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A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01108835
First Posted: April 22, 2010
Last Update Posted: August 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fanny W.S. Ko, Chinese University of Hong Kong
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Fanny W.S. Ko, Chinese University of Hong Kong:

Primary Outcome Measures:
  • Hospital Readmission [ Time Frame: 12 months ]
    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 ]
    Measured by change in St. George Respiratory Questionnaire (SGRQ) total score from baseline to 12 month. SGRQ total score ranged from 0-100. The change was calculated by the 12 month SGRQ total score minus the baseline value. Negative values indicated improvement in quality of life.

  • Mortality [ Time Frame: 12 months ]
    From contacting the patient/their family and hospital record retrieval.

  • Lung Function [ Time Frame: 12 months ]
    Measurement of change of spirometry (FEV1 % predicted) from baseline to 12 month. The range is from 0% to 100%. The change was calculated by 12 month value minus the baseline value. Positive value indicated improvement in lung function.

  • Exercise Capacity [ Time Frame: 12 month ]
    Exercise capacity was measured by change in 6 minutes walk test distance from baseline to 12 month. 6 minute walk test is the distance that the patient can walk over 6 minutes and it can range to 0 meters to few hundred meters. This was calculated by the 12 month 6 minutes walk test distance minus that of the baseline. Positive values indicated improvement in exercise capacity.


Enrollment: 180
Study Start Date: April 2010
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: comprehensive care programme
Comprehensive care involving multidisciplinary input.
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.
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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108835


Locations
Hong Kong
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Study Director: David S Hui, MD Chinese University of Hong Kong
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fanny W.S. Ko, Honorary Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01108835     History of Changes
Other Study ID Numbers: Resp/Ko/2010/001
First Submitted: April 16, 2010
First Posted: April 22, 2010
Results First Submitted: July 21, 2016
Results First Posted: March 30, 2017
Last Update Posted: August 23, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fanny W.S. Ko, Chinese University of Hong Kong:
COPD
Comprehensive care

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