A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Comprehensive care programme
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Comprehensive care
Eligibility 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
Sites / Locations
- The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
comprehensive care programme
Control group
Arm Description
Comprehensive care involving multidisciplinary input.
Control arm with usual care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quality of Life
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
From contacting the patient/their family and hospital record retrieval.
Lung Function
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
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.
Full Information
NCT ID
NCT01108835
First Posted
April 16, 2010
Last Updated
July 21, 2017
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01108835
Brief Title
A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
Official Title
A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Comprehensive care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
comprehensive care programme
Arm Type
Active Comparator
Arm Description
Comprehensive care involving multidisciplinary input.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control arm with usual care
Intervention Type
Other
Intervention Name(s)
Comprehensive care programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Readmission
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of Life
Description
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.
Time Frame
12 months
Title
Mortality
Description
From contacting the patient/their family and hospital record retrieval.
Time Frame
12 months
Title
Lung Function
Description
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.
Time Frame
12 months
Title
Exercise Capacity
Description
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.
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Hui, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Study Director
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27471050
Citation
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.
Results Reference
derived
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A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
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