NCT01241526

Brief Summary

The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD. By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
346

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2010

Longer than P75 for phase_4

Geographic Reach
4 countries

34 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

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

4.4 years

First QC Date

November 9, 2010

Last Update Submit

January 13, 2016

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPDCOMETDisease management

Outcome Measures

Primary Outcomes (1)

  • Number of unscheduled hospital days

    up to 12 months

Secondary Outcomes (6)

  • Number of hospital days due to severe COPD exacerbation

    up to 12 months

  • Safety parameters

    up to 12 months

  • Medico-economic data

    up to 12 months

  • Health related quality of life

    up to 12 months

  • Use of health care services

    up to 12 months

  • +1 more secondary outcomes

Study Arms (2)

Disease management program

EXPERIMENTAL
Other: Disease Management

Usual site management

ACTIVE COMPARATOR
Other: Usual site management

Interventions

Disease ManagementOTHER

* Individual, group and phone education sessions * Telephone supporter follow-up * LTOT monitoring

Also known as: Living Well With COPD Disease Management Program
Disease management program
Usual site managementOTHER

* Usual education as per site protocol * Usual follow-up as per site protocol * LTOT monitoring

Usual site management

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed Gold III/IV COPD
  • Current or ex-smoker with a smoking history ≥ 10 pack-years
  • At least one COPD exacerbation leading to hospitalization in the year before selection.

You may not qualify if:

  • LTOT for another reason than COPD
  • Severe concomitant disorder associated with a limited probability of survival (\< 6 months)
  • Tracheostomy
  • Long term oral corticosteroids therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Centre Hospitalier d Antibes Juans-les-pins

Antibes, 06606, France

Location

Hôpitaux Civils de Colmar - Hôpital Pasteur

Colmar, 68024, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Centre Hospitalier du Mans

Le Mans, 72037, France

Location

Hôpital de la Croix Rousse

Lyon, 69317, France

Location

Assistance Publique Hôpitaux de Marseille - Hôpital Nord

Marseille, 13015, France

Location

Hôpital MERCY

Metz, 57085, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

Groupe Hospitalier Pitié-Salpétrière

Paris, 75013, France

Location

Groupe Hospitalier Saint Joseph

Paris, 75674, France

Location

Hôpital Civil de Strasbourg

Strasbourg, 67098, France

Location

Hôpital Beauregard - CHR METZ

Thionville, 57100, France

Location

Hôpital Sainte Musse

Toulon, 83100, France

Location

Marien Krankenhaus

Kassel, Hesse, 34001, Germany

Location

Universitatklinikum

Aachen, 52074, Germany

Location

Helios Hagen-Ambrock

Hagen, 58091, Germany

Location

Thoraxklinik Heidelberg gGmbh

Heidelberg, 69126, Germany

Location

Lungenklinik Hemer

Hemer, 58675, Germany

Location

Fachkrankenhaus Kloster Grafschaft

Schmallenberg, 57392, Germany

Location

Klinik für Pneumologie und Allergologie

Solingen, 42699, Germany

Location

Universitätsklinikum Ulm, - Klinik Innere Medizin II

Ulm, 89081, Germany

Location

Azienda ULSS 22 - Ospedale di Bussolengo

Bussolengo, 37012, Italy

Location

ASL Viterbo

Civita Castellana, 01033, Italy

Location

Ospedale di Macerata

Macerata, Italy

Location

Azienda Ospedaliera, "Ospedale San Carlo Borromeo"

Milan, 20153, Italy

Location

"Azienda Ospedaliera Niguarda

Milan, 20162, Italy

Location

Azienda ospedialiera Di DESIO Vimercate

Seregno, 20831, Italy

Location

Hospital La Princessa

Madrid, Madrid, 28006, Spain

Location

Hospital Gregorio Maranon

Madrid, Madrid, 28007, Spain

Location

Hospital Ramon Y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Hospital San Pedro de Alcantara

Cáceres, 10001, Spain

Location

Hospital Universitario de Asturia

Oviedo, 33006, Spain

Location

Hospital Arnau de Vilanova

Valencia, 46015, Spain

Location

Related Publications (2)

  • Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.

    PMID: 34495549DERIVED

  • Kessler R, Casan-Clara P, Koehler D, Tognella S, Viejo JL, Dal Negro RW, Diaz-Lobato S, Reissig K, Rodriguez Gonzalez-Moro JM, Devouassoux G, Chavaillon JM, Botrus P, Arnal JM, Ancochea J, Bergeron-Lafaurie A, De Abajo C, Randerath WJ, Bastian A, Cornelissen CG, Nilius G, Texereau JB, Bourbeau J. COMET: a multicomponent home-based disease-management programme versus routine care in severe COPD. Eur Respir J. 2018 Jan 11;51(1):1701612. doi: 10.1183/13993003.01612-2017. Print 2018 Jan.

    PMID: 29326333DERIVED

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

  • Romain KESSLER, MD

    Hopital Civil de Strasbourg - France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2010

First Posted

November 16, 2010

Study Start

September 1, 2010

Primary Completion

February 1, 2015

Study Completion

October 1, 2015

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

IT(6)ES(7)FR(13)DE(8)