BREATHE: An Efficacy-implementation With Listening Sessions

Asthma Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05045690
• Other study ID #: AAAT0939 - pre-trial
• Secondary ID: 1R01NR019275
• Status: Completed
• Start date: November 19, 2021
• Est. completion date: June 9, 2022

Study information

• Verified date: January 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. be adults (> 18 years of age or emancipated)

2. 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

3. have clinician-diagnosed asthma

4. receive asthma care at a partner federally-qualified health center (FQHC)

Exclusion Criteria:

1. non-English speaking

2. serious mental health conditions that preclude completion of study procedures or confound analyses

3. 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.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	Clinical Directors Network	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Clinical Directors Network, National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who completed listening sessions	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.	Visit 1 (approximately 120 minutes)
Primary	Number of participants who completed clinician/administrator pre-trial interviews	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.	Visit 1 (approximately 30 minutes)