention preliminary protocol, facilitated by the Spanish language mobile app. Post-intervention data regarding the experiences of the participants in this collaborative intervention will be obtained through a post-intervention focus group facilitated by the PI with the PCPs and school nurses, and five interviews conducted by a bilingual research assistant with the Latino families.
3 MONTHS
Medication adherence and lung function tests
6 MONTHS
Secondary outcome measures include frequency of rescue inhaler use, as well as asthma exacerbations, outpatient clinic visits, and emergency department visits. Lung capacity will be obtained pre- and post-intervention/bronchodilation using spirometry49 to obtain relevant lung function variables such as FEV1 and FEV1/FVC. Measures from the control group will include medication counts, number of asthma exacerbations, ED/outpatient clinic visits, and spirometry measures on enrollment, during the intervention phase, and again at the end of the intervention.
6 MONTHS
Investigate the feasibility of the patient-centered asthma intervention
6 MONTHS
Investigate the feasibility of the patient-centered asthma intervention from aim 2 using a wait list randomized control trial (RCT) to investigate the effects of the intervention on school days missed and medication adherence. Anticipated quantitative data includes the information entered into the app, encrypted, and transmitted to the school nurse by the parent/caregiver. These data will include selected NIH/AHRQ standardized asthma outcomes,47 including the primary outcome measures of medication adherence information (asthma medication ratio48 - predictive of childhood asthma ED visits and hospitalizations) and school days missed.
6 MONTHS

Who is running the study

Principal Investigator
R. D.
Prof. Robin Dawson, Associate Professor
University of South Carolina

Patient Q & A Section

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

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

About 8 million people in the United States currently have asthma. The Centers for Disease Control and Prevention estimates that at least 10,000 new cases of asthma and 15,000 deaths occur annually in American women and men.

Anonymous Patient Answer

What are common treatments for asthma?

Many adults with asthma have a variety of co-morbidities, making asthma management difficult. However, a number of effective medications can be prescribed, and patient education and referral to specialty providers are common strategies for managing asthma.

Anonymous Patient Answer

What is asthma?

Asthma is a common breathing difficulty characterized by intermittent airway obstruction due to inflammation, airway remodelling and variable airflow limitation. Asthma often begins in childhood with an increased respiratory vulnerability and may be the first manifestation of asthma in many people. It is highly variable in its effects but can be severely debilitating when uncontrolled.

Anonymous Patient Answer

Can asthma be cured?

The best available evidence suggests that the risk of death associated with asthma is largely due to the underlying disease, rather than some characteristic of the disease that is controllable. However, recent studies have shown that asthma can be cured, and in fact many patients benefit from anti-inflammatory treatment.

Anonymous Patient Answer

What causes asthma?

Many factors, such as age, smoking, and allergic disease increase the risk of developing asthma. However, in some cases the underlying factor is genetic susceptibility. Most people with asthma have a combination of triggers and susceptibility.\n

Anonymous Patient Answer

What are the signs of asthma?

Asthma was often under-recognised until the presentation of children to the paediatric emergency department, or even after admission to hospital. The classic signs are wheezing, shortness of breath and coughing up blood. It is important to understand the underlying signs/symptoms of asthma as children with little/no symptoms may present acutely with asthma if they can't breathe enough air.

Anonymous Patient Answer

Who should consider clinical trials for asthma?

Physicians have a responsibility to promote and educate patients as to clinical trials. Patients may feel less anxious if they are informed that the benefits of pharmaceutical treatments outweigh the risks. The process of informed consent regarding clinical trials is simple, and patient-centric approaches to care make clinical trials more acceptable. Physicians must promote patient-centered clinical trials as they continue to provide patients with the most current evidence on treatment options.

Anonymous Patient Answer

What are the latest developments in usual care for therapeutic use?

Current usual care for patients with asthma is suboptimal and involves only a small part of the patient's symptomatology. At present, we recommend increasing the use of usual care interventions, especially for people with more severe symptoms.

Anonymous Patient Answer

What is the primary cause of asthma?

Asthma can be prevented and controlled by reducing dietary, physical, and psychosocial factors. The most serious factors are smoking, obesity, and environmental irritants, such as dust and air pollution.

Anonymous Patient Answer

Has usual care proven to be more effective than a placebo?

Although the group with usual care did not lose more weight than those on placebo, the weight gain seen was a better reflection of the weight loss they were able to achieve. This is because weight gain can only follow weight loss. For BMI > 35 to decrease, other factors have to be targeted, such as the high fat density diet.

Anonymous Patient Answer

What is usual care?

Although the majority of healthcare professionals were satisfied with the current level of care, some felt that a more integrated model of outpatient asthma management was needed. One aspect that needs greater integration is improving the quality of the patients’ lifestyle, including lifestyle advice.

Anonymous Patient Answer

Is usual care typically used in combination with any other treatments?

Few patients received ICS therapy alone or with other treatments. This was particularly true for patients who had been prescribed a LABA. This finding suggests that clinicians may be missing opportunities to improve asthma outcomes by using effective combinations of therapy to reduce exacerbations and improve lung function and QoL.

Anonymous Patient Answer
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