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Completed

NCT Number: NCT00982384

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

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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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bat-Yam COPD Center, Bat Yam, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 40 years or older
  • Advanced COPD

Exclusion criteria

  • Permanent tracheostomy
  • Heart failure with significant left-ventricular dysfunction
  • Severe other chronic disease
  • Significant cognitive impairment, Drug or alcohol abuse, inability to cooperate
  • No telephone or permanent address
  • Bedridden
  • Refusal to use telemonitoring equipment
  • Participation in another clinical trial

Treatment and study plan

Disease management

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

Other

Comprehensive care for COPD patients recommended in clinical guidelines

Primary outcomes

  1. Hospital admission for acute exacerbation of COPD or all-cause mortality

    Time frame: Within 2 to 5 years after randomization

Secondary outcomes

  1. Total days of hospitalization for acute exacerbations of COPD

    Time frame: Within 2 to 5 years after randomization

  2. Quality of life

    Time frame: Within 2 to 5 years after randomization

  3. Total number of acute exacerbations of COPD

    Time frame: Within 2 to 5 years after randomization

  4. Depression

    Time frame: Within 2 to 5 years after randomization

  5. Functional capacity

    Time frame: Within 2 to 5 years after randomization

  6. Spirometry parameters

    Time frame: Within 2 to 5 years after randomization

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • Clalit Health Services

Registry information

Official study title

Comprehensive Disease Management Program in COPD Patients in the Community: Randomized Controlled Trial

Acronym: COPD_CDM

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 23, 2009
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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