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

COPD Clinical Trial

— PROactive  

Official title:

A 6-month Multicenter Randomized Trial to Evaluate the Impact of the "PROactive Telecoaching Program" on Physical Activity in Patients With COPD

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01992081
• Other study ID #: CIDD001D2101
• Status: Withdrawn
• Phase: Phase 4
• First received: November 11, 2013
• Last updated: April 19, 2017
• Start date: May 2014
• Est. completion date: June 2015

Study information

• Verified date: May 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 ß-hCG laboratory test.

Related Conditions & MeSH terms

• COPD

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Innovative Medicines Initiative

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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