A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01108835
First received: April 16, 2010
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Other: Comprehensive care programme

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Hospital readmission [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured by St. George Respiratory Questionnaire and Chronic Respiratory Questionnaire

  • Mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    From contacting the patient/their family and hospital record retrieval.

  • Lung function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measurement of spirometry

  • Exercise capacity [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    6 min walk test


Estimated Enrollment: 190
Study Start Date: April 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: comprehensive care
Comprehensive care
Other: Comprehensive care programme

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.
Other Name: Comprehensive care programme
No Intervention: Control group
Control arm with usual care

Detailed Description:

Design: A randomised controlled trial of patients discharged from hospital after an episode of acute exacerbation of COPD. Patients will be randomised to the intervention arm or usual care group.

Setting: Tertiary University affiliated Hospital.

Interventions:

The Intervention group will receive a comprehensive programme which involves inputs from doctors, respiratory nurses and physiotherapists, providing an individualized care plan for each subject. The components in the programme will include optimization of medications, specialist physician follow up, nursing support in education, and physiotherapist support for pulmonary rehabilitation. Patients in the intervention group will also receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and answer their queries. Patients will also be followed up in the respiratory clinic by respiratory specialist once every 3 months for 1 year.

The control group will be managed as the usual care. The discharging physician will determine the patients' medication and follow up as in normal practice.

All patients will be asked to return for assessments (spirometry, 6 minute walk test, questionnaires on the severity of dyspnoea and quality of life) at baseline and 12 months

Main outcome measures: The primary endpoint is the hospital readmission rate and the secondary endpoints are the quality of life, mortality, lung function and exercise capacity of the patients.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with asthma
  • Patients unable to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108835

Contacts
Contact: Fanny W Ko, MD 852 26322785 fannyko@cuhk.edu.hk

Locations
Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Fanny W Ko, MD    852 26322785    fannyko@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Study Director: David S Hui, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: The Chinese Univeristy of Hong Kong, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01108835     History of Changes
Other Study ID Numbers: Resp/Ko/2010/001
Study First Received: April 16, 2010
Last Updated: June 22, 2011
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Chinese University of Hong Kong:
COPD
Comprehensive care

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014