NCT00982384

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

4.7 years

First QC Date

September 14, 2009

Last Update Submit

May 19, 2015

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic obstructive pulmonary diseaseDisease managementPulmonary rehabilitationQuality of life

Outcome Measures

Primary Outcomes (1)

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

    Within 2 to 5 years after randomization

Secondary Outcomes (6)

  • Total days of hospitalization for acute exacerbations of COPD

    Within 2 to 5 years after randomization

  • Quality of life

    Within 2 to 5 years after randomization

  • Total number of acute exacerbations of COPD

    Within 2 to 5 years after randomization

  • Depression

    Within 2 to 5 years after randomization

  • Functional capacity

    Within 2 to 5 years after randomization

  • +1 more secondary outcomes

Study Arms (2)

Disease management

EXPERIMENTAL

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

Other: Disease management

Best care

ACTIVE COMPARATOR

Best care according to clinical guidelines for COPD patients

Other: Best care

Interventions

Disease managementOTHER

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

Disease management
Best careOTHER

Comprehensive care for COPD patients recommended in clinical guidelines

Best care

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 years or older
  • Advanced COPD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bat-Yam COPD Center

Bat Yam, Israel

Location

COPD Center, Hadera

Hadera, Israel

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Disease Management

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services Administration

Study Officials

  • Ofra Kalter - Leibovici, M.D.

    Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center

    PRINCIPAL INVESTIGATOR

  • Gershon Fink, M.D.

    Clalit Health Services

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Unit of Cardiovascular Epidemiology, Gertner Institute.

Study Record Dates

First Submitted

September 14, 2009

First Posted

September 23, 2009

Study Start

October 1, 2009

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

IL(2)