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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: COPD
• Intervention / Treatment: Device: Automated telehealth system; Other: Usual care

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.

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: telehealth system; Other: Usual care; Participants will receive usual care associated with Chronic Obstructive Pulmonary Disease (COPD)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Collaborators: Innovative Medicines Initiative
• Investigators: Principal Investigator: Innovative Medicines Initiative, PROactive is part of the European Innovative Medicines Initiative (IMI)

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: COPD, Physical Activity, Telecoaching, PROactive
• Other Study ID Numbers: CIDD001D2101