PEF Feedback
BehavioralIntervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education.
NCT Number: NCT02702687
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.
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Notify Me10 year–17 year
All sexes
Interventional
Not applicable
Jacobi Medical Center, The Bronx, New York, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education.
Control feedback group will receive feedback consisting of standardized messages and have 3 control feedback visits and asthma education.
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
Time frame: Change from Pre-intervention to 12-month-follow-up (15 months)
37-item scale measuring risk factors for the underutilization of controller medications
Time frame: Change from Pre-intervention to 12-month-follow-up (15 months)
13-item scale measures parent's confidence in their ability to help manage child's asthma
Time frame: Change from Pre-intervention to 12-month-follow-up (15 months)
23-item self report questionnaire assessing child's overall functioning in relation to asthma
Time frame: Change from Pre-intervention to 12-month-follow-up (15 months)
Self report of daily medication use, in relation to the prescribed use
Time frame: Change from Pre-intervention to 12-month-follow-up (15 months)
Quantity of asthma-related emergency visits throughout the duration of the study
Time frame: Change from Pre-intervention to 12-month-follow-up (15 months)
Self-report questionnaire for adolescents and parents
Albert Einstein College of Medicine
Other
Acronym: CAPS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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