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Completed

NCT Number: NCT05045690

BREATHE: An Efficacy-implementation With Listening Sessions

Listening sessions: The research team will collect qualitative data from the listening sessions (focus groups) using a semi-structured iterative focus group guide.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Directors Network

New York, 10018, United States

About this study

The trial will be informed by 4-8 listening sessions (research focus groups) with 4-8 adults with asthma at each of four sites (N=32). The trial will also include interviews with approximately 1-2 providers and 1-2 administrators at each site (N=8-16).

Adults with asthma and providers/administrators will participate in pre-trial listening sessions (focus groups) prior to recruiting for other phases in this project. They will share their experience with asthma and clinical research. This will aid in gaining the identification of possible barriers to participation and will provide the opportunity for the patients and providers/administrators to identify which of the planned outcomes they consider to be most meaningful. After obtaining informed consent from participants, the research team will collect demographic and diagnosis information, administer surveys and conduct listening sessions.

The research team will collect demographic information and administer questionnaires to characterize the participants. These include: Demographic form, Asthma history (patient), Asthma history (family), Asthma Control Questionnaire, Shared Decision Making Questionnaire, Medication Adherence Record Scale (preventer), Conventional and Alternative Management for Asthma (patient), Conventional and Alternative Management for Asthma (family), Asthma Quality of Life Questionnaire, Newest Vital Sign, and Short Assessment of Health Literacy. Pre-trial listening sessions: one 2-hour session.

Providers/administrators will participate in one 30-minute session interview.

This pre-trial is an informative research that will help design an RCT with masking and allocation in the future.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • be adults (> 18 years of age or emancipated)
  • self-report '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
  • have clinician-diagnosed asthma
  • receive asthma care at a partner federally-qualified health center (FQHC)

Exclusion criteria

  • non-English speaking
  • serious mental health conditions that preclude completion of study procedures or confound analyses
  • participation in a listening session

Inclusion criteria

(provider/administrator): Providers who manage a panel of adult asthma patients (i.e., eligible for randomization in the trial) and administrators at that site will be recruited to participate in the interviews.

Treatment and study plan

Primary outcomes

  1. Number of participants who completed listening sessions

    Time frame: Visit 1 (approximately 120 minutes)

    Listening sessions (research focus groups) will be held pre-trial to explore experiences with asthma and clinical research. Sharing from these sessions will be observational in nature where information will be collected to aid the design/implementation of other portions in this project.

  2. Number of participants who completed clinician/administrator pre-trial interviews

    Time frame: Visit 1 (approximately 30 minutes)

    Interviews will be held pre-trial to explore experiences with asthma and clinical research. Sharing from these sessions will be observational in nature where information will be collected to aid the design/implementation of other portions in this project.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Clinical Directors Network
  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2021
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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