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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL128260-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This randomized controlled trial will include Latino and Black adolescents with asthma ages 10-17 years old and their caregivers. Participants will be recruited from clinics in the Bronx, New York. The primary aims are to examine the efficacy of peak expiratory flow (PEF) prediction with feedback versus control feedback on 1) under-perception of asthma symptoms 2) controller medication adherence and 3) asthma control and emergency health care use. These aims will be examined across a 1-year follow-up. An exploratory aim examines the hypothesized pathway that the PEF intervention reduces under-perception of symptoms, shifts illness representations toward the professional model and increases adolescents' and parents' asthma management self-efficacy, resulting in greater medication adherence and improved asthma control.
Under-perception of asthma symptoms in children is a major risk factor for emergency department visits, hospitalizations, and near-fatal/fatal asthma attacks. Puerto Rican and Black children have greater asthma morbidity and mortality rates than all other racial/ethnic groups. Interventions targeting asthma symptom perception and medication adherence may help close this asthma health disparities gap.
The baseline visit for all families consists of standardized asthma education followed by 3 weeks of PEF prediction without feedback using a programmable, electronic spirometer. Participants then will be randomized to intervention group or control feedback group and receive a brief feedback session. For the next 6 weeks, all adolescents will predict their PEF, which will be locked in before blowing into the device. Families will return at mid-intervention and post-intervention to receive feedback sessions. All adolescents will play an interactive asthma educational game to reinforce the baseline asthma education. At the post-intervention visit, the spirometer will be reprogrammed for the next 4 weeks. These symptom perception data will be downloaded at 1-month post-intervention. Controller medication adherence will be monitored by electronic devices. Post-intervention sessions will take place at 3, 6, 9, and 12 months to collect adherence data and conduct spirometry. Physicians will be blinded to group assignment and rate asthma severity using national guidelines. A 12-month retrospective medical record abstraction will compare emergency health care use for asthma between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEF Feedback | Experimental | This group will have 9 visits across 15 months. |
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| Control Feedback | Active Comparator | This group will have 9 visits across 15 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEF Feedback | Behavioral | Intervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education. |
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| Measure | Description | Time Frame |
|---|---|---|
| Asthma Symptom Perception with Asthma Monitor (AM2) as percentage of guesses in the Under-Perception zone | The percentage of times a child under-perceives the severity of asthma symptoms | Change from Pre-intervention to 12-month-follow-up (15 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Illness Representation Scale (AIRS) | 37-item scale measuring risk factors for the underutilization of controller medications | Change from Pre-intervention to 12-month-follow-up (15 months) |
| Asthma Management Self-Efficacy (ASE) scale: Parent and child versions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Feldman, PhD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobi Medical Center | The Bronx | New York | 10461 | United States | ||
| Montefiore Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39454196 | Derived | Feldman JM, Rastogi D, Warman K, Serebrisky D, Arcoleo K. Peak Flow Feedback Intervention Improves Underperception of Airflow Limitation in Pediatric Asthma: A Randomized Clinical Trial. Ann Am Thorac Soc. 2025 Mar;22(3):403-415. doi: 10.1513/AnnalsATS.202406-637OC. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 12, 2020 | Oct 12, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D007154 | Immune System Diseases |
| D008171 | Lung Diseases |
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| Control Feedback | Behavioral | Control feedback group will receive feedback consisting of standardized messages and have 3 control feedback visits and asthma education. |
|
13-item scale measures parent's confidence in their ability to help manage child's asthma |
| Change from Pre-intervention to 12-month-follow-up (15 months) |
| Pediatric Asthma Quality of Life Questionnaire (PAQLQ) | 23-item self report questionnaire assessing child's overall functioning in relation to asthma | Change from Pre-intervention to 12-month-follow-up (15 months) |
| Medication Adherence - percentage of total doses taken per day/prescribed per day | Self report of daily medication use, in relation to the prescribed use | Change from Pre-intervention to 12-month-follow-up (15 months) |
| Health Care Use - Electronic Medical Record (EMR) review of asthma-related Emergency Department visits and hospitalizations | Quantity of asthma-related emergency visits throughout the duration of the study | Change from Pre-intervention to 12-month-follow-up (15 months) |
| Asthma Control Test (C-ACT) | Self-report questionnaire for adolescents and parents | Change from Pre-intervention to 12-month-follow-up (15 months) |
| The Bronx |
| New York |
| 10461 |
| United States |