NCT01688180

Brief Summary

Patients with chronic diseases are at great risk of depression and anxiety.It is known that depression and anxiety are one of the most common comorbidities associated with chronic lung diseases such as asthma and chronic obstructive pulmonary disease. However,to date,little is known about the rates and risk factors of depression and anxiety symptoms in non-CF bronchiectasis;and no large-scale prospective studies have been performed to investigate the effect of depression and anxiety on the healthy outcomes(such as number of exacerbations and hospitalizations over the ensuing year).Our purpose is to fill these gaps.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

1.4 years

First QC Date

September 14, 2012

Last Update Submit

August 6, 2013

Conditions

Keywords

bronchiectasisdepressionanxiety

Outcome Measures

Primary Outcomes (1)

  • To evaluate the impact of depression and anxiety symptoms on non-CF bronchiectasis health outcomes.

    Depression and anxiety are assessed at baseline using the Hospital Anxiety and Depression Scale(HADS).Health-related quality of life(HRQL) is measured using St.George's Respiratory Questionnaire(SGRQ), Leicester cough questionnaire(LCQ) and COPD assessment test(CAT) at baseline and follow-up.In the ensuing year,patients are monitored monthly by telephnone for 12 months to document the occurrence and characteristics of non-CF bronchiectasis exacerbations and hospitalizations.Patients are also encouraged to report to their investigators and research nurses whenever they experience symptom worsening.An exacerbation was defined as persistent (\>24 hour) deterioration in at least three respiratory symptoms (including cough,dyspnoea, haemoptysis, increased sputum purulence or volume, and chest pain), with or without fever (\>37.5˚ C),radiographic deterioration, systemic disturbances, or deterioration in chest signs.

    one year

Secondary Outcomes (1)

  • To estimate the prevalence of anxiety and depression symptoms in patients with non-CF bronchiectasis

    six months

Other Outcomes (1)

  • To identify risk factors associated with symptoms of depression and anxiety in patients with non-CF bronchiectasis

    six months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with non-CF bronchiectasis attending the First Affiliated Hospital of Guangzhou Medical College,Guangzhou,Guangdong,China

You may qualify if:

  • Age ≥18 years
  • HRCT diagnosed Bronchiectasis
  • No fever,no worsening of respiratory symptoms,and no medication change within the 4 weeks before recruitment.
  • Capable of providing written informed consent

You may not qualify if:

  • cystic fibrosis
  • Previous lung transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

  • Gao YH, Guan WJ, Xu G, Gao Y, Lin ZY, Tang Y, Lin ZM, Li HM, Luo Q, Zhong NS, Birring SS, Chen RC. Validation of the Mandarin Chinese version of the Leicester Cough Questionnaire in bronchiectasis. Int J Tuberc Lung Dis. 2014 Dec;18(12):1431-7. doi: 10.5588/ijtld.14.0195.

MeSH Terms

Conditions

BronchiectasisDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Yongchang Chen, professor

    The First Affiliated Hospital of Guangzhou Medical University

    STUDY DIRECTOR
  • Nanshan Zhong, Professor

    The First Affiliated Hospital of Guangzhou Medical University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

September 14, 2012

First Posted

September 19, 2012

Study Start

December 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations