Childhood Asthma Perception Study (CAPS)

• ClinicalTrials.gov Identifier: NCT02702687
• Recruitment Status: Completed
• First Posted: March 9, 2016
• Last Update Posted: February 6, 2023
• Sponsor: Albert Einstein College of Medicine
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Albert Einstein College of Medicine

Tracking Information

• First Submitted Date: February 25, 2016
• First Posted Date: March 9, 2016
• Last Update Posted Date: February 6, 2023
• Actual Study Start Date: May 2016
• Actual Primary Completion Date: July 28, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 25, 2022)

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

• Original Primary Outcome Measures (submitted: March 3, 2016): Asthma Symptom Perception with AM2 as percentage of guesses in the Under-Perception zone [ Time Frame: Change from Pre-intervention to 12-month-follow-up (15 months) ]

Current Secondary Outcome Measures (submitted: May 25, 2022)

• Asthma Illness Representation Scale (AIRS) [ 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
• Asthma Management Self-Efficacy (ASE) scale: Parent and child versions [ 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
• Pediatric Asthma Quality of Life Questionnaire (PAQLQ) [ 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
• 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) ]
  Self report of daily medication use, in relation to the prescribed use
• 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) ]
  Quantity of asthma-related emergency visits throughout the duration of the study
• Asthma Control Test (C-ACT) [ Time Frame: Change from Pre-intervention to 12-month-follow-up (15 months) ]
  Self-report questionnaire for adolescents and parents

Original Secondary Outcome Measures (submitted: March 3, 2016)

• 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) ]
  13-item scale measures parent's confidence in their ability to help manage child's asthma
• 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 - EMR review of asthma-related ED 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) ]
  Self-report questionnaire for adolescents and parents

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Childhood Asthma Perception Study
• Official Title: Childhood Asthma Perception Study
• Brief 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. 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Asthma
• Childhood Asthma

Intervention

• Behavioral: PEF Feedback
  Intervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education.
• Behavioral: Control Feedback
  Control feedback group will receive feedback consisting of standardized messages and have 3 control feedback visits and asthma education.

Study Arms

• Experimental: PEF Feedback
  This group will have 9 visits across 15 months.
  Intervention: Behavioral: PEF Feedback
• Active Comparator: Control Feedback
  This group will have 9 visits across 15 months.
  Intervention: Behavioral: Control Feedback

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 4, 2020): 363
• Original Estimated Enrollment (submitted: March 3, 2016): 260
• Actual Study Completion Date: July 28, 2022
• Actual Primary Completion Date: July 28, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 10 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02702687
• Other Study ID Numbers: 2014-3257; 1R01HL128260-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Albert Einstein College of Medicine
• Original Responsible Party: Jonathan Feldman, Albert Einstein College of Medicine, Professor of Psychology
• Current Study Sponsor: Albert Einstein College of Medicine
• Original Study Sponsor: Same as current
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Jonathan Feldman, PhD; Albert Einstein College of Medicine

• PRS Account: Albert Einstein College of Medicine
• Verification Date: February 2023