Impact of Support Groups for Patients With Non-Cystic Fibrosis Bronchiectasis

NCT06164470 | Completed

• 1 other identifier: 23-40128
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

BronchConnect is a prospective trial to investigate the impact of support groups on health care related quality of life in those with noncystic fibrosis bronchiectasis (NCFBE). It has been well demonstrated that participation in patient support groups improves quality of life in those who suffer from interstitial lung disease and chronic obstructive pulmonary disease, but the impact is largely unknown for those who live with NCFBE, a chronic lung disease with rising prevalence with no targeted FDA-approved therapy. NCFBE causes chronic cough, dyspnea, recurrent infections, and leads to anxiety and uncertainty. This study seeks to evaluate the impact of a virtual patient support group for patients with NCFBE through questionnaires to assess change of quality of life and anxiety, and exacerbation rates through clinical assessment.

Conditions

Non-cystic Fibrosis Bronchiectasis

Keywords

Support Group; Patient Education

Outcome Measures

Primary Outcomes (2)

• Health-related quality of life

  The Quality of Life-Bronchiectasis (QOL-B) is a validated questionnaire that assesses bronchiectasis symptoms and their effect on quality of life. QOL-B V3.1 is 37 items in 8 scales that each are scored 0 to 100, including respiratory symptoms, functioning, health perception, vitality, and treatment burden. We will track change for each domain over time.

  Baseline, 3-months, 6-months, 12-months

• Anxiety

  The General Anxiety Disorder-7 is a commonly used questionnaire that assesses clinical anxiety using 7 questions over the past 14-day period. This will be tracked for score improvement (i.e. lower) over time.

  Baseline, 3-months, 6-months, 12-months

Secondary Outcomes (3)

• Exacerbation Rate

  12-months

• Participation

  12-months

• Rate of post-group survey

  12-months

Study Arms (1)

Support Group

OTHER

Non-randomized pre-post trial, in which each participant will serve as their own control. Participants will be recruited from a bronchiectasis specialty clinic.

Behavioral: Support Group

Interventions

Support Group BEHAVIORAL

monthly virtual patient support with multidisciplinary education for 12 sessions

Support Group

Eligibility Criteria

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

You may qualify if:

• Diagnosis of bronchiectasis on computed tomography (CT) chest scan
• Bronchiectasis is the primary respiratory disease as determined by a clinician

You may not qualify if:

• Age \< 18 years old
• Cystic fibrosis
• Traction bronchiectasis in the context of pulmonary fibrosis
• Solid organ transplant recipient
• Ability to provide informed consent
• Due to constraints of this pilot study, inability to engage in a full conversation in English

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (4)

• Hester KLM, Newton J, Rapley T, De Soyza A. Patient information, education and self-management in bronchiectasis: facilitating improvements to optimise health outcomes. BMC Pulm Med. 2018 May 22;18(1):80. doi: 10.1186/s12890-018-0633-5.

  PMID: 29788946 BACKGROUND

• Hashem F, Merritt R. Supporting patients self-managing respiratory health: a qualitative study on the impact of the Breathe Easy voluntary group network. ERJ Open Res. 2018 Feb 9;4(1):00076-2017. doi: 10.1183/23120541.00076-2017. eCollection 2018 Jan.

  PMID: 29450201 BACKGROUND

• Alcazar B, de Lucas P, Soriano JB, Fernandez-Nistal A, Fuster A, Gonzalez-Moro JM, Arnedillo A, Sidro PG, de Los Monteros MJ. The evaluation of a remote support program on quality of life and evolution of disease in COPD patients with frequent exacerbations. BMC Pulm Med. 2016 Nov 8;16(1):140. doi: 10.1186/s12890-016-0304-3.

  PMID: 27821164 BACKGROUND

• Athanazio RA. Bronchiectasis: moving from an orphan disease to an unpleasant socioeconomic burden. ERJ Open Res. 2021 Oct 25;7(4):00507-2021. doi: 10.1183/23120541.00507-2021. eCollection 2021 Oct.

  PMID: 34708118 BACKGROUND

MeSH Terms

Interventions

Self-Help Groups

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Shoshana Zha, MD/PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: April 1, 2024
• Primary Completion: April 2, 2025
• Study Completion: April 2, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)