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| Name | Class |
|---|---|
| ITEC Services | OTHER |
| Lincoln Medical and Mental Health Center | OTHER |
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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.
Primary objective: To evaluate a strategy of Chronic Obstructive Pulmonary Disease (COPD) management to reduce the number of hospital days in patients with severe Gold III/IV COPD: a Home-Based COPD Management Program versus usual patient education and follow-up.
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disease management program | Experimental |
| |
| Usual site management | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disease Management | Other |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of unscheduled hospital days | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hospital days due to severe COPD exacerbation | up to 12 months | |
| Safety parameters | Adverse Events (AEs) | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Romain KESSLER, MD | Hopital Civil de Strasbourg - France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d Antibes Juans-les-pins | Antibes | 06606 | France | |||
| Hôpitaux Civils de Colmar - Hôpital Pasteur |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34495549 | Derived | 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. | |
| 29326333 | Derived | 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. |
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| Usual site management | Other |
|
|
| Medico-economic data |
Cost estimation, Cost-effectiveness, Cost-utility. |
| up to 12 months |
| Health related quality of life | up to 12 months |
| Use of health care services | up to 12 months |
| Compliance to oxygen therapy | up to 12 months |
| Colmar |
| 68024 |
| France |
| CHU de Grenoble | Grenoble | 38043 | France |
| Centre Hospitalier du Mans | Le Mans | 72037 | France |
| Hôpital de la Croix Rousse | Lyon | 69317 | France |
| Assistance Publique Hôpitaux de Marseille - Hôpital Nord | Marseille | 13015 | France |
| Hôpital MERCY | Metz | 57085 | France |
| Hôpital Saint Louis | Paris | 75010 | France |
| Groupe Hospitalier Pitié-Salpétrière | Paris | 75013 | France |
| Groupe Hospitalier Saint Joseph | Paris | 75674 | France |
| Hôpital Civil de Strasbourg | Strasbourg | 67098 | France |
| Hôpital Beauregard - CHR METZ | Thionville | 57100 | France |
| Hôpital Sainte Musse | Toulon | 83100 | France |
| Marien Krankenhaus | Kassel | Hesse | 34001 | Germany |
| Universitatklinikum | Aachen | 52074 | Germany |
| Helios Hagen-Ambrock | Hagen | 58091 | Germany |
| Thoraxklinik Heidelberg gGmbh | Heidelberg | 69126 | Germany |
| Lungenklinik Hemer | Hemer | 58675 | Germany |
| Fachkrankenhaus Kloster Grafschaft | Schmallenberg | 57392 | Germany |
| Klinik für Pneumologie und Allergologie | Solingen | 42699 | Germany |
| Universitätsklinikum Ulm, - Klinik Innere Medizin II | Ulm | 89081 | Germany |
| Azienda ULSS 22 - Ospedale di Bussolengo | Bussolengo | 37012 | Italy |
| ASL Viterbo | Civita Castellana | 01033 | Italy |
| Azienda Ospedaliera, "Ospedale San Carlo Borromeo" | Milan | 20153 | Italy |
| "Azienda Ospedaliera Niguarda | Milan | 20162 | Italy |
| Ospedale di Macerata | Province of Macerata | Italy |
| Azienda ospedialiera Di DESIO Vimercate | Seregno | 20831 | Italy |
| Hospital La Princessa | Madrid | Madrid | 28006 | Spain |
| Hospital Gregorio Maranon | Madrid | Madrid | 28007 | Spain |
| Hospital Ramon Y Cajal | Madrid | Madrid | 28034 | Spain |
| Hospital Universitario de Burgos | Burgos | 09006 | Spain |
| Hospital San Pedro de Alcantara | Cáceres | 10001 | Spain |
| Hospital Universitario de Asturia | Oviedo | 33006 | Spain |
| Hospital Arnau de Vilanova | Valencia | 46015 | Spain |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019468 | Disease Management |
| ID | Term |
|---|---|
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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