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

NCT ID: NCT01992081

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-06-30

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.

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Automated telehealth system

Intervention Type: 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.

Usual care

Intervention Type: OTHER

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.

Group Type: OTHER

Usual care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Usual care

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

Intervention Type: OTHER

Other Intervention Names

telehealth system

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovative Medicines Initiative

OTHER

Sponsor Role: collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Innovative Medicines Initiative

Role: PRINCIPAL_INVESTIGATOR

PROactive is part of the European Innovative Medicines Initiative (IMI)

Other Identifiers

CIDD001D2101

Identifier Type: -

Identifier Source: org_study_id