RightFit
RecruitingNot applicable

BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma

BREATHE: An Efficacy-implementation Trial of a Brief Shared Decision Making Intervention Among Black Adults With Uncontrolled Asthma in Federally Qualified Health Centers (Trial and Post-trial)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "We will conduct post-trial mixed-method interviews with patient participants, their loved ones, and PCPs using evaluation frameworks to determine satisfaction with, and acceptability of, the active and control interventions."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well BREATHE works for 200 Black adults whose asthma is not under control and who get care at partner community health centers in cities. It also looks at what helps or gets in the way of using BREATHE at these centers.

This study is an efficacy-implementation trial to: 1. evaluate systematically the efficacy of BREATHE in 200 Black adults receiving care at urban federally qualified health centers (FQHCs) for uncontrolled asthma; and 2. identify multi-level barriers and facilitators to the widespread adoption and implementation of BREATHE in FQHCs.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients: Be age 18 or older.
  • Patients: Identify as Black, including African American, African, Caribbean, West Indian, or Black and another race. You may be Hispanic or non-Hispanic.
  • Patients: Have ongoing asthma diagnosed by a clinician and have been prescribed an inhaled steroid medicine in the past 4 years; or have had an asthma flare-up, such as one needing an ER visit or prednisone, whether or not you use daily asthma medicine.
  • Patients: Get asthma care at a partner federally qualified health center, a type of community health center.
  • Patients: Have survey results showing asthma is not under control and some incorrect beliefs about asthma.
  • Clinicians: Manage care for a group of adults with asthma.
  • Loved ones: Be a family member or friend whom a patient in the study names as a loved one.

Who can't join

  • Patients and loved ones: Do not speak English.
  • Patients and loved ones: Have a serious mental health condition that prevents doing study tasks or makes study results hard to interpret.
  • Patients: Have taken part in a listening session.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria (participants): Patients participants will 1. be adults (\> or = 18 years of age) 2. self-report race as 'Black' race (African American, African, Caribbean, West Indian, multi-racial \[Black AND one or more additional races\]); identify their ethnicity as Hispanic OR non-Hispanic 3. have clinician-diagnosed persistent asthma (defined as being prescribed inhaled corticosteroids in the last 48 months) or have had an asthma exacerbation (e.g., ER visit, course of Prednisone) regardless of controller medicine use 4. receive asthma care at a partner FQHC and 5. screen positive for uncontrolled asthma as measured by the Asthma Control Questionnaire- 6 items (ACQ-6) and erroneous beliefs as measured by the Conventional and Alternative Management for Asthma (CAM-A) survey. Exclusion Criteria (participants): 1. non-English speaking 2. serious mental health conditions that preclude completion of study procedures or confound analyses or 3. participation in a listening session Inclusion Criterion (clinicians): 1\. those who manage a panel of adult asthma patients Inclusion Criteria (loved ones): 1. must be identified by patient participant as a loved one and 2. loved one must be a family member or friend of the patient participant. Exclusion Criteria (loved ones): 1. non-English speaking or 2. serious mental health conditions that preclude completion of study procedures or confound analyses

Study sites (2)

NY