Helping Chicago's Westside Adults Breathe and Thrive

NCT03489655 | Unknown

• 1 other identifier: ILHHU0029-15
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

Adults with asthma living in Chicago's West and Southwest side who completed the home-based Community Health Worker (CHW) intervention called Helping Chicago's Westside Adults Breathe and Thrive (HCWABT I) after October 2015 were eligible to participate in a randomized control trial called HCWABT II, which will evaluate the long-term impact of the intervention on their asthma control, asthma severity, healthcare use, and asthma-related quality of life. Participants are randomly assigned to an intervention arm, where they continue to receive occasional (monthly or bimonthly) contact from the CHW who served them during HCWABT I. or a control arm, where they no longer receive contact from the CHW. Members of both groups receive monthly data collection calls from a Research Assistant. We hypothesize that participants in the control arm will experience sustained improvements in asthma outcomes as compared to their pre-HCWABT I levels and that participants in the CHW intervention arm will continue to improve in asthma control severity, quality of life, and healthcare use.

Conditions

Asthma

Keywords

Healthy Homes; Asthma; Community Health Worker

Outcome Measures

Primary Outcomes (3)

• Number of Emergency Department Visits

  Number of visits to an emergency department in prior 12 months

  12 months

• Daytime asthma symptom frequency

  Average frequency of daytime asthma symptoms over the past 12 months

  12 months

• Asthma-related quality of life score

  Score on asthma-related quality of life questionnaire

  12 months

Secondary Outcomes (3)

• Asthma Control Test score

  12 months

• Activity-limited days

  12 months

• Access to medical care

  12 months

Study Arms (2)

Maintenance Phase Intervention

EXPERIMENTAL

Participants receive a phone-based Community Health Worker (CHW) intervention in addition to bi-monthly data collection calls with a research assistant.

Behavioral: Maintenance Phase Intervention

Maintenance Phase Control

NO INTERVENTION

Participants receive no further interventions, but have bi-monthly data collection calls with a research assistant.

Interventions

Maintenance Phase Intervention BEHAVIORAL

The CHW will utilize motivational interviewing techniques over phone calls to reinforce all asthma education provided in the AI phase, including asthma basics, triggers and reduction strategies, purpose of medications, and steps for proper medication use. The CHW will identify barriers the participant is facing in management of their asthma and set goals to overcome them. The CHW will encourage regular visits with the Primary Care Physician and assist with referrals for other medical and social services, as needed. CHWs will check-in with participants via phone, monthly for the first 6 months and bi-monthly in the remaining 6 months Participants will receive bi-monthly data collection follow-up phone calls by a Research Assistant.

Maintenance Phase Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Resident of targeted Southwest or Westside communities of Chicago
• Diagnosed with asthma by a health care provider
• Has poorly controlled asthma, meeting one of the following criteria: Hospitalized for asthma within 12 months preceding enrollment; Visited an ED for asthma within 12 months preceding enrollment; Symptoms of persistent asthma - has been prescribed an inhaled corticosteroid in the last year, has asthma symptoms \> 2 days/week over past 2 months, has nighttime symptoms 3-4 times/month or more, or Short acting beta2-agonist use for symptom control \>2 days/week; or Has poorly controlled asthma per the Asthma Control Test (i.e., ACT score \< 19)
• Has completed the HCWABT Active Intervention

You may not qualify if:

• Participated in another comprehensive asthma program within the past year
• Plans to move out of Chicago within the study period
• Has a diagnosis of Chronic Heart Failure

Sponsors & Collaborators

• Sinai Health System: lead

Study Sites (1)

Mount Sinai Hospital

Chicago, Illinois, 60608, United States

Location

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

• Helen Margellos-Anast, MPH

  Sinai Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 5, 2018
• Study Start: November 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 5, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)