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Childhood Asthma Perception Study (CAPS)

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ClinicalTrials.gov Identifier: NCT02702687
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : June 29, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jonathan Feldman, Albert Einstein College of Medicine

Tracking Information
First Submitted Date  ICMJE February 25, 2016
First Posted Date  ICMJE March 9, 2016
Last Update Posted Date June 29, 2020
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
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) ]
The percentage of times a child under-perceives the severity of asthma symptoms
Original Primary Outcome Measures  ICMJE
 (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) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
  • 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 - EMR review of asthma-related ED 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  ICMJE
 (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  ICMJE Childhood Asthma Perception Study
Official Title  ICMJE 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, NY. 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma
  • Childhood Asthma
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2016)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jonathan Feldman, PhD 646-592-4539 jonathan.feldman@einstein.yu.edu
Contact: Lynne Matte, PhD 646-592-4379 lynne.matte@einstein.yu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02702687
Other Study ID Numbers  ICMJE 2014-3257
1R01HL128260-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jonathan Feldman, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Jonathan Feldman, PhD Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP