BREATHE: An Efficacy-implementation With Listening Sessions

NCT ID: NCT05045690

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-19
• Study Completion Date: 2022-06-09

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Directors Network

NETWORK

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Maureen George

Professor of Nursing at the Columbia University Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maureen T George, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Clinical Directors Network

New York, New York, United States

Countries

United States

Other Identifiers

1R01NR019275

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAT0939 - pre-trial

Identifier Type: -

Identifier Source: org_study_id