Asthma
Conditions
Brief summary
The goal of this study is to determine whether a sensor-enabled, clinically integrated, mobile health asthma program can improve asthma outcomes among 4-17 year old children with moderate-to-severe asthma.
Detailed description
Primary Aims: * Assess whether asthma control in patients enrolled in the intervention arm improved in comparison to the control arm through the (ACT) measurement tool. * Assess healthcare utilization (asthma-related ED visits and hospitalizations, asthma-related oral corticosteroid use) obtained through electronic medical record and parent report. Secondary Aims: Investigators will use parent-report surveys of the following psycho-social outcome measures: * Days missed from school due to asthma; 2) pediatric asthma-related quality of life (PACQLQ); and 3) Parental Asthma Management Self-Efficacy (PAMSE). * Enhance parental management through improved inhaler use. The investigators will use the Propeller Sensor Platform (referenced as Remote Health Management Platform) to allow parents to track their child's ICS and SABA inhaler use daily. The Platform also will have specific educational messaging to help parents and their children achieve adherence to their prescribed plan. This constant feedback and reinforcement may lead to improved asthma control therefore reducing frequency and severity of asthma exacerbations. The investigators will also be assessing the factors associated with the feasibility and sustainability of the Propeller Sensor Platform by observing trends in utilization. Utilization and drop-off will be measured by monitoring use of the inhalers and periodic surveys of families. * Improve management by the healthcare team. The investigators will use the Remote Health Management Platform to integrate inhaler use data into a web portal that the physician's office can access. Through the development of this interface, the Propeller Sensor Platform will be able to provide inhaler use feedback to healthcare teams. Types of feedback: * Emergency Management: data on inhaled corticosteroids (ICS) and short-acting beta-agonist (SABA) use * Long-term Management: data on ICS and SABA use. This interface will include data on both ICS and SABA inhaler use. The interface will also have flags to notify the office of under or overuse of inhalers, with a protocol in place to reach out to patients. The investigators will also be assessing the factors associated with the feasibility and sustainability of the Remote Health Management Platform by the healthcare team. This will be done by weekly contact with the healthcare team, rapid cycle improvement of the web portal, and written assessments.
Interventions
DEVICERemote Health Management Sensor Platform
The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.
Sponsors
Northwestern University
Dr. Deneen Vojta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* English-speaking parents * Children 4-\<17 years of age. Using both NHLBI (National Heart, Lung, and Blood Institute) guidelines and based off of a physician expert panel, the research team has limited the ages to 4-\<17 years old. It has been shown to be difficult to properly diagnose individuals less than 4 years of age with asthma. Usually, they are diagnosed with reactive airway disease or bronchial virus. Individuals \<17 years old was the oldest group because investigators wanted to avoid adolescence and make sure that parents have an active role in the health management of the child. * Moderate or severe persistent asthma, defined by the National Heart, Lung, and Blood Institute. This will be done by a physician-trained research assistant who will be able to identify potential participants prior to recruitment. * At least one asthma exacerbations that required a course of oral corticosteroids in the past year * Prescription and utilization of an ICS inhaler for at least the past year. * Who are seen at: Clark and Deming Resident Clinic, Lurie Children's Pulmonary Clinic, Lurie Children's Uptown Clinic, Chicago Family Asthma and Allergy Clinic or Children's Healthcare Associates
Exclusion criteria
* Non-English speaking parents/families * Patients seen in the hospital who receive primary care outside of the study's clinics * Children with any comorbid conditions, which interfere with appropriate assessment of asthma symptoms: Chronic Lung Disease, Broncho-Pulmonary Dysplasia, Cystic Fibrosis, Pulmonary Hypertension, Interstitial Lung Disease, Immunodeficiency, Bronchiectasis, Primary Ciliary Dyskinesia, Chronic Respiratory Insufficiency, Neuromuscular Weakness, Sickle Cell Lung Disease, Restrictive Lung Disease, and Tracheostomy or Ventilator-dependence * Child-patients who are participating in any other research studies that would interfere with our ability to use and track the inhaler sensor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Test (ACT) | 12 month follow-up assessment | Investigators will use the children's Asthma Control Test completed by the caregiver or parent to report child's asthma control. The ACT is a 5 item scale, with a 4-week recall (on symptoms and daily functioning) ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control via item-specific response options ranging from 1-5. Total ACT scores range from 5 (poorly controlled asthma, to 25 (well controlled asthma). |
| Frequency of Urgent Health Utilization | the 12 month study period | Number of Asthma-related ED visits during the 12 month study period |
| 12 Month Rate of Medication Use | Over a 12 month study period | Number of oral corticosteroid prescriptions obtained from the electronic medical record and parent/caregiver report |
| Frequency of Asthma-related Hospitalizations | the 12 month study period | Number of Asthma-related Hospitalizations during the 12 month study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire | 12 month study follow-up | The Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire was administered. This scale is a self-administered instrument, which includes 13 items (4 concern activity limitations and 9 concern emotional function). Responses to each item of the PACQLQ are given on a seven-point scale, ranging from 1 to 7, with the higher scores indicating less impairment. A total average score was calculated to reflect Pediatric Asthma Caregiver Quality of Life, which also ranged from 1-7. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management. | 125 |
| Control The control group will receive only standardized education. | 127 |
| Total | 252 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| ACT Score | 18.8 units on a scale STANDARD_DEVIATION 4.5 | 19.2 units on a scale STANDARD_DEVIATION 4.2 | 19.6 units on a scale STANDARD_DEVIATION 3.8 |
| Age, Categorical <=18 years | 125 Participants | 252 Participants | 127 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.3 Years STANDARD_DEVIATION 3.2 | 9.2 Years STANDARD_DEVIATION 3.3 | 9.2 Years STANDARD_DEVIATION 3.5 |
| Insurance Type Private Insurance % | 40 Percentage of participants | 42.8 Percentage of participants | 43.3 Percentage of participants |
| Insurance Type Public Insurance % | 59.2 Percentage of participants | 57.2 Percentage of participants | 56.7 Percentage of participants |
| PACQLQ | 5.7 units on a scale STANDARD_DEVIATION 1.3 | 5.8 units on a scale STANDARD_DEVIATION 1.2 | 5.8 units on a scale STANDARD_DEVIATION 1.1 |
| Race/Ethnicity, Customized Hispanic % | 40.0 Percentage of participants | 68.4 Percentage of participants | 28.4 Percentage of participants |
| Race/Ethnicity, Customized No Data % | 5.6 Percentage of participants | 12.7 Percentage of participants | 7.1 Percentage of participants |
| Race/Ethnicity, Customized Non-Hispanic/Black % | 23.2 Percentage of participants | 56.3 Percentage of participants | 33.1 Percentage of participants |
| Race/Ethnicity, Customized Non-Hispanic/White % | 24.0 Percentage of participants | 47.6 Percentage of participants | 23.6 Percentage of participants |
| Race/Ethnicity, Customized Other Race/Ethnicity % | 7.2 Percentage of participants | 15.0 Percentage of participants | 7.8 Percentage of participants |
| Region of Enrollment United States | 125 Participants | 252 Participants | 127 Participants |
| Sex: Female, Male Female | 44 Participants | 83 Participants | 39 Participants |
| Sex: Female, Male Male | 70 Participants | 156 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 125 | 0 / 127 |
| other Total, other adverse events | 0 / 125 | 0 / 127 |
| serious Total, serious adverse events | 0 / 125 | 0 / 127 |
Outcome results
Primary
12 Month Rate of Medication Use
Number of oral corticosteroid prescriptions obtained from the electronic medical record and parent/caregiver report
Time frame: Over a 12 month study period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | 12 Month Rate of Medication Use | 1.3 OCS Prescriptions | Standard Error 0.2 |
| Control | 12 Month Rate of Medication Use | .9 OCS Prescriptions | Standard Error 0.2 |
Primary
Asthma Control Test (ACT)
Investigators will use the children's Asthma Control Test completed by the caregiver or parent to report child's asthma control. The ACT is a 5 item scale, with a 4-week recall (on symptoms and daily functioning) ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control via item-specific response options ranging from 1-5. Total ACT scores range from 5 (poorly controlled asthma, to 25 (well controlled asthma).
Time frame: 12 month follow-up assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Asthma Control Test (ACT) | 21.8 units on a scale | Standard Error 0.4 |
| Control | Asthma Control Test (ACT) | 19.9 units on a scale | Standard Error 0.4 |
Primary
Frequency of Asthma-related Hospitalizations
Number of Asthma-related Hospitalizations during the 12 month study period
Time frame: the 12 month study period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Frequency of Asthma-related Hospitalizations | .4 Events (Asthma-related Hospitalizations) | Standard Error 0.1 |
| Control | Frequency of Asthma-related Hospitalizations | .1 Events (Asthma-related Hospitalizations) | Standard Error 0.06 |
Primary
Frequency of Urgent Health Utilization
Number of Asthma-related ED visits during the 12 month study period
Time frame: the 12 month study period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Frequency of Urgent Health Utilization | 1.0 events (asthma-related ED visits) | Standard Error 0.1 |
| Control | Frequency of Urgent Health Utilization | .6 events (asthma-related ED visits) | Standard Error 0.1 |
Secondary
Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire
The Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire was administered. This scale is a self-administered instrument, which includes 13 items (4 concern activity limitations and 9 concern emotional function). Responses to each item of the PACQLQ are given on a seven-point scale, ranging from 1 to 7, with the higher scores indicating less impairment. A total average score was calculated to reflect Pediatric Asthma Caregiver Quality of Life, which also ranged from 1-7.
Time frame: 12 month study follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire | 6.3 units on a scale | Standard Deviation 1 |
| Control | Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire | 6.0 units on a scale | Standard Deviation 1.4 |