AsthmaCAPSNCT02702687
Childhood Asthma Perception Study
A study testing PEF Feedback in people with Asthma and Childhood Asthma, run by Albert Einstein College of Medicine at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Asthma, Childhood Asthma
- What is being tested?
- PEF Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2016to 28 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 10-17 years of age
- Diagnosis of asthma (in medical record)
- Report of breathing problems within the past 12 months
- Prescribed a controller medication for asthma
- At least one parent self-identifies as Latino or Black
- The participating parent has primary or at least equal responsibility for the adolescent
Who cannot join
- Cognitive learning disability (parent report)
- No prescription for asthma controller medication
- Inability to perform acceptable PEF blows
- Race/ethnicity other than Latino or Black
- Other significant pulmonary conditions (cystic fibrosis)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jacobi Medical Center
The Bronx, New York, 10461
Montefiore Medical Center
The Bronx, New York, 10461
About this study
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.
Read the detailed description
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.
- Conditions
- Asthma, Childhood Asthma
- Being tested
- PEF Feedback, Control Feedback
- Keywords
- Asthma, Childhood Asthma, Bronchial Diseases, Immune System Diseases, Lung Diseases, Lung Diseases, Obstructive, Respiratory Tract Diseases, Peak Flow Meter, Symptom Perception, Illness Representation
- Medical subject headings
- Asthma, Bronchial Diseases, Immune System Diseases, Lung Diseases, Lung Diseases, Obstructive, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEF FeedbackBehavioural
Intervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education.
Control FeedbackBehavioural
Control feedback group will receive feedback consisting of standardized messages and have 3 control feedback visits and asthma education.
| Study group | Role | What they receive |
|---|---|---|
| PEF Feedback | Experimental | This group will have 9 visits across 15 months. Receives: Behavioral: PEF Feedback |
| Control Feedback | Active comparator | This group will have 9 visits across 15 months. Receives: Behavioral: Control Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Pre-intervention to 12-month-follow-up (15 months)
Secondary outcomes (6)
Asthma Illness Representation Scale (AIRS)
37-item scale measuring risk factors for the underutilization of controller medications
Measured: Change from Pre-intervention to 12-month-follow-up (15 months)
Asthma Management Self-Efficacy (ASE) scale: Parent and child versions
13-item scale measures parent's confidence in their ability to help manage child's asthma
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Pre-intervention to 12-month-follow-up (15 months)
Asthma Control Test (C-ACT)
Self-report questionnaire for adolescents and parents
Measured: Change from Pre-intervention to 12-month-follow-up (15 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startMay 2016
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jonathan Feldman, PhD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702687
- Sponsor's protocol ID
- 2014-3257
- Other IDs
- 1R01HL128260-01
- Acronym
- CAPS
- Status last verified
- Feb 2023
- First submitted
- 25 Feb 2016
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39454196
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Asthma Perception Study
- ClinicalTrials.gov ID
- NCT02702687
- Acronym / sponsor ID
- CAPS / 2014-3257
- Conditions
- Asthma, Childhood Asthma
- Keywords
- Asthma, Childhood Asthma, Bronchial Diseases, Immune System Diseases, Lung Diseases, Lung Diseases, Obstructive, Respiratory Tract Diseases, Peak Flow Meter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2016 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEF Feedback | Experimental | Behavioral: PEF FeedbackThis group will have 9 visits across 15 months. |
| Control Feedback | Active comparator | Behavioral: Control FeedbackThis group will have 9 visits across 15 months. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 10-17 years of age
- Diagnosis of asthma (in medical record)
- Report of breathing problems within the past 12 months
- Prescribed a controller medication for asthma
- At least one parent self-identifies as Latino or Black
Key exclusion criteria (5 listed)
- Cognitive learning disability (parent report)
- No prescription for asthma controller medication
- Inability to perform acceptable PEF blows
- Race/ethnicity other than Latino or Black
- Other significant pulmonary conditions (cystic fibrosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEF FeedbackIntervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education. | Behavioural | PEF Feedback |
| Control FeedbackControl feedback group will receive feedback consisting of standardized messages and have 3 control feedback visits and asthma education. | Behavioural | Control Feedback |
Primary outcome
Asthma Symptom Perception with Asthma Monitor (AM2) as percentage of guesses in the Under-Perception zone
Time frame: Change from Pre-intervention to 12-month-follow-up (15 months)
The percentage of times a child under-perceives the severity of asthma symptoms
6 secondary outcomes
Asthma Illness Representation Scale (AIRS)
Time frame: Change from Pre-intervention to 12-month-follow-up (15 months)
Asthma Management Self-Efficacy (ASE) scale: Parent and child versions
Time frame: Change from Pre-intervention to 12-month-follow-up (15 months)
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
Time frame: Change from Pre-intervention to 12-month-follow-up (15 months)
Medication Adherence - percentage of total doses taken per day/prescribed per day
Time frame: 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
Time frame: Change from Pre-intervention to 12-month-follow-up (15 months)
Asthma Control Test (C-ACT)
Time frame: Change from Pre-intervention to 12-month-follow-up (15 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Derived from this study: PubMed 39454196Feldman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Feldman, PhD principal investigator
Albert Einstein College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEF Feedback in people with Asthma and Childhood Asthma, run by Albert Einstein College of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Symptom Perception with Asthma Monitor (AM2) as percentage of guesses in the Under-Perception zone (time frame: Change from Pre-intervention to 12-month-follow-up (15 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02702687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.