A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Comprehensive care programme

• Registration Number: NCT01108835
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2016-07-21
• Results First Submitted QC: 2017-02-12
• Results First Posted: 2017-03-30
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-21
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

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Exclusion Criteria

• Patients with asthma
• Patients unable to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
comprehensive care programme	Comprehensive care programme	Comprehensive care involving multidisciplinary input.

Primary Outcome Measures

Name	Time	Method
Hospital Readmission	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life	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	12 months	From contacting the patient/their family and hospital record retrieval.
Exercise Capacity	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.
Lung Function	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.

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong