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

NCT02671643 | Completed

• 1 other identifier: 14-1532
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Cohen's kappa

  To determine the agreement of the ACT score at the standard cutpoint of \>19 with physician assessment of control using Cohen's kappa.

  Baseline Visit

Secondary Outcomes (1)

• Sensitivity of ACT Questionnaire

  Six Weeks (Follow Up Visit)

Other Outcomes (2)

• Specificity of ACT Questionnaire

  Six Weeks (Follow Up Visit)

• Cohen's kappa

  Six Weeks (Follow Up Visit)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• American Academy of Allergy, Asthma, and Immunology: collaborator

Study Sites (2)

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599, United States

Location

NC Children's Specialty Clinic, 4414 Lake Boone Trail, Suite 505

Raleigh, North Carolina, 27607, United States

Location

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Related Links

• Ethnic Disparitites in the Burden and Treatment of Asthma
• American Lung Association; "State of Lung Disease in Diverse Communities 2010." www.lungusa.org; 2010; p1

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Michelle Hernandez, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 2, 2016
• Study Start: October 1, 2014
• Primary Completion: April 13, 2017
• Study Completion: June 1, 2017
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)