Objectif
Physical activity (PA) is essential in maintaining optimal health in chronic diseases, including COPD.More physically active patients have less hospital admissions and better survival. Validated physicalactivity monitors have become available in recent years, and together with patient report of symptomsand distress of physical (in)activity, this may form a potent new Patient Reported Outcome (PRO) in COPD.In response to the IMI-call this consortium will develop and validate two PRO’s. In phase 1, items for
the PRO will be generated based on input from an updated literature survey, expert opinion and patients. One PRO investigates PA on a daily basis, using a user friendly interface. This allows investigating the impact of exacerbations and the dynamics of improvement after initiating treatment. A second PRO is used during clinical trial visits. A unique feature of the PRO’s is that they will include unobtrusive physical activity monitoring. Validity, reproducibility, responsiveness and minimally
clinically meaningful difference of the PRO’s will be investigated. The new PRO’s will be put in thecontext of other, more conventional outcomes. using path-analysis and structural equational modeling.Development will be in compliance to the guidelines of the FDA and in collaboration with EMEA.Iii phase 2 the PRO’s will be used in 3 large multi-center clinical trials. These trials will contribute tothe validity and health economic value of the PRO’s. They tackle contemporary questions in COPDcare, including pharmacotherapy, PA counseling and pulmonary rehabilitation.The consortium is well equipped to develop PRO’s. It includes academic centers with a solid reputationin COPD research, centers with expertise in epidemiology, experts in conducting systematic reviews,PRO-methodology and statistics. Patient associations are in the core of the consortium. A SME willdevelop patient material in various languages.
Champ scientifique
Appel à propositions
IMI-JU-01-2008
Voir d’autres projets de cet appel
Régime de financement
JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)Coordinateur
43122 Parma
Italie
Voir sur la carte
Participants (19)
3000 Leuven
Voir sur la carte
TW89GS Brentford
Voir sur la carte
EH8 9YL Edinburgh
Voir sur la carte
106 75 KOLONAKI, ATHENS GREECE
Voir sur la carte
SW3 6NP LONDON
Voir sur la carte
Participation terminée
08003 Barcelona
Voir sur la carte
8006 Zurich
Voir sur la carte
9713 GZ Groningen
Voir sur la carte
3831PE Leusden
Voir sur la carte
EC1V 7ER London
Voir sur la carte
SG4 0TY Hitchin, Hertfordshire
Voir sur la carte
1003 Lausanne
Voir sur la carte
Participation terminée
CT13 9NJ Sandwich
Voir sur la carte
08022 Barcelona
Voir sur la carte
4056 Basel
Voir sur la carte
151 85 Sodertaelje
Voir sur la carte
1070 Bruxelles / Brussel
Voir sur la carte
55218 Ingelheim
Voir sur la carte
08003 BARCELONA
Voir sur la carte