Clinical trial NCT01108835: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Comprehensive care
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-04-22
Enrollment: 180
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hospital Readmission
timeFrame: 12 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Lung Function
timeFrame: 12 months
measure: Exercise Capacity
timeFrame: 12 month
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: David S Hui, MD
role: STUDY_DIRECTOR
References:
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.