Childhood Asthma Perception Study (CAPS)
Primary Purpose
Asthma, Childhood Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEF Feedback
Control Feedback
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Childhood Asthma, Bronchial Diseases, Immune System Diseases, Lung Diseases, Lung Diseases, Obstructive, Respiratory Tract Diseases, Peak Flow Meter, Symptom Perception, Illness Representation
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)
Sites / Locations
- Jacobi Medical Center
- Montefiore Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PEF Feedback
Control Feedback
Arm Description
This group will have 9 visits across 15 months.
This group will have 9 visits across 15 months.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Asthma Illness Representation Scale (AIRS)
37-item scale measuring risk factors for the underutilization of controller medications
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
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
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
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
Quantity of asthma-related emergency visits throughout the duration of the study
Asthma Control Test (C-ACT)
Self-report questionnaire for adolescents and parents
Full Information
NCT ID
NCT02702687
First Posted
February 25, 2016
Last Updated
February 3, 2023
Sponsor
Albert Einstein College of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT02702687
Brief Title
Childhood Asthma Perception Study
Acronym
CAPS
Official Title
Childhood Asthma Perception Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
July 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Childhood Asthma
Keywords
Asthma, Childhood Asthma, Bronchial Diseases, Immune System Diseases, Lung Diseases, Lung Diseases, Obstructive, Respiratory Tract Diseases, Peak Flow Meter, Symptom Perception, Illness Representation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
363 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEF Feedback
Arm Type
Experimental
Arm Description
This group will have 9 visits across 15 months.
Arm Title
Control Feedback
Arm Type
Active Comparator
Arm Description
This group will have 9 visits across 15 months.
Intervention Type
Behavioral
Intervention Name(s)
PEF Feedback
Intervention Description
Intervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education.
Intervention Type
Behavioral
Intervention Name(s)
Control Feedback
Intervention Description
Control feedback group will receive feedback consisting of standardized messages and have 3 control feedback visits and asthma education.
Primary Outcome Measure Information:
Title
Asthma Symptom Perception with Asthma Monitor (AM2) as percentage of guesses in the Under-Perception zone
Description
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)
Secondary Outcome Measure Information:
Title
Asthma Illness Representation Scale (AIRS)
Description
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)
Title
Asthma Management Self-Efficacy (ASE) scale: Parent and child versions
Description
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)
Title
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
Description
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)
Title
Medication Adherence - percentage of total doses taken per day/prescribed per day
Description
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)
Title
Health Care Use - Electronic Medical Record (EMR) review of asthma-related Emergency Department visits and hospitalizations
Description
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)
Title
Asthma Control Test (C-ACT)
Description
Self-report questionnaire for adolescents and parents
Time Frame
Change from Pre-intervention to 12-month-follow-up (15 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Feldman, PhD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Childhood Asthma Perception Study
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