Clinical Effort Against Smoke Exposure in Cystic Fibrosis

NCT04777344 | Completed DMC

• 1 other identifier: IRB-300006654
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The study will test the feasibility, acceptability, and preliminary efficacy of a multi-component smoking cessation intervention tailored to the needs of caregivers of children with CF and delivered in clinical settings as part of routine CF care. The ultimate goal of this effort is to reduce the exposure of children and adolescents with CF to tobacco smoke.

Conditions

Cystic Fibrosis

Keywords

caregivers; tobacco; smoke exposure

Outcome Measures

Primary Outcomes (2)

• Intervention feasibility

  Participant drop-out rates and time added to the clinical encounter

  6 months

• Intervention acceptability

  Proportion of caregivers who accepted participation; Participant and provider satisfaction with the intervention on a 1-5 Likert scale; Perceived effectiveness of the intervention on a 1-5 Likert scale

  6 months

Secondary Outcomes (2)

• Self-reported caregiver cessation

  6 months

• Child smoke exposure

  6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive the multi-component intervention (counseling with intake assessment, follow-up, help obtaining nicotine replacement therapy, and CF-specific smoke exposure education)

Behavioral: Tobacco Treatment Specialist (TTS) intervention

Control group

NO INTERVENTION

The control group will receive usual care plus CF-specific smoke exposure education.

Interventions

Tobacco Treatment Specialist (TTS) intervention BEHAVIORAL

A trained Tobacco Treatment specialist (TTS) embedded in the multi-disciplinary CF care team will provide tobacco use counseling to smoking caregivers of children with CF.

Intervention group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult familial caregiver of a child with CF aged \<18 years
• Speak English
• Report smoking at least 1 cigarette in the previous week
• Not enrolled in a smoking cessation program

You may not qualify if:

• Do not report smoking at least 1 cigarette in the previous week
• Currently enrolled in a smoking cessation program.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Methods

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: single-center, randomized, open-label study

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 2, 2021
• Study Start: July 8, 2021
• Primary Completion: September 27, 2022
• Study Completion: September 27, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)