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| Name | Class |
|---|---|
| Innovative Medicines Initiative | OTHER |
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This study will test two instruments to measure physical activity in COPD patients: A questionnaire and two small physical activity monitors .Patients will be randomized to either receive the telecoaching program in addition to usual care or only the usual care. Study will include around 510 patients in 5 countries in Europe.
Chronic Obstructive Pulmonary Disease (COPD) has a negative influence on physical activity hence it may be beneficial for patients to increase physical activity levels. This study will test two instruments to measure physical activity: A questionnaire (completed on a personal digital assistant) and a physical activity monitor which patient wear during the day. Patients will be randomized to either receive the Telecoaching program in addition to usual care or only the usual care. The study will involve 4 clinic visits as well as some phone calls over duration of 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telecoaching | Experimental | Participants will receive daily coaching by an automated telehealth system and coaching by the investigator during study visits, in addition to the usual care. |
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| Control | Other | Participants will receive the usual care but will NOT receive daily coaching by telehealth system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated telehealth system | Device | The automated telehealth system (used within its intended use) comprises of CE marked medical devices and a CE marked step counter (Fitbug®), all being used within their intended use. Coaching by investigators is performed during the study visits and is aimed to enhance physical activity in patients across a spectrum of COPD severity, in addition to the usual care. |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of telecoaching program on the physical activity | Impact of telecoaching program on the physical activity of COPD patients will be measured via the use of two PROactive monitors (ActiGraph® and DynaPort®) and a PDA to complete the PROactive questionnaire. | 6 months |
| The construct validity of the PROactive instrument. | Construct validity of the PROactive instrument will be measured via the use of two PROactive monitors (ActiGraph® and DynaPort®) and a PDA to complete the PROactive questionnaire. | 6 months |
| The responsiveness of the PROactive instrument. | Responsiveness of the PROactive instrument will be measured via the use of two PROactive monitors (ActiGraph® and DynaPort®) and a PDA to complete the PROactive questionnaire. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Patients fulfilling any of the following criteria are not eligible for inclusion in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Innovative Medicines Initiative | PROactive is part of the European Innovative Medicines Initiative (IMI) | Principal Investigator |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Usual care | Other | Participants will receive usual care associated with Chronic Obstructive Pulmonary Disease (COPD) |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |