NCT01644916

Brief Summary

Chronic obstructive pulmonary disease (COPD) stands out among chronic diseases with its high and rising prevalence and mortality, poor quality of life, high re-hospitalization rates and societal burden of care. Current therapeutic and management practices are generally met with limited success. Research in recent years have highlighted the high level of psychiatric co-morbidity in COPD patients, and the major prognostic significance of anxiety/depression in COPD outcomes such as re-hospitalization, smoking cessation, quality of life, and survival. This suggests that addressing psychiatric and psycho-social aspects of care prominent in COPD patients may have strongly positive impact on outcomes, but the available evidence of effectiveness is limited. The primary aim of the proposed research is to evaluate the effectiveness of a holistic disease management paradigm of psychiatric liaison consultation (CL) that integrates psychiatric and respiratory care to improve outcomes for COPD patients. This integrated psychiatric consultation liaison (IPCL) management paradigm includes the routine screening and structured collaborative care of anxiety and major depressive symptoms and depressive/anxiety disorder in COPD patients. We postulate that the IPCL care paradigm would reduce mood symptoms, increase smoking quit rates, reduce symptom burden and functional disability, and improve quality of life, while reducing rehospitalization, emergency department (ED) and unscheduled physician visits. A secondary aim is to evaluate its cost effectiveness by concurrently collecting resource utilization data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
295

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

5.3 years

First QC Date

July 17, 2012

Last Update Submit

September 5, 2018

Conditions

Keywords

COPDIntegrated careIPCL

Outcome Measures

Primary Outcomes (1)

  • HADS score

    Anxiety and depression symptoms and diagnosis

    over 12 months

Secondary Outcomes (1)

  • Resource use and direct costs of care

    over 12 months

Study Arms (2)

Usual control

OTHER

Usual control will be provided with usual standard management of COPD and psychiatric comorbidities.

Procedure: Usual control

Integrated care

OTHER

Integrated care will be provided with integrated care management.

Procedure: Integrated care

Interventions

Integrated care will be provided with management of multifaceted group including, nurse educators, doctors, case manager and psychologists.

Also known as: IPCL
Integrated care
Usual controlPROCEDURE

Usual control group will be provided with usual standard procedures for management of COPD and psychiatric comorbidities.

Usual control

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatients and specialist outpatients from: NUHS, SGH, CGH, SLH and AH.
  • Clinical diagnosis of chronic obstructive pulmonary disease (COPD) based on history, physical examination, spirometry, measurement of arterial blood gases, and chest radiographs, that meets the criteria for COPD as defined in the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
  • COPD patients include cases of all grades of severity, and co-morbidity, without restriction.
  • Participants provide written informed consent.

You may not qualify if:

  • Known diagnosis of a psychiatric disorder that is under treatment.
  • Terminally ill COPD patients who are unable to complete baseline assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital System

Singapore, 119228, Singapore

Location

Related Publications (5)

  • Ng TP, Niti M, Tan WC. Trends and ethnic differences in COPD hospitalization and mortality in Singapore. COPD. 2004 Apr;1(1):5-11. doi: 10.1081/COPD-120028702.

    PMID: 16997734BACKGROUND
  • Niti M, Ng TP, Kua EH, Ho RC, Tan CH. Depression and chronic medical illnesses in Asian older adults: the role of subjective health and functional status. Int J Geriatr Psychiatry. 2007 Nov;22(11):1087-94. doi: 10.1002/gps.1789.

    PMID: 17407107BACKGROUND
  • Ng TP, Niti M, Fones C, Yap KB, Tan WC. Co-morbid association of depression and COPD: a population-based study. Respir Med. 2009 Jun;103(6):895-901. doi: 10.1016/j.rmed.2008.12.010. Epub 2009 Jan 10.

    PMID: 19136238BACKGROUND
  • Cao Z, Ong KC, Eng P, Tan WC, Ng TP. Frequent hospital readmissions for acute exacerbation of COPD and their associated factors. Respirology. 2006 Mar;11(2):188-95. doi: 10.1111/j.1440-1843.2006.00819.x.

    PMID: 16548905BACKGROUND
  • Ng TP, Niti M, Tan WC, Cao Z, Ong KC, Eng P. Depressive symptoms and chronic obstructive pulmonary disease: effect on mortality, hospital readmission, symptom burden, functional status, and quality of life. Arch Intern Med. 2007 Jan 8;167(1):60-7. doi: 10.1001/archinte.167.1.60.

    PMID: 17210879BACKGROUND

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAnxiety DisordersDepression

Interventions

Delivery of Health Care, Integrated

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Ng T Pin, MD

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 19, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations