A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT01108835

Last Updated: 2017-08-23

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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comprehensive care programme

Comprehensive care involving multidisciplinary input.

Group Type ACTIVE_COMPARATOR

Comprehensive care programme

Intervention Type OTHER

Intervention group:

* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
* Respiratory physician assessment and optimization of treatment
* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.

Control group

Control arm with usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Comprehensive care programme

Intervention group:

* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
* Respiratory physician assessment and optimization of treatment
* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Fanny W.S. Ko

Honorary Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David S Hui, MD

Role: STUDY_DIRECTOR

Chinese University of Hong Kong

Locations

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The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type DERIVED
PMID: 27471050 (View on PubMed)

Other Identifiers

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Resp/Ko/2010/001

Identifier Type: -

Identifier Source: org_study_id

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