Women of Color and Asthma Control

NCT01117805 | Completed DMC

• 1 other identifier: 1R18HL094272-01
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed randomized controlled trial will evaluate an innovative intervention in 420 African American women with asthma. It will be the first to use a highly tailored, telephone counseling approach to address both specific cultural factors affecting asthma and the influence of female sex and gender on control.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (3)

• Emergency department visits - 1st time point

  We will collect health care utilization data related to asthma. Women in the study will be asked during their baseline telephone interview to provide information regarding the frequency of Emergency Department visits related to asthma during the year prior to the baseline interview. Second, women's CareWeb and billing records will be reviewed for asthma related ED visits during this time period.

  12months prior to baseline interview

• Emergency Department Visits -2nd time point

  We will collect health care utilization data related to asthma. Women in the study will be asked during the SECOND TELEPHONE INTERVIEW to provide information regarding the frequency of Emergency Department visits related to asthma for their year between their baseline and 12month interview. In addition, we will review their CareWeb and billing record data for that time period to see if there are any asthma related Emergency Department visits.

  Interval between baseline interview and 12 month interview

• Emergency Department Visits - 3rd time point

  We will collect health care utilization data related to asthma. Women in the study will be asked during the THIRD TELEPHONE INTERVIEW to provide information regarding the frequency of Emergency Department visits related to asthma for their year between their 12 month and 24 month telephone interview. In addition, we will review their CareWeb and billing record data for that time period to see if there are any asthma related Emergency Department visits.

  Interval between 12 month and 24 month telephone interview

Secondary Outcomes (3)

• Hospitalizations - first time point

  Year prior to baseline interview

• Hospitalizations related to asthma - 2nd time point

  interval between baseline and 12 month interview

• Hospitalizations related to asthma - 3rd time point

  interval between 12month and 24 month telephone interview

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Subjects will be randomized to the program intervention which is a female-specific, culturally relevant, self-regulation based telephone counseling intervention designed for African American women with asthma.

Behavioral: Telephone counseling intervention

usual care

NO INTERVENTION

Usual care at the University of Michigan Health System is based on the guidelines as recommended by the National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP-EPR3): Diagnosis and Treatment of Asthma and is coordinated so that all patients receive the same action plan, educational materials and instructions in use of devices.

Interventions

Telephone counseling intervention BEHAVIORAL

self-regulation telephone counseling program for African American women with asthma

Also known as: Women Breathe Free

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study participants will be a non-institutionalized ambulatory sample of women who are willing to participate in the project and meet the following criteria:
• Self-identify as African-American
• years of age or older
• Are listed on the University of Michigan Health System (UMHS) Asthma Patient Registry, a validated, all-payer registry of patients with persistent asthma cared for within the UM Health System
• Have access to a telephone or cell phone
• Are not pregnant.. Because the UMHS Asthma Patient Registry is validated, there is minimal risk of diagnostic misclassification. The Registry is created and maintained with a two-step process of identification and validation. UMHS patients with persistent asthma are initially identified through the electronic medical record using National Committee for Quality Assurance (NCQA) Healthcare Effectiveness Data and Information Set (HEDIS) criteria, billing and claims data (when available), and then are validated using documented clinical diagnoses, pulmonary function test (PFT) results, or clinician review.

You may not qualify if:

• Patients with chronic respiratory conditions, including cystic fibrosis and chronic obstructive pulmonary disease (COPD) are excluded

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Public Health

Ann Arbor, Michigan, 48109-2029, United States

Location

Related Publications (2)

• Patel MR, Song PX, Sanders G, Nelson B, Kaltsas E, Thomas LJ, Janevic MR, Hafeez K, Wang W, Wilkin M, Johnson TR, Brown RW. A randomized clinical trial of a culturally responsive intervention for African American women with asthma. Ann Allergy Asthma Immunol. 2017 Feb;118(2):212-219. doi: 10.1016/j.anai.2016.11.016. Epub 2016 Dec 27.

  PMID: 28034579 DERIVED

• Janevic MR, Sanders GM, Thomas LJ, Williams DM, Nelson B, Gilchrist E, Johnson TR, Clark NM. Study protocol for Women of Color and Asthma Control: a randomized controlled trial of an asthma-management intervention for African American women. BMC Public Health. 2012 Jan 24;12:76. doi: 10.1186/1471-2458-12-76.

  PMID: 22272780 DERIVED

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

• Noreen M. Clark, PhD

  University of Michigan School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 10, 2016

Record last verified: 2016-06

Locations

US (1)