Comprehensive Disease Management Program in Chronic Obstructive Pulmonary Disease (COPD) Patients in the Community

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to determine whether comprehensive disease management program combined with best care recommended in clinical guidelines, is more effective than best care alone in patients with advanced chronic obstructive pulmonary disease (COPD).

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Detailed Description

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The study objective is to evaluate the effectiveness of a comprehensive program among patients with advanced COPD, implemented by a multi-disciplinary team. The program consists of best care recommended in clinical guidelines, combined with disease management, compared to best care only.

The program will include designated COPD centers operated by multi-disciplinary teams (pulmonologists, nurse practitioners, physiotherapists, social workers and dietitians). Disease management will be provided in these centers by qualified designated nurses.

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Disease management

Comprehensive disease management in addition to best care according to clinical guidelines for COPD patients

Group Type EXPERIMENTAL

Disease management

Intervention Type OTHER

Disease management by COPD nurses, including active follow-up and coordination of care in addition to best care according to clinical guidelines for COPD patients

Best care

Best care according to clinical guidelines for COPD patients

Group Type ACTIVE_COMPARATOR

Best care

Intervention Type OTHER

Comprehensive care for COPD patients recommended in clinical guidelines

Interventions

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Disease management

Disease management by COPD nurses, including active follow-up and coordination of care in addition to best care according to clinical guidelines for COPD patients

Intervention Type OTHER

Best care

Comprehensive care for COPD patients recommended in clinical guidelines

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age 40 years or older
2. Advanced COPD

Exclusion Criteria

1. Permanent tracheostomy
2. Heart failure with significant left-ventricular dysfunction
3. Severe other chronic disease
4. Significant cognitive impairment, Drug or alcohol abuse, inability to cooperate
5. No telephone or permanent address
6. Bedridden
7. Refusal to use telemonitoring equipment
8. Participation in another clinical trial

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No