A Phase 4 interventional study of Automated telehealth system and Usual care in COPD, sponsored by Novartis Pharmaceuticals. Withdrawn. Per ClinicalTrials.gov, last updated 2017-04-20.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Supportive care
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.
Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients fulfilling any of the following criteria are not eligible for inclusion in this study.
Participants will receive daily coaching by an automated telehealth system and coaching by the investigator during study visits, in addition to the usual care.
Device: Automated telehealth system · Other: Usual care
Participants will receive the usual care but will NOT receive daily coaching by telehealth system.
Other: Usual care
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.
Also known as: telehealth system
Participants will receive usual care associated with Chronic Obstructive Pulmonary Disease (COPD)
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
No study locations are listed for this record.
This study is withdrawn, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals