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

Impact of Support Groups for Patients With Non-Cystic Fibrosis Bronchiectasis on Quality of Life and Exacerbations

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.

Study Overview

• Status: Completed
• Conditions: Non-cystic Fibrosis Bronchiectasis
• Intervention / Treatment: Behavioral: Support Group

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: Support Group; monthly virtual patient support with multidisciplinary education for 12 sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation	Attendance to sessions will be tracked, with acceptable marked at 66% of sessions attended through the study period.	12-months
Rate of post-group survey	Participants will be tracked for completion of post-support group questionnaires sent at end of every meeting to assess relevance of the session, with acceptable as at least 66% of completion of surveys through the study period.	12-months
Exacerbation Rate	An exacerbation will be defined as a deterioration in three or more of the following for at least 48 hours: cough, sputum volume and/or consistency, sputum purulence, breathlessness and/or exercise tolerance, fatigue and/or malaise, hemoptysis, and a clinician determines that a change in bronchiectasis treatment is required. Assessment will include mean exacerbation per year for the prior two years, study duration, and subsequent one year.	12-months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Shoshana Zha, MD/PhD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): April 2, 2025
• Study Completion (Actual): April 2, 2025

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Patient Education; Support Group
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Bronchial Diseases; Fibrosis; Bronchiectasis
• Other Study ID Numbers: 23-40128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No