NCT01108835

Brief Summary

Objective: Chronic obstructive pulmonary disease (COPD) is a disease with significant morbidity and incurs heavy utilization of healthcare resources. The direct cost of hospital admissions related to COPD is the single largest source of expenditure in the public hospital system. This study aims to assess whether a comprehensive care programme can decrease the rate of hospital admissions for COPD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

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

Timeline
Completed

Started Apr 2010

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

Study Start

First participant enrolled

April 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 30, 2017

Completed
Last Updated

August 23, 2017

Status Verified

July 1, 2017

Enrollment Period

5.3 years

First QC Date

April 16, 2010

Results QC Date

July 21, 2016

Last Update Submit

July 21, 2017

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDComprehensive care

Outcome Measures

Primary Outcomes (1)

  • Hospital Readmission

    To investigate the effectiveness of a comprehensive care programme in reducing hospital admission in COPD patients who have been discharged from hospital for an episode of AECOPD.

    12 months

Secondary Outcomes (4)

  • Quality of Life

    12 months

  • Mortality

    12 months

  • Lung Function

    12 months

  • Exercise Capacity

    12 month

Study Arms (2)

comprehensive care programme

ACTIVE COMPARATOR

Comprehensive care involving multidisciplinary input.

Other: Comprehensive care programme

Control group

NO INTERVENTION

Control arm with usual care

Interventions

Comprehensive care programmeOTHER

Intervention group: * Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions * Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation) * Respiratory physician assessment and optimization of treatment * Patients will also be taught about a personalized action plan by the physician and respiratory nurse. * Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.

comprehensive care programme

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are admitted to the Prince of Wales Hospital with AECOPD will be screened for this study.
  • Patients with age over 40 years

You may not qualify if:

  • Patients with asthma
  • Patients unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Ko FW, Cheung NK, Rainer TH, Lum C, Wong I, Hui DS. Comprehensive care programme for patients with chronic obstructive pulmonary disease: a randomised controlled trial. Thorax. 2017 Feb;72(2):122-128. doi: 10.1136/thoraxjnl-2016-208396. Epub 2016 Jul 28.

    PMID: 27471050DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Fanny Ko
Organization
The Chinese University of Hong Kong
fannyko@cuhk.edu.hk
85226323133

Study Officials

  • David S Hui, MD

    Chinese University of Hong Kong

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Associate Professor

Study Record Dates

First Submitted

April 16, 2010

First Posted

April 22, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 23, 2017

Results First Posted

March 30, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)