A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
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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 |
- 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
| 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:
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 |
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| Contact: Fanny W Ko, MD | 852 26322785 | fannyko@cuhk.edu.hk |
| Hong Kong | |
| The Chinese University of Hong Kong | Recruiting |
| Hong Kong, Hong Kong | |
| Contact: Fanny W Ko, MD 852 26322785 fannyko@cuhk.edu.hk | |
| 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 May 22, 2013