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Study to Evaluate the Impact of the "PROactive Telecoaching Program" on Physical Activity in Patients With COPD. (PROactive)

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ClinicalTrials.gov Identifier: NCT01992081
Recruitment Status : Withdrawn
First Posted : November 25, 2013
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
Innovative Medicines Initiative
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COPD Device: Automated telehealth system Other: Usual care Phase 4

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A 6-month Multicenter Randomized Trial to Evaluate the Impact of the "PROactive Telecoaching Program" on Physical Activity in Patients With COPD
Study Start Date : May 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telecoaching
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
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.
Other Name: telehealth system

Other: Usual care
Participants will receive usual care associated with Chronic Obstructive Pulmonary Disease (COPD)

Control
Participants will receive the usual care but will NOT receive daily coaching by telehealth system.
Other: Usual care
Participants will receive usual care associated with Chronic Obstructive Pulmonary Disease (COPD)




Primary Outcome Measures :
  1. The impact of telecoaching program on the physical activity [ Time Frame: 6 months ]
    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.

  2. The construct validity of the PROactive instrument. [ Time Frame: 6 months ]
    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.

  3. The responsiveness of the PROactive instrument. [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Male and female patients ≥ 40 years of age
  • Diagnosis of COPD (GOLD criterion: post bronchodilator FEV1/FVC< 70%)
  • Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year)
  • Patients should have at least 4 days of physical activity data recorded via activity monitor during 7 days prior to visit 101.

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for inclusion in this study.

  • Orthopedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator. Specifically if the patients' condition/ co-morbidities are such that physical activity cannot be increased.
  • Respiratory diseases other than COPD (e.g. asthma)
  • Cognitive reading impairment and/or difficulties to manage electronic devices precluding interaction with the health base and PDA, as judged by the investigator
  • Participating in or scheduled to start a rehabilitation program during the study. If the patient wishes to participate in pulmonary rehabilitation for any reason the patient can be enrolled in the study only at the end of rehabilitation.
  • Women of child-bearing potential who have the intention to become pregnant during the course of the study and pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive β-hCG laboratory test.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992081


Sponsors and Collaborators
Novartis Pharmaceuticals
Innovative Medicines Initiative
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Principal Investigator: Innovative Medicines Initiative PROactive is part of the European Innovative Medicines Initiative (IMI)
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01992081    
Other Study ID Numbers: CIDD001D2101
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: May 2014
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
COPD, Physical Activity, Telecoaching, PROactive