Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

To Determine the Measurement Properties of the ACT in an African American Adolescent Population With Persistent Asthma (ACT AA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671643
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : March 23, 2018
Sponsor:
Collaborator:
American Academy of Allergy, Asthma, and Immunology
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
Purpose: To determine the measurement properties of the asthma control test (ACT) in a prospective clinical study in an African American adolescent population.

Condition or disease
Asthma

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Determine the Measurement Properties of the ACT in an African American Adolescent Population With Persistent Asthma Followed at a Subspecialty Clinic
Study Start Date : October 2014
Actual Primary Completion Date : April 13, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Cohen's kappa [ Time Frame: Baseline Visit ]
    To determine the agreement of the ACT score at the standard cutpoint of >19 with physician assessment of control using Cohen's kappa.


Secondary Outcome Measures :
  1. Sensitivity of ACT Questionnaire [ Time Frame: Six Weeks (Follow Up Visit) ]
    A receiver-operating curve will be used to determine the best ACT cutpoint for assessment of control in this population. A logistic regression model will be used with 'control by physician' as the dependent variable and 'ACT score' as the independent variable. The model will include adjustment for repeated measures (baseline and 6 week visit).


Other Outcome Measures:
  1. Specificity of ACT Questionnaire [ Time Frame: Six Weeks (Follow Up Visit) ]
    A receiver-operating curve will be used to determine the best ACT cutpoint for assessment of control in this population. A logistic regression model will be used with 'control by physician' as the dependent variable and 'ACT score' as the independent variable. The model will include adjustment for repeated measures (baseline and 6 week visit).

  2. Cohen's kappa [ Time Frame: Six Weeks (Follow Up Visit) ]
    To determine the agreement of the ACT score at the standard cutpoint of >19 with physician assessment of control using Cohen's kappa.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
80 African-American adolescents ages 12-18 with a physician diagnosis of persistent asthma. These adolescents are followed at the UNC Asthma Clinic seen by either pediatric pulmonologists or allergists.
Criteria

Inclusion Criteria:

  • Self-identified as African-American
  • Ages 12-18 years
  • Live within convenient driving distance of the NC Children's Specialty Clinic in Raleigh, NC.
  • Physician-diagnosis of persistent asthma
  • Current treatment with appropriate therapy for persistent asthma symptoms as per the NHLBI guidelines including: Daily controller medication use for asthma requiring at least low-dose inhaled corticosteroids (ICS). Asthma may range from mild persistent through severe persistent asthma, to include subjects that may require daily or every other day oral corticosteroids for control of asthma symptoms

Exclusion Criteria:

  • Children younger than age 12 and older than 18
  • Children unable to perform spirometry
  • Medical history or underlying health problems that may preclude participation in the protocol per the study physician (including but not limited to cystic fibrosis, chronic bronchitis, recurrent pneumonia, immunodeficiency, hematologic disorders)
  • Subjects and families unwilling to travel to the clinic for the required 2 visits
  • Other uncontrolled health problems
  • Non-English speaking subjects

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): NCT02671643


Locations
Layout table for location information
United States, North Carolina
UNC Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, United States, 27599
NC Children's Specialty Clinic, 4414 Lake Boone Trail, Suite 505
Raleigh, North Carolina, United States, 27607
Sponsors and Collaborators
University of North Carolina, Chapel Hill
American Academy of Allergy, Asthma, and Immunology
Investigators
Layout table for investigator information
Principal Investigator: Michelle Hernandez, MD University of North Carolina, Chapel Hill
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02671643    
Other Study ID Numbers: 14-1532
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases