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Trial record 8 of 90 for:    asthma | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Childhood Asthma Perception Study (CAPS)

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ClinicalTrials.gov Identifier: NCT02702687
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jonathan Feldman, Albert Einstein College of Medicine, Inc.

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.

Condition or disease Intervention/treatment Phase
Asthma Childhood Asthma Behavioral: PEF Feedback Behavioral: Control Feedback Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Childhood Asthma Perception Study
Study Start Date : May 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: PEF Feedback
This group will have 9 visits across 15 months.
Behavioral: PEF Feedback
Intervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education.

Active Comparator: Control Feedback
This group will have 9 visits across 15 months.
Behavioral: Control Feedback
Control feedback group will receive feedback consisting of standardized messages and have 3 control feedback visits and asthma education.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702687


Contacts
Contact: Jonathan Feldman, PhD 646-592-4539 jonathan.feldman@einstein.yu.edu
Contact: Lynne Matte, PhD 646-592-4379 lynne.matte@einstein.yu.edu

Locations
United States, New York
Jacobi Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Denise Serebrisky, MD    718-918-6984    denise.serebrisky@nbhn.net   
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Karen Warman, MD    718-405-8090    KWARMAN@montefiore.org   
Sub-Investigator: Deepa Rastogi, MBBS         
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jonathan Feldman, PhD Albert Einstein College of Medicine, Inc.

Responsible Party: Jonathan Feldman, Professor of Psychology, Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier: NCT02702687     History of Changes
Other Study ID Numbers: 2014-3257
1R01HL128260-01 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jonathan Feldman, Albert Einstein College of Medicine, Inc.:
Asthma
Childhood Asthma
Bronchial Diseases
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Peak Flow Meter
Symptom Perception
Illness Representation

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases