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| Name | Class |
|---|---|
| Northwestern University | OTHER |
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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.
Primary Aims:
Secondary Aims:
Investigators will use parent-report surveys of the following psycho-social outcome measures:
Types of feedback:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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). |
|
| Control | No Intervention | The control group will receive only standardized education. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Health Management Sensor Platform | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 month follow-up assessment |
| Frequency of Urgent Health Utilization | Number of Asthma-related ED visits during the 12 month study period | the 12 month study period |
| 12 Month Rate of Medication Use | Number of oral corticosteroid prescriptions obtained from the electronic medical record and parent/caregiver report | Over a 12 month study period |
| Frequency of Asthma-related Hospitalizations | Number of Asthma-related Hospitalizations during the 12 month study period | the 12 month study period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33386336 | Derived | Gupta RS, Fierstein JL, Boon KL, Kanaley MK, Bozen A, Kan K, Vojta D, Warren CM. Sensor-Based Electronic Monitoring for Asthma: A Randomized Controlled Trial. Pediatrics. 2021 Jan;147(1):e20201330. doi: 10.1542/peds.2020-1330. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | The control group will receive only standardized education. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Error | units on a scale | 12 month follow-up assessment |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathy Boon- Clinical Research Associate | Northwestern University | 312-503-4687 | kathy.boon@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 6, 2020 | Jul 26, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2020 | Jul 26, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
|
| 12 month study follow-up |
| BG001 | Control | The control group will receive only standardized education. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | some patients did not choose to identify sex as either male or female | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Percentage of participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Insurance Type | Number | Percentage of participants |
|
| ACT Score | 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). | Mean | Standard Deviation | units on a scale |
|
| PACQLQ | 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Control | The control group will receive only standardized education. |
|
|
| Primary | Frequency of Urgent Health Utilization | Number of Asthma-related ED visits during the 12 month study period | Posted | Mean | Standard Error | events (asthma-related ED visits) | the 12 month study period |
|
|
|
| Primary | 12 Month Rate of Medication Use | Number of oral corticosteroid prescriptions obtained from the electronic medical record and parent/caregiver report | Posted | Mean | Standard Error | OCS Prescriptions | Over a 12 month study period |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 12 month study follow-up |
|
|
|
| Primary | Frequency of Asthma-related Hospitalizations | Number of Asthma-related Hospitalizations during the 12 month study period | Posted | Mean | Standard Error | Events (Asthma-related Hospitalizations) | the 12 month study period |
|
|
|
| 0 |
| 125 |
| 0 |
| 125 |
| 0 |
| 125 |
| EG001 | Control | The control group will receive only standardized education. | 0 | 127 | 0 | 127 | 0 | 127 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |