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

NCT ID: NCT06164470

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-04-02

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.

Detailed Description

Non-cystic fibrosis bronchiectasis (NCFBE) is a chronic disease of the airways characterized by progressive damage to the airways that impairs the ability to clear mucus leading to repeated cycles of inflammation and infection. The condition is associated with chronic cough, sputum production, and exacerbations requiring antibiotics and/or hospitalizations, and as such can have a significant effect on quality of life. Incidence and prevalence have been increasing in the past twenty years, with a concurrent worsening in socioeconomic burden. Chronic cough and sputum production, use of devices for airway clearance, decreased exercise tolerance, and frequent exacerbations can all lead to embarrassment and isolation. Per the European Respiratory Society (ERS) guidelines, impairment in quality of life in patients with bronchiectasis is "equivalent in terms of scores on the St George's Respiratory Questionnaire (SGRQ) to severe chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis and other disabling respiratory diseases." Patient support groups are well established for those living with these other chronic pulmonary diseases, but their efficacy is not well defined for NCFBE. This is a single center prospective interventional non-randomized pre-post study to evaluate the impact of a virtual patient support group and multidisciplinary educational program for patients with NCFBE using a mixed-methods approach seeking to compare how support groups affect quality of life, anxiety, and exacerbation rates for patients living with NCFBE. Participants will complete a series of questionnaires and will undergo assessment for severity of disease, comorbidities, and exacerbations before and after attending the group.

Conditions

Non-cystic Fibrosis Bronchiectasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Support Group

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

Group Type: OTHER

Support Group

Intervention Type: BEHAVIORAL

monthly virtual patient support with multidisciplinary education for 12 sessions

Interventions

Support Group

monthly virtual patient support with multidisciplinary education for 12 sessions

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

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

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shoshana Zha, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29788946 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29450201 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27821164 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34708118 (View on PubMed)

Other Identifiers

23-40128

Identifier Type: -

Identifier Source: org_study_id