NCT05045690

BREATHE: An Efficacy-implementation With Listening Sessions

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Asthma

Timeline

• Start date: 2021-11-19
• Primary completion: 2022-06-09
• Completion: 2022-06-09
• First posted: 2021-09-16
• Last updated: 2023-01-10

Locations

1 site across 1 country: United States