A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
|ClinicalTrials.gov Identifier: NCT01108835|
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : March 30, 2017
Last Update Posted : August 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Other: Comprehensive care programme||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Active Comparator: comprehensive care programme
Comprehensive care involving multidisciplinary input.
Other: Comprehensive care programme
No Intervention: Control group
Control arm with usual care
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108835
|The Chinese University of Hong Kong|
|Hong Kong, Hong Kong|
|Study Director:||David S Hui, MD||Chinese University of Hong Kong|