A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
|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|
- 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.
- 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
|Study Start Date:||April 2010|
|Study Completion Date:||July 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: comprehensive care
Other: Comprehensive care programme
No Intervention: Control group
Control arm with usual care
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108835
|The Chinese University of Hong Kong|
|Hong Kong, Hong Kong|
|Study Director:||David S Hui, MD||Chinese University of Hong Kong|