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临床试验/NCT06164470
NCT06164470已完成不适用

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

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Health-related quality of life

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Support Group (Behavioral)

结局指标

主要结局

Health-related quality of life

时间窗: Baseline, 3-months, 6-months, 12-months

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.

Anxiety

时间窗: Baseline, 3-months, 6-months, 12-months

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.

次要结局

  • Exacerbation Rate(12-months)
  • Rate of post-group survey(12-months)
  • Participation(12-months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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